├── .gitignore ├── LICENSE ├── README.md ├── ReadMe.txt ├── build.xml ├── dist └── RunChanges.bat ├── docs ├── SDTM Terminology 2015-06-26.txt └── SDTM Terminology 2015-09-25.txt ├── jar └── cdiscversiondiff.jar ├── scripts └── RunChanges.bat ├── src └── gov │ └── nih │ └── nci │ └── evs │ └── cdisc │ ├── Change.java │ ├── Codelist.java │ ├── Diff.java │ └── Element.java └── test ├── lib ├── assertj-core-3.22.0.jar ├── commons-io-2.11.0.jar ├── hamcrest-2.2.jar ├── junit-jupiter-5.8.2.jar ├── junit-jupiter-api-5.8.2.jar ├── junit-jupiter-engine-5.8.2.jar ├── junit-jupiter-params-5.8.2.jar ├── junit-platform-commons-1.8.2.jar └── junit-platform-engine-1.8.2.jar ├── resources └── fixtures │ └── report-files │ ├── current │ ├── ADaM Terminology.txt │ ├── CDASH Terminology.txt │ ├── Define-XML Terminology.txt │ ├── Glossary Terminology.txt │ ├── Protocol Terminology.txt │ ├── QRS Terminology.txt │ ├── SDTM Terminology.txt │ └── SEND Terminology.txt │ ├── expected │ ├── ADaM Terminology Changes.txt │ ├── CDASH Terminology Changes.txt │ ├── Define-XML Terminology Changes.txt │ ├── Glossary Terminology Changes.txt │ ├── Protocol Terminology Changes.txt │ ├── QRS Terminology Changes.txt │ ├── SDTM Terminology Changes.txt │ └── SEND Terminology Changes.txt │ └── previous │ ├── ADaM Terminology.txt │ ├── CDASH Terminology.txt │ ├── Define-XML Terminology.txt │ ├── Glossary Terminology.txt │ ├── Protocol Terminology.txt │ ├── QRS Terminology.txt │ ├── SDTM Terminology.txt │ └── SEND Terminology.txt └── src └── gov └── nih └── nci └── evs └── cdisc └── DiffTest.java /.gitignore: -------------------------------------------------------------------------------- 1 | dist/ 2 | classes/ 3 | /nci-diff-CDISC.iml 4 | /.idea/ 5 | /out/ 6 | -------------------------------------------------------------------------------- /LICENSE: -------------------------------------------------------------------------------- 1 | Copyright (c) 2015, National Cancer Informatics Program 2 | All rights reserved. 3 | 4 | Redistribution and use in source and binary forms, with or without 5 | modification, are permitted provided that the following conditions are met: 6 | 7 | * Redistributions of source code must retain the above copyright notice, this 8 | list of conditions and the following disclaimer. 9 | 10 | * Redistributions in binary form must reproduce the above copyright notice, 11 | this list of conditions and the following disclaimer in the documentation 12 | and/or other materials provided with the distribution. 13 | 14 | * Neither the name of nci-diff-CDISC nor the names of its 15 | contributors may be used to endorse or promote products derived from 16 | this software without specific prior written permission. 17 | 18 | THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" 19 | AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE 20 | IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE 21 | DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE 22 | FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL 23 | DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR 24 | SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER 25 | CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, 26 | OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE 27 | OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. 28 | 29 | -------------------------------------------------------------------------------- /README.md: -------------------------------------------------------------------------------- 1 | # nci-diff-CDISC 2 | diff specific for CDISC reports 3 | 4 | CDISC Changes Report Generator v2.1 5 | =================================== 6 | 7 | This program will generate a changes report between two CDISC releases. 8 | The releases may span any amount of time. 9 | 10 | Requirements (with install commands for *nix gurus) 11 | --------------------------------------------------- 12 | Git (sudo apt-get install git) 13 | 14 | Apache Ant (sudo apt-get install ant) 15 | 16 | Java Developers Kit (sudo apt-get install openjdk-8-jdk) 17 | 18 | Building the program 19 | -------------------- 20 | 21 | Download this entire project as a .zip. 22 | 23 | OR 24 | 25 | Clone the DiffCDISC repository onto your local filesystem using Git: 26 | 27 | C:\> git clone https://github.com/NCIEVS/nci-diff-CDISC.git 28 | 29 | Open a Command Prompt and navigate to the repository directory. 30 | 31 | Run an ant build 32 | 33 | C:\DiffCDISC> ant build 34 | 35 | This will create a 'classes' and add a jar file to the 'dist' directory 36 | where program dependancies are stored. The program is now ready to run. 37 | 38 | NOTE: If the build fails, you may need to inspect your ant configurations. 39 | See: https://ant.apache.org/manual/ 40 | 41 | Preparing data for the program 42 | ------------------------------ 43 | 44 | Users should pull two reports in .txt format from the same EVS CDISC 45 | Archive directory (e.g., ADaM, SDTM, SEND). 46 | 47 | Included in this repository are two example reports from the SDTM Archive 48 | directory. The example below will demonstrate how to run the program 49 | using these two files. 50 | 51 | Running the program 52 | ------------------- 53 | 54 | Each report is input into the program (newest followed by oldest), 55 | followed by a "release date" and then the filename of the output. 56 | 57 | C:\DiffCDISC\dist>RunChanges "..\docs\SDTM Terminology 2015-09-25.txt" "..\docs\SDTM Terminology 2015-06-26.txt" "9/25/2015" Changes.txt 58 | 59 | Initializing diff report... 60 | 61 | Getting changes... 62 | 63 | Printing changes report... 64 | 65 | About the program 66 | ----------------- 67 | 68 | The following changes between CDISC releases are detected. In the event 69 | of an Update, original and new values are reported. 70 | 71 | - Add new CDISC Synonym 72 | - Add new term to existing codelist 73 | - Add new term to new codelist 74 | - Addition of new codelist 75 | - Remove CDISC Synonym 76 | - Remove term entirely from codelist 77 | - Remove term from retired codelist 78 | - Retire codelist 79 | - Update CDISC Codelist Name 80 | - Update CDISC Definition 81 | - Update CDISC Extensible List 82 | - Update CDISC Submission Value 83 | - Update CDISC Synonym 84 | - Update NCI Preferred Term 85 | 86 | Known issues 87 | ------------ 88 | 89 | The 'Request Code' column will always be empty as they are stored in the 90 | JIRA tracking system. This column is manually populated by EVS before 91 | each quarterly release. 92 | 93 | Version 2.0 was implemented in 2015 94 | Version 2.1 was implemented after Q2 2017 95 | 96 | Release notes between 1.0 and 2.0 97 | --------------------------------- 98 | 99 | 1. Initialize the diff program if and only if there are 4 program arguments 100 | 2. The "Request Code" column values no longer appear as "unknown" (they are now empty) 101 | 3. Reported changes on non-differing Codelists have been removed 102 | 4. Report changes on removed Codelists 103 | 5. Verbaige updates to "Change Types" ("Add" or "Remove" on "CDISC Synonyms" is now just "Update" for existing codelists.) 104 | 6. Improved handling of inputs 105 | 106 | 2.0 and 2.1 107 | ----------- 108 | 1. Default character set for input Scanner is now windows-1252 to allow reported differences on special characters such as non-breaking spaces. 109 | -------------------------------------------------------------------------------- /ReadMe.txt: -------------------------------------------------------------------------------- 1 | CDISC Changes Report Generator v2.1 2 | =================================== 3 | 4 | This program will generate a changes report between two CDISC releases. 5 | The releases may span any amount of time. 6 | 7 | Requirements (with install commands for *nix gurus) 8 | --------------------------------------------------- 9 | Git (sudo apt-get install git) 10 | Apache Ant (sudo apt-get install ant) 11 | Java Developers Kit (sudo apt-get install openjdk-8-jdk) 12 | 13 | Building the program 14 | -------------------- 15 | 16 | Download this entire project as a .zip. 17 | 18 | OR 19 | 20 | Clone the DiffCDISC repository onto your local filesystem using Git: 21 | 22 | C:\> git clone https://github.com/NCIEVS/diff-cdisc.git 23 | 24 | Open a Command Prompt and navigate to the repository directory. 25 | 26 | Run an ant build 27 | 28 | C:\DiffCDISC> ant build 29 | 30 | This will create a 'classes' and add a jar file to the 'dist' directory 31 | where program dependancies are stored. The program is now ready to run. 32 | 33 | NOTE: If the build fails, you may need to inspect your ant configurations. 34 | See: https://ant.apache.org/manual/ 35 | 36 | Preparing data for the program 37 | ------------------------------ 38 | 39 | Users should pull two reports in .txt format from the same EVS CDISC 40 | Archive directory (e.g., ADaM, SDTM, SEND). 41 | 42 | Included in this repository are two example reports from the SDTM Archive 43 | directory. The example below will demonstrate how to run the program 44 | using these two files. 45 | 46 | Running the program 47 | ------------------- 48 | 49 | Each report is input into the program (newest followed by oldest), 50 | followed by a "release date" and then the filename of the output. 51 | 52 | C:\DiffCDISC\dist>RunChanges "..\docs\SDTM Terminology 2015-09-25.txt" "..\docs\SDTM Terminology 2015-06-26.txt" "9/25/2015" Changes.txt 53 | Initializing diff report... 54 | Getting changes... 55 | Printing changes report... 56 | 57 | About the program 58 | ----------------- 59 | 60 | The following changes between CDISC releases are detected. In the event 61 | of an Update, original and new values are reported. 62 | 63 | - Add new CDISC Synonym 64 | - Add new term to existing codelist 65 | - Add new term to new codelist 66 | - Addition of new codelist 67 | - Remove CDISC Synonym 68 | - Remove term entirely from codelist 69 | - Remove term from retired codelist 70 | - Retire codelist 71 | - Update CDISC Codelist Name 72 | - Update CDISC Definition 73 | - Update CDISC Extensible List 74 | - Update CDISC Submission Value 75 | - Update CDISC Synonym 76 | - Update NCI Preferred Term 77 | 78 | Known issues 79 | ------------ 80 | 81 | The 'Request Code' column will always be empty as they are stored in the 82 | JIRA tracking system. This column is manually populated by EVS before 83 | each quarterly release. 84 | 85 | Version 2.0 was implemented in 2015 86 | Version 2.1 was implemented in Q2 of 2017 87 | 88 | Release notes between 1.0 and 2.0 89 | --------------------------------- 90 | 91 | 1. Initialize the diff program if and only if there are 4 program arguments 92 | 2. The "Request Code" column values no longer appear as "unknown" (they are now empty) 93 | 3. Reported changes on non-differing Codelists have been removed 94 | 4. Report changes on removed Codelists 95 | 5. Verbaige updates to "Change Types" ("Add" or "Remove" on "CDISC Synonyms" is now just "Update" for existing codelists.) 96 | 6. Improved handling of inputs 97 | 98 | 2.0 and 2.1 99 | ----------- 100 | 1. Default character set for input Scanner is now windows-1252 to allow reported differences on special characters such as non-breaking spaces. 101 | -------------------------------------------------------------------------------- /build.xml: -------------------------------------------------------------------------------- 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | -------------------------------------------------------------------------------- /dist/RunChanges.bat: -------------------------------------------------------------------------------- 1 | @echo off 2 | java -cp "DiffCDISC.jar" gov.nih.nci.evs.cdisc.Diff %* -------------------------------------------------------------------------------- /jar/cdiscversiondiff.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/jar/cdiscversiondiff.jar -------------------------------------------------------------------------------- /scripts/RunChanges.bat: -------------------------------------------------------------------------------- 1 | @echo off 2 | java -cp "DiffCDISC.jar" gov.nih.nci.evs.cdisc.Diff %* -------------------------------------------------------------------------------- /src/gov/nih/nci/evs/cdisc/Change.java: -------------------------------------------------------------------------------- 1 | package gov.nih.nci.evs.cdisc; 2 | 3 | public class Change { 4 | private String releaseDate; 5 | private String requestCode; 6 | private String changeType; 7 | private String code; 8 | private String termType; 9 | private String codelistShortName; 10 | private String codelistLongName; 11 | private String changeSummary; 12 | private String originalValue; 13 | private String newValue; 14 | private int noCCode; 15 | 16 | public Change(String relDate, String reqCode, String chType, String c, String tType, String clsn, String clln, String cs, String ov, String nv) { 17 | this.releaseDate = relDate; 18 | this.requestCode = reqCode; 19 | this.changeType = chType; 20 | this.code = c; 21 | this.noCCode = Integer.parseInt(code.replace("C", "")); 22 | this.termType = tType; 23 | this.codelistShortName = clsn; 24 | this.codelistLongName = clln; 25 | this.changeSummary = cs; 26 | this.originalValue = ov; 27 | this.newValue = nv; 28 | } 29 | 30 | public String getReleaseDate() { 31 | return this.releaseDate; 32 | } 33 | 34 | public String getRequestCode() { 35 | return this.requestCode; 36 | } 37 | 38 | public String getChangeType() { 39 | return this.changeType; 40 | } 41 | 42 | public String getCode() { 43 | return this.code; 44 | } 45 | 46 | public String getTermType() { 47 | return this.termType; 48 | } 49 | 50 | public String getShortName() { 51 | return this.codelistShortName; 52 | } 53 | 54 | public String getLongName() { 55 | return this.codelistLongName; 56 | } 57 | 58 | public String getChangeSummary() { 59 | return this.changeSummary; 60 | } 61 | 62 | public String getOriginalValue() { 63 | return this.originalValue; 64 | } 65 | 66 | public String getNewValue() { 67 | return this.newValue; 68 | } 69 | 70 | public int getNoCCode() { 71 | return this.noCCode; 72 | } 73 | 74 | public String toString() { 75 | return this.releaseDate + "\t" + this.requestCode + "\t" + this.changeType + "\t" + 76 | this.code + "\t" + this.termType + "\t" + this.codelistShortName + "\t" + this.codelistLongName + "\t" + 77 | this.changeSummary + "\t" + this.originalValue + "\t" + this.newValue + "\n"; 78 | } 79 | 80 | } 81 | -------------------------------------------------------------------------------- /src/gov/nih/nci/evs/cdisc/Codelist.java: -------------------------------------------------------------------------------- 1 | package gov.nih.nci.evs.cdisc; 2 | 3 | public class Codelist { 4 | private String code; 5 | private String extensible; 6 | private String name; 7 | private String subValue; 8 | private String[] synonyms; 9 | private String definition; 10 | private String pt; 11 | 12 | public Codelist (String c, String ext, String n, String sub, String syns, String def, String ncipt) { 13 | this.code = c; 14 | this.extensible = ext; 15 | this.name = n; 16 | this.subValue = sub; 17 | this.synonyms = syns.split(";"); 18 | for(int i=0; i < synonyms.length; i++) { 19 | synonyms[i] = synonyms[i].trim(); 20 | } 21 | this.definition = def; 22 | this.pt = ncipt; 23 | } 24 | 25 | public String getCode() { 26 | return code; 27 | } 28 | 29 | public String getExtensible() { 30 | return extensible; 31 | } 32 | 33 | public String getName() { 34 | return name; 35 | } 36 | 37 | public String getSubValue() { 38 | return subValue; 39 | } 40 | 41 | public String[] getSynonyms() { 42 | return synonyms; 43 | } 44 | 45 | public String getDefinition() { 46 | return definition; 47 | } 48 | 49 | public String getPT() { 50 | return pt; 51 | } 52 | 53 | } 54 | -------------------------------------------------------------------------------- /src/gov/nih/nci/evs/cdisc/Diff.java: -------------------------------------------------------------------------------- 1 | /* Rob Wynne, MSC 2 | * 3 | * Create a Changes report for an 4 | * old and new CDISC report 5 | * modified by Kim Ong 6 | */ 7 | 8 | 9 | package gov.nih.nci.evs.cdisc; 10 | 11 | import java.io.File; 12 | import java.io.FileNotFoundException; 13 | import java.io.PrintWriter; 14 | import java.util.ArrayList; 15 | import java.util.Arrays; 16 | import java.util.Collections; 17 | import java.util.Comparator; 18 | import java.util.HashMap; 19 | import java.util.Scanner; 20 | import java.util.TreeMap; 21 | import java.util.Vector; 22 | 23 | public class Diff { 24 | 25 | public HashMap> newMap = new HashMap>(); 26 | public HashMap> oldMap = new HashMap>(); 27 | public String releaseDate; 28 | public String requestCode = ""; 29 | // public String changeType = "unknown"; 30 | public Vector changes = new Vector(); 31 | public PrintWriter pw; 32 | 33 | /* 34 | * 0 - new report filename 35 | * 1 - old report filename 36 | * 2 - release date 37 | * 3 - outputfile 38 | */ 39 | public static void main(String args[]) { 40 | Diff report = new Diff(); 41 | if( args.length == 4 ) { 42 | System.out.println("Initializing diff report..."); 43 | report.init(args[0], args[1], args[2], args[3]); 44 | System.out.println("Getting changes..."); 45 | report.getChanges(); 46 | System.out.println("Printing changes report..."); 47 | report.print(); 48 | } 49 | else { 50 | printHelp(); 51 | } 52 | } 53 | 54 | public static void printHelp() { 55 | //TODO: Create batch scripts 56 | System.out.println("Unable to start program due to improper input parameters. Program will exit."); 57 | System.out.println(); 58 | System.out.println("Run as: DiffCDISC [new report text file] [previous report text file] [release date] [output filename]"); 59 | System.out.println("Example: DiffCDISC \"SDTM Terminology.txt\" \"SDTM Terminology 2014-03-28.txt\" \"2014-06-27\" \"D:\\data\\SDTM Changes.txt\""); 60 | System.out.println(); 61 | System.exit(0); 62 | } 63 | 64 | private void config_pw(String fileLoc) { 65 | try { 66 | File file = new File(fileLoc); 67 | pw = new PrintWriter(file); 68 | } catch (Exception e) { 69 | System.out.println("Error in PrintWriter"); 70 | } 71 | } 72 | 73 | public void init(String newReport, String oldReport, String date, String saveDestination) { 74 | newMap = parseCDISC(newReport); 75 | oldMap = parseCDISC(oldReport); 76 | releaseDate = date; 77 | config_pw(saveDestination); 78 | } 79 | 80 | public void getChanges() { 81 | 82 | for(Codelist cl_new : newMap.keySet()) { 83 | boolean found = false; 84 | for(Codelist cl_old : oldMap.keySet() ) { 85 | if( cl_new.getCode().equals(cl_old.getCode()) ) { 86 | found = true; 87 | compareCodelists(cl_new, cl_old); 88 | if( newMap.get(cl_new) != null && oldMap.get(cl_old) != null ) 89 | compareElements(newMap.get(cl_new), oldMap.get(cl_old), cl_new.getSubValue()); 90 | break; 91 | } 92 | } 93 | if( !found ) { 94 | getChangesForNewCodelist(cl_new, newMap.get(cl_new)); 95 | } 96 | } 97 | 98 | for(Codelist cl_old : oldMap.keySet()) { 99 | boolean found = false; 100 | for(Codelist cl_new : newMap.keySet()) { 101 | if(cl_old.getCode().equals(cl_new.getCode()) ) { 102 | found = true; 103 | } 104 | } 105 | if( !found ) { 106 | getChangesForRemovedCodelist(cl_old, oldMap.get(cl_old)); 107 | } 108 | } 109 | } 110 | 111 | public void getChangesForRemovedCodelist(Codelist oldCodelist, ArrayList oldElements) { 112 | changes.add(new Change(releaseDate, requestCode, "Remove", oldCodelist.getCode(), "CDISC Codelist", oldCodelist.getSubValue(), oldCodelist.getName(), "Retire codelist", oldCodelist.getSubValue(), "- - -")); 113 | if( oldElements != null ) { 114 | for(Element e: oldElements) { 115 | changes.add(new Change(releaseDate, requestCode, "Remove", e.getCode(), "Term", oldCodelist.getSubValue(), e.getName(), "Remove term from retired codelist", e.getSubValue(), "- - -")); 116 | } 117 | } 118 | else { 119 | System.out.println("No Terms associated with codelist " + oldCodelist.getName()); 120 | } 121 | } 122 | 123 | public void getChangesForNewCodelist(Codelist newCodelist , ArrayList newElements) { 124 | changes.add(new Change(releaseDate, requestCode, "Add", newCodelist.getCode(), "CDISC Codelist", newCodelist.getSubValue(), newCodelist.getName(), "Addition of new codelist", "- - -", newCodelist.getSubValue())); 125 | if( newElements != null ) { 126 | for(Element e : newElements ) { 127 | changes.add(new Change(releaseDate, requestCode, "Add", e.getCode(), "Term", newCodelist.getSubValue(), e.getName(), "Add new term to new codelist", "- - -", e.getSubValue() )); 128 | } 129 | } 130 | else { 131 | System.out.println("No Terms associated with new codelist " + newCodelist.getName()); 132 | } 133 | } 134 | 135 | public void compareElements(ArrayList els_new, ArrayList els_old, String clShortName ) { 136 | TreeMap newElements = new TreeMap(); 137 | TreeMap oldElements = new TreeMap(); 138 | 139 | for(Element el_new : els_new ) { 140 | newElements.put(el_new.getCode(), el_new); 141 | } 142 | 143 | for(Element el_old : els_old ) { 144 | oldElements.put(el_old.getCode(), el_old); 145 | } 146 | 147 | for(String newCode : newElements.keySet()) { 148 | boolean found = false; 149 | for(String oldCode : oldElements.keySet()) { 150 | if( newCode.equals(oldCode) ) { 151 | found = true; 152 | diffElements(newElements.get(newCode), oldElements.get(oldCode), clShortName); 153 | } 154 | } 155 | if( !found ) { 156 | getChangesForAddingTermToExistingCodelist(newElements.get(newCode), clShortName); 157 | } 158 | } 159 | 160 | for(String oldCode : oldElements.keySet()) { 161 | boolean found = false; 162 | for(String newCode : newElements.keySet()) { 163 | if(oldCode.equals(newCode)) { 164 | found = true; 165 | //no need to diff 166 | } 167 | } 168 | if( !found ) { 169 | getChangesForRemoveTermFromExistingCodelist(oldElements.get(oldCode), clShortName); 170 | } 171 | } 172 | 173 | } 174 | 175 | public void getChangesForRemoveTermFromExistingCodelist(Element e, String clShortName) { 176 | changes.add(new Change(releaseDate, requestCode, "Remove", e.getCode(), "Term", clShortName, e.getName(), "Remove term entirely from codelist", e.getSubValue(), "- - -")); 177 | } 178 | 179 | public void getChangesForAddingTermToExistingCodelist(Element e, String clShortName) { 180 | changes.add(new Change(releaseDate, requestCode, "Add", e.getCode(), "Term", clShortName, e.getName(), "Add new term to existing codelist", "- - -", e.getSubValue())); 181 | } 182 | 183 | public void diffElements( Element newElement, Element oldElement, String clShortName ) { 184 | if( !newElement.getName().equals(oldElement.getName()) ) 185 | changes.add(new Change(releaseDate, requestCode, "Update", newElement.getCode(), "CDISC Codelist Name", clShortName, newElement.getName(), "Update CDISC Codelist Name", oldElement.getName(), newElement.getName())); 186 | if( !newElement.getSubValue().equals(oldElement.getSubValue()) ) 187 | changes.add(new Change(releaseDate, requestCode, "Update", newElement.getCode(), "CDISC Submission Value", clShortName, newElement.getName(), "Update CDISC Submission Value", oldElement.getSubValue(), newElement.getSubValue())); 188 | if( !newElement.getDefinition().equals(oldElement.getDefinition()) ) 189 | changes.add(new Change(releaseDate, requestCode, "Update", newElement.getCode(), "CDISC Definition", clShortName, newElement.getName(), "Update CDISC Definition", oldElement.getDefinition(), newElement.getDefinition())); 190 | if( !newElement.getPT().equals(oldElement.getPT()) ) 191 | changes.add(new Change(releaseDate, requestCode, "Update", newElement.getCode(), "NCI Preferred Term", clShortName, newElement.getName(), "Update NCI Preferred Term", oldElement.getPT(), newElement.getPT())); 192 | String[] old_syns = oldElement.getSynonyms(); 193 | String[] new_syns = newElement.getSynonyms(); 194 | Arrays.sort(old_syns); 195 | Arrays.sort(new_syns); 196 | 197 | //forwards 198 | for(int i=0; i < new_syns.length; i++) { 199 | boolean found = false; 200 | for(int j=0; j < old_syns.length; j++) { 201 | if( new_syns[i].equals(old_syns[j])) { 202 | found = true; 203 | } 204 | } 205 | if( !found ) { 206 | if( !new_syns[i].equals("") ) { 207 | changes.add(new Change(releaseDate, requestCode, "Update", newElement.getCode(), "CDISC Synonym", clShortName, newElement.getName(), "Add new CDISC Synonym", "- - -", new_syns[i])); 208 | } 209 | } 210 | } 211 | 212 | //and backwards 213 | for(int i=0; i < old_syns.length; i++) { 214 | boolean found = false; 215 | for(int j=0; j < new_syns.length; j++) { 216 | if( old_syns[i].equals(new_syns[j])) { 217 | found = true; 218 | } 219 | } 220 | if( !found ) { 221 | if( !old_syns[i].equals("") ) { 222 | changes.add(new Change(releaseDate, requestCode, "Update", newElement.getCode(), "CDISC Synonym", clShortName, newElement.getName(), "Remove CDISC Synonym", old_syns[i], "- - -")); 223 | } 224 | } 225 | } 226 | 227 | } 228 | 229 | public void compareCodelists(Codelist cl_new, Codelist cl_old) { 230 | if( !cl_new.getExtensible().equals(cl_old.getExtensible()) ) 231 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "CDISC Extensible List", cl_new.getSubValue(), cl_new.getName(), "Update CDISC Extensible List", cl_old.getExtensible(), cl_new.getExtensible())); 232 | if( !cl_new.getName().equals(cl_old.getName()) ) 233 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "CDISC Codelist Name", cl_new.getSubValue(), cl_new.getName(), "Update CDISC Codelist Name", cl_old.getName(), cl_new.getName())); 234 | if( !cl_new.getSubValue().equals(cl_old.getSubValue()) ) 235 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "CDISC Submission Value", cl_new.getSubValue(), cl_new.getName(), "Update CDISC Submission Value", cl_old.getSubValue(), cl_new.getSubValue())); 236 | if( !cl_new.getDefinition().equals(cl_old.getDefinition()) ) 237 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "CDISC Definition", cl_new.getSubValue(), cl_new.getName(), "Update CDISC Definition", cl_old.getDefinition(), cl_new.getDefinition())); 238 | if( !cl_new.getPT().equals(cl_old.getPT()) ) 239 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "NCI Preferred Term", cl_new.getSubValue(), cl_new.getName(), "Update NCI Preferred Term", cl_old.getPT(), cl_new.getPT())); 240 | String[] old_syns = cl_old.getSynonyms(); 241 | String[] new_syns = cl_new.getSynonyms(); 242 | Arrays.sort(old_syns); 243 | Arrays.sort(new_syns); 244 | 245 | //forwards 246 | for(int i=0; i < new_syns.length; i++) { 247 | boolean found = false; 248 | for(int j=0; j < old_syns.length; j++) { 249 | if( new_syns[i].equals(old_syns[j])) { 250 | found = true; 251 | } 252 | } 253 | if( !found ) { 254 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "CDISC Synonym", cl_new.getSubValue(), cl_new.getName(), "Add new CDISC Synonym", "- - -", new_syns[i])); 255 | } 256 | } 257 | 258 | //and backwards 259 | for(int i=0; i < old_syns.length; i++) { 260 | boolean found = false; 261 | for(int j=0; j < new_syns.length; j++) { 262 | if( old_syns[i].equals(new_syns[j])) { 263 | found = true; 264 | } 265 | } 266 | if( !found ) { 267 | changes.add(new Change(releaseDate, requestCode, "Update", cl_new.getCode(), "CDISC Synonym", cl_new.getSubValue(), cl_new.getName(), "Remove CDISC Synonym", old_syns[i], "- - -")); 268 | } 269 | } 270 | } 271 | 272 | public HashMap> parseCDISC(String filename) { 273 | HashMap> map = new HashMap>(); 274 | 275 | try { 276 | Scanner input = new Scanner(new File(filename), "windows-1252"); 277 | int lineNum = 0; 278 | while(input.hasNext()) { 279 | lineNum++; 280 | String line = input.nextLine().trim(); 281 | String[] tokens = line.split("\t"); 282 | 283 | if( tokens.length == 8 ) { 284 | /* 0 - Code 285 | * 1 - Codelist Code 286 | * 2 - Extensible (codelist only) 287 | * 3 - Codelist Name 288 | * 4 - Submission Value 289 | * 5 - Synonyms 290 | * 6 - Definition 291 | * 7 - PT 292 | */ 293 | String code = tokens[0]; 294 | String codelistCode = tokens[1]; 295 | String extensible = tokens[2]; 296 | String codelistName = tokens[3]; 297 | String subValue = tokens[4]; 298 | String synonyms = tokens[5]; 299 | String definition = tokens[6]; 300 | String pt = tokens[7]; 301 | // KLO, 10062021 302 | //if( !extensible.equals("") ) { 303 | if( !code.equals("") && codelistCode.equals("")) { 304 | Codelist cl = new Codelist(code, extensible, codelistName, subValue, synonyms, definition, pt); 305 | map.put(cl, null); 306 | } 307 | else { 308 | Element e = new Element(code, codelistCode, codelistName, subValue, synonyms, definition, pt); 309 | boolean found = false; 310 | for(Codelist cl : map.keySet()) { 311 | if(cl.getCode().equals(e.getCodelistCode())) { 312 | found = true; 313 | ArrayList tmp = map.get(cl); 314 | if( tmp == null ) { 315 | tmp = new ArrayList(); 316 | tmp.add(e); 317 | map.put(cl, tmp); 318 | } 319 | else { 320 | tmp.add(e); 321 | map.put(cl, tmp); 322 | } 323 | break; //seen enough 324 | } 325 | } 326 | if( !found ) { 327 | System.err.println("Unable to find the codelist " + e.getCodelistCode() + " for element " + e.getCode()); 328 | } 329 | } 330 | } 331 | else { 332 | System.err.println("Unable to read " + filename + ": line " + lineNum); 333 | } 334 | } 335 | input.close(); 336 | } catch (FileNotFoundException e) { 337 | System.err.println("Unable to open and parse file " + filename); 338 | e.printStackTrace(); 339 | } 340 | return map; 341 | } 342 | 343 | public void print() { 344 | 345 | Collections.sort(changes, new Comparator() { 346 | public int compare(final Change change1, final Change change2) { 347 | return change1.getNoCCode() - change2.getNoCCode(); 348 | } 349 | }); 350 | 351 | Collections.sort(changes, new Comparator() { 352 | public int compare(final Change change1, final Change change2) { 353 | return change1.getShortName().compareTo(change2.getShortName()); 354 | } 355 | }); 356 | 357 | pw.println("Release Date" + "\t" + "Request Code" + "\t" + "Change Type" + "\t" + 358 | "NCI Code" + "\t" + "CDISC Term Type" + "\t" + "CDISC Codelist (Short Name)" + 359 | "\t" + "CDISC Codelist (Long Name)" + "\t" + "Change Summary" + "\t" + "Original" + "\t" + "New" + 360 | "\t" + "Change Implementation Instructions"); 361 | 362 | for(Change c : changes ) { 363 | pw.print(c.toString()); 364 | } 365 | pw.close(); 366 | } 367 | 368 | } 369 | -------------------------------------------------------------------------------- /src/gov/nih/nci/evs/cdisc/Element.java: -------------------------------------------------------------------------------- 1 | package gov.nih.nci.evs.cdisc; 2 | 3 | public class Element { 4 | private String code; 5 | private String codelistCode; 6 | private String name; 7 | private String subValue; 8 | private String[] synonyms; 9 | private String definition; 10 | private String pt; 11 | 12 | public Element(String c, String cc, String n, String sub, String syns, String def, String ncipt) { 13 | this.code = c; 14 | this.codelistCode = cc; 15 | this.name = n; 16 | this.subValue = sub; 17 | this.synonyms = syns.split(";"); 18 | for(int i=0; i < synonyms.length; i++) { 19 | synonyms[i] = synonyms[i].trim(); 20 | } 21 | this.definition = def; 22 | this.pt = ncipt; 23 | } 24 | 25 | public String getCode() { 26 | return this.code; 27 | } 28 | 29 | public String getCodelistCode() { 30 | return this.codelistCode; 31 | } 32 | 33 | public String getName() { 34 | return this.name; 35 | } 36 | 37 | public String getSubValue() { 38 | return this.subValue; 39 | } 40 | 41 | public String[] getSynonyms() { 42 | return this.synonyms; 43 | } 44 | 45 | public String getDefinition() { 46 | return this.definition; 47 | } 48 | 49 | public String getPT() { 50 | return this.pt; 51 | } 52 | } 53 | -------------------------------------------------------------------------------- /test/lib/assertj-core-3.22.0.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/assertj-core-3.22.0.jar -------------------------------------------------------------------------------- /test/lib/commons-io-2.11.0.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/commons-io-2.11.0.jar -------------------------------------------------------------------------------- /test/lib/hamcrest-2.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/hamcrest-2.2.jar -------------------------------------------------------------------------------- /test/lib/junit-jupiter-5.8.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/junit-jupiter-5.8.2.jar -------------------------------------------------------------------------------- /test/lib/junit-jupiter-api-5.8.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/junit-jupiter-api-5.8.2.jar -------------------------------------------------------------------------------- /test/lib/junit-jupiter-engine-5.8.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/junit-jupiter-engine-5.8.2.jar -------------------------------------------------------------------------------- /test/lib/junit-jupiter-params-5.8.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/junit-jupiter-params-5.8.2.jar -------------------------------------------------------------------------------- /test/lib/junit-platform-commons-1.8.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/junit-platform-commons-1.8.2.jar -------------------------------------------------------------------------------- /test/lib/junit-platform-engine-1.8.2.jar: -------------------------------------------------------------------------------- https://raw.githubusercontent.com/NCIEVS/nci-diff-CDISC/17562789661ce1db7e9fbb9ee0d75044dd5cd6d2/test/lib/junit-platform-engine-1.8.2.jar -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/current/ADaM Terminology.txt: -------------------------------------------------------------------------------- 1 | Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term 2 | C81223 No Date Imputation Flag DATEFL Date Imputation Flag Date Imputation Flag: Indicates the level of imputation reflected in a date value. CDISC ADaM Date Imputation Flag Terminology 3 | C81212 C81223 Date Imputation Flag D Day Imputed: Day is imputed. Day Imputed 4 | C81211 C81223 Date Imputation Flag M Month Imputed: Month and day are imputed. Month Day Imputed 5 | C81210 C81223 Date Imputation Flag Y Year Imputed: Entire date (year, month and day) is imputed. Year Month Day Imputed 6 | C81224 Yes Derivation Type DTYPE Derivation Type Derivation Type: Analysis value derivation method. CDISC ADaM Derivation Type Terminology 7 | C81209 C81224 Derivation Type AVERAGE Average A data derivation or imputation technique which sets the analysis value on the record to the subject's average value over a defined set of records. Average of Value Derivation Technique 8 | C92225 C81224 Derivation Type BC Best Case A data derivation or imputation technique which sets the analysis value on the record to the best possible outcome. Best Case Imputation Technique 9 | C81201 C81224 Derivation Type BLOCF Baseline Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's non-missing baseline observation. Baseline Observation Carried Forward Imputation Technique 10 | C132340 C81224 Derivation Type BOC Best Observed Case A data derivation or imputation technique which sets the analysis value on the record to the best outcome recorded within a subject. Best Observed Case Imputation Technique 11 | C92226 C81224 Derivation Type BOCF Best Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's previous best-case non-missing value. Best Observation Carried Forward Imputation Technique 12 | C184383 C81224 Derivation Type COPY A technique that uses assignment logic to duplicate an analysis value to be used in additional evaluations. Copy Duplication Imputation Technique 13 | C139176 C81224 Derivation Type EXTRAP Extrapolation A data derivation or imputation technique which sets the analysis value on the record to an estimation of a value based on extending a known sequence of values. Extrapolation Imputation Technique 14 | C170546 C81224 Derivation Type HALFLLOQ One Half of Lower Limit of Quantification A data derivation or imputation technique which sets the analysis value on the record to one half of the lower limit of quantification of a test. One Half of Lower Limit of Quantification Derivation Technique 15 | C81208 C81224 Derivation Type INTERP Interpolation A data derivation or imputation technique which sets the analysis value on the record to a function of known values to estimate a value within the range. Interpolation Imputation Technique 16 | C105701 C81224 Derivation Type LLOD Lower Limit of Detection A data derivation or imputation technique which sets the analysis value on the record to the lower limit of detection of a test. Detection Limit 17 | C170543 C81224 Derivation Type LLOQ Lower Limit of Quantification A data derivation or imputation technique which sets the analysis value on the record to the lower limit of quantification of a test. Lower Limit of Quantification Derivation Technique 18 | C81198 C81224 Derivation Type LOCF Last Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's previous non-missing value. Last Observation Carried Forward Imputation Technique 19 | C132341 C81224 Derivation Type LOV Last Observed Value A data derivation or imputation technique which sets the analysis value on the record to the subject's last recorded non-missing observation. Last Observed Value Imputation Technique 20 | C132342 C81224 Derivation Type LVPD Last Value Prior to Dosing A data derivation or imputation technique which sets the analysis value on the record to the subject's last observed value prior to the start of study treatment. Last Value Prior to Dosing Imputation Technique 21 | C82868 C81224 Derivation Type MAXIMUM Maximum A data derivation or imputation technique which sets the analysis value on the record to the subject's maximum value over a defined set of records. Maximum Value Derivation Technique 22 | C82867 C81224 Derivation Type MINIMUM Minimum A data derivation or imputation technique which sets the analysis value on the record to the subject's minimum value over a defined set of records. Minimum Value Derivation Technique 23 | C53331 C81224 Derivation Type ML Maximum Likelihood A data derivation or imputation technique which sets the analysis value on the record to the estimate that maximizes the probability of observing what has in fact been observed. Maximum Likelihood Estimation 24 | C81204 C81224 Derivation Type MOTH Mean of Other Group A data derivation or imputation technique which sets the analysis value on the record to the mean value from a comparator or reference group. Mean of Other Group Imputation Technique 25 | C81207 C81224 Derivation Type MOV Mean Observed Value in a Group A data derivation or imputation technique which sets the analysis value on the record to the mean value observed in a group of subjects. Mean Observed Value in a Group Imputation Technique 26 | C170545 C81224 Derivation Type PHANTOM Phantom Record A technique that creates a record with a missing analysis value when there is no observed record for a given analysis visit or analysis timepoint. Phantom Record Imputation Technique 27 | C81205 C81224 Derivation Type POCF Penultimate Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's next-to-last non-missing value. Penultimate Observation Carried Forward Imputation Technique 28 | C81200 C81224 Derivation Type SOCF Screening Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's non-missing screening observation. Screening Observation Carried Forward Imputation Technique 29 | C174264 C81224 Derivation Type ULOD Upper Limit of Detection A data derivation or imputation technique which sets the analysis value on the record to the upper limit of detection of a test. Upper Limit of Detection Imputation Technique 30 | C170544 C81224 Derivation Type ULOQ Upper Limit of Quantification A data derivation or imputation technique which sets the analysis value on the record to the upper limit of quantification of a test. Upper Limit of Quantification Derivation Technique 31 | C81203 C81224 Derivation Type WC Worst Case A data derivation or imputation technique which sets the analysis value on the record to the worst possible outcome. Worst Case Imputation Technique 32 | C132343 C81224 Derivation Type WOC Worst Observed Case A data derivation or imputation technique which sets the analysis value on the record to the worst recorded outcome within a subject. Worst Observed Case Imputation Technique 33 | C81199 C81224 Derivation Type WOCF Worst Observed Value Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's worst-case non-missing observation. Worst Observation Carried Forward Imputation Technique 34 | C81206 C81224 Derivation Type WOV Worst Observed Value in a Group A data derivation or imputation technique which sets the analysis value on the record to the worst value observed in a group of subjects. Worst Observed Value in a Group Imputation Technique 35 | C172334 No Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Code GAD02PC Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Code A parameter code codelist for the Generalized Anxiety Disorder - 7 Version 2 Questionnaire (GAD-7 V2) to support the calculation of total score in ADaM. CDISC ADaM Generalized Anxiety Disorder-7 Version 2 Questionnaire Parameter Code Terminology 36 | C172451 C172334 Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Code GAD02TS GAD02-Total Score - Analysis Generalized Anxiety Disorder - 7 Version 2 - Total score used for analysis. Generalized Anxiety Disorder - 7 Version 2 - Analysis 37 | C172335 No Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Name GAD02PN Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Name A parameter name codelist for the Generalized Anxiety Disorder - 7 Version 2 Questionnaire (GAD-7 V2) to support the calculation of total score in ADaM. CDISC ADaM Generalized Anxiety Disorder-7 Version 2 Questionnaire Parameter Name Terminology 38 | C172451 C172335 Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Name GAD02-Total Score - Analysis GAD02-Total Score - Analysis Generalized Anxiety Disorder - 7 Version 2 - Total score used for analysis. Generalized Anxiety Disorder - 7 Version 2 - Analysis 39 | C158114 No Geriatric Depression Scale Short Form Questionnaire Parameter Code GDS02PC Geriatric Depression Scale Short Form Questionnaire Parameter Code A parameter code codelist for the Geriatric Depression Scale Short Form questionnaire (GDS02) to support the calculation of total score in ADaM. CDISC ADaM Geriatric Depression Scale Short Form Questionnaire Parameter Code Terminology 40 | C158155 C158114 Geriatric Depression Scale Short Form Questionnaire Parameter Code GDS02TS GDS02-Total Score - Analysis Geriatric Depression Scale Short Form - Total score used for analysis. Geriatric Depression Scale Short Form - Total Score 41 | C158115 No Geriatric Depression Scale Short Form Questionnaire Parameter Name GDS02PN Geriatric Depression Scale Short Form Questionnaire Parameter Name A parameter name codelist for the Geriatric Depression Scale Short Form questionnaire (GDS02) to support the calculation of total score in ADaM. CDISC ADaM Geriatric Depression Scale Short Form Questionnaire Parameter Name Terminology 42 | C158155 C158115 Geriatric Depression Scale Short Form Questionnaire Parameter Name GDS02-Total Score - Analysis GDS02-Total Score - Analysis Geriatric Depression Scale Short Form - Total score used for analysis. Geriatric Depression Scale Short Form - Total Score 43 | C81225 No Parameter Type PARAMTYP Parameter Type Parameter Type: Indicates whether the parameter is derived as a function of one or more other parameters. CDISC ADaM Parameter Type Terminology 44 | C81197 C81225 Parameter Type DERIVED Derived: Indicates that a parameter is derived as a function of one or more other parameters. Derived Flag 45 | C165644 Yes Pool for Integration POOLINT Pool for Integration Terminology relevant to the name of the Pool, often defined in the integrated statistical analysis plan, which identifies the combination of subjects' clinical trial experience and will be the focus of the integrated analysis. CDISC ADaM Pool for Integration Terminology 46 | C165858 C165644 Pool for Integration OVERALL The pool that includes data across all studies within which the subject has participated, used for the overall integrated analysis. Overall Pooled Data 47 | C124296 Yes Subject Trial Status SBJTSTAT Subject Trial Status Indicates the status of the subject in the trial. CDISC ADaM Subject Trial Status Terminology 48 | C25250 C124296 Subject Trial Status COMPLETED To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI) Complete 49 | C25484 C124296 Subject Trial Status DISCONTINUED To stop or end, permanently or temporarily. Discontinue 50 | C53279 C124296 Subject Trial Status ONGOING Continuous Remain in force or carry on without letup; keep or maintain in unaltered condition; exist in time or space without stop or interruption. (NCI) Continue 51 | C81226 No Time Imputation Flag TIMEFL Time Imputation Flag Time Imputation Flag: Indicates the level of imputation reflected in a time value. CDISC ADaM Time Imputation Flag Terminology 52 | C81213 C81226 Time Imputation Flag H Hours Imputed: Entire time (hours, minutes and seconds) is imputed. Hours Minutes Seconds Imputed 53 | C81214 C81226 Time Imputation Flag M Minutes Imputed: Minutes and seconds are imputed. Minutes Seconds Imputed 54 | C81215 C81226 Time Imputation Flag S Seconds Imputed: Seconds are imputed. Seconds Imputed 55 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/current/CDASH Terminology.txt: -------------------------------------------------------------------------------- 1 | Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term 2 | C78418 Yes Concomitant Medication Dose Form CMDOSFRM Concomitant Medication Dose Form A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Concomitant Medication Dose Form codelist. (NCI) CDISC CDASH Concomitant Medication Dose Form Terminology 3 | C42887 C78418 Concomitant Medication Dose Form AEROSOL aer A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). Aerosol Dosage Form 4 | C25158 C78418 Concomitant Medication Dose Form CAPSULE cap A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI) Capsule Dosage Form 5 | C28944 C78418 Concomitant Medication Dose Form CREAM A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Cream Dosage Form 6 | C42933 C78418 Concomitant Medication Dose Form GAS Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) Gas Dosage Form 7 | C42934 C78418 Concomitant Medication Dose Form GEL A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. Gel Dosage Form 8 | C42966 C78418 Concomitant Medication Dose Form OINTMENT oint A suspension or emulsion, semisolid (1) dosage form, usually containing less than 20 percent water and volatiles (2) and greater than 50 percent hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. Ointment Dosage Form 9 | C42968 C78418 Concomitant Medication Dose Form PATCH A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. Patch Dosage Form 10 | C42972 C78418 Concomitant Medication Dose Form POWDER An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) Powder Dosage Form 11 | C42989 C78418 Concomitant Medication Dose Form SPRAY A liquid minutely divided as by a jet of air or steam. (NCI) Spray Dosage Form 12 | C42993 C78418 Concomitant Medication Dose Form SUPPOSITORY supp A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature. Suppository Dosage Form 13 | C42994 C78418 Concomitant Medication Dose Form SUSPENSION Ready to Use Suspension; susp A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Suspension Dosage Form 14 | C42998 C78418 Concomitant Medication Dose Form TABLET tab A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Tablet Dosage Form 15 | C78417 Yes Concomitant Medication Dose Units CMDOSU Concomitant Medication Dose Units A terminology subset of the CDISC SDTM Unit codelist created for CDASH Concomitant Medication Dose Units codelist. (NCI) CDISC CDASH Concomitant Medication Dose Units Terminology 16 | C48480 C78417 Concomitant Medication Dose Units CAPSULE cap; Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit 17 | C48155 C78417 Concomitant Medication Dose Units g Gram A unit of mass equal to one thousandth (1E-3) of a kilogram, the kilogram being the base unit of mass in the International System of Units (SI). Gram 18 | C48579 C78417 Concomitant Medication Dose Units IU IE; International Unit The unitage assigned by the WHO (World Health Organization) to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization, to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae.(NCI) International Unit 19 | C28253 C78417 Concomitant Medication Dose Units mg Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram 20 | C28254 C78417 Concomitant Medication Dose Units mL cm3; Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter 21 | C65060 C78417 Concomitant Medication Dose Units PUFF Puff Dosing Unit A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) Puff Dosing Unit 22 | C48542 C78417 Concomitant Medication Dose Units TABLET tab; Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit 23 | C48152 C78417 Concomitant Medication Dose Units ug mcg; Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram 24 | C78419 Yes Concomitant Medication Dosing Frequency per Interval CMDOSFRQ Concomitant Medication Dosing Frequency per Interval A terminology subset of the CDISC SDTM Frequency codelist created for CDASH Concomitant Medication Dosing Frequency per Interval codelist. (NCI) CDISC CDASH Concomitant Medication Dosing Frequency per Interval Terminology 25 | C64496 C78419 Concomitant Medication Dosing Frequency per Interval BID BD; Twice per day Two times per day, at unspecified times. (NCI) Twice Daily 26 | C64499 C78419 Concomitant Medication Dosing Frequency per Interval PRN As needed As needed. (NCI) As Needed 27 | C25473 C78419 Concomitant Medication Dosing Frequency per Interval QD /day; Daily; Per Day A rate of occurrences within a period of time equal to one day. Daily 28 | C64530 C78419 Concomitant Medication Dosing Frequency per Interval QID 4 times per day Four times per day. (NCI) Four Times Daily 29 | C64498 C78419 Concomitant Medication Dosing Frequency per Interval QM Every Month; Per Month Every month. (NCI) Monthly 30 | C64525 C78419 Concomitant Medication Dosing Frequency per Interval QOD Every other day; Every Second Day; Every Two Days; Q2D Every other day. (NCI) Every Other Day 31 | C64527 C78419 Concomitant Medication Dosing Frequency per Interval TID 3 times per day Three times per day. (NCI) Three Times Daily 32 | C17998 C78419 Concomitant Medication Dosing Frequency per Interval UNKNOWN U; UNK; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown 33 | C78420 Yes Concomitant Medication Route of Administration CMROUTE Concomitant Medication Route of Administration A terminology subset of the CDISC SDTM Route codelist created for CDASH Concomitant Medication Route of Administration codelist. (NCI) CDISC CDASH Concomitant Medication Route of Administration Terminology 34 | C38250 C78420 Concomitant Medication Route of Administration INTRALESIONAL Administration within or introduced directly into a localized lesion. (FDA) Intralesional Route of Administration 35 | C28161 C78420 Concomitant Medication Route of Administration INTRAMUSCULAR Administration within a muscle. (FDA) Intramuscular Route of Administration 36 | C38255 C78420 Concomitant Medication Route of Administration INTRAOCULAR Administration within the eye. (FDA) Intraocular Route of Administration 37 | C38258 C78420 Concomitant Medication Route of Administration INTRAPERITONEAL Administration within the peritoneal cavity. (FDA) Intraperitoneal Route of Administration 38 | C38284 C78420 Concomitant Medication Route of Administration NASAL Intranasal Route of Administration Administration to the nose; administered by way of the nose. (FDA) Nasal Route of Administration 39 | C38288 C78420 Concomitant Medication Route of Administration ORAL Intraoral Route of Administration; PO Administration to or by way of the mouth. (FDA) Oral Route of Administration 40 | C38295 C78420 Concomitant Medication Route of Administration RECTAL Administration to the rectum. (FDA) Rectal Route of Administration 41 | C38216 C78420 Concomitant Medication Route of Administration RESPIRATORY (INHALATION) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) Inhalation Route of Administration 42 | C38299 C78420 Concomitant Medication Route of Administration SUBCUTANEOUS SC; Subdermal Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) Subcutaneous Route of Administration 43 | C38304 C78420 Concomitant Medication Route of Administration TOPICAL TOP Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. (FDA) Topical Route of Administration 44 | C38305 C78420 Concomitant Medication Route of Administration TRANSDERMAL Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Transdermal Route of Administration 45 | C38313 C78420 Concomitant Medication Route of Administration VAGINAL Administration into the vagina. (FDA) Vaginal Route of Administration 46 | C78422 Yes ECG Original Units EGORRESU ECG Original Units A terminology subset of the CDISC SDTM Unit codelist created for CDASH ECG Original Units codelist. (NCI) CDISC CDASH ECG Original Units Terminology 47 | C49673 C78422 ECG Original Units beats/min Beats per Minute; bpm; BPM The number of heartbeats measured per minute time. (NCI) Beats per Minute 48 | C41140 C78422 ECG Original Units msec Millisecond; ms A unit of time, which is equal to one thousandth of a second.(NCI) Millisecond 49 | C42535 C78422 ECG Original Units sec Second The base unit of time in the International System of Units (SI) equal to the duration of 9,192,631,770 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. Second 50 | C128690 Yes Ethnicity As Collected ETHNICC Ethnicity As Collected A terminology codelist relevant to the ethnicity of an individual as collected on the case report form. CDISC SDTM Collected Ethnicity Terminology 51 | C158197 C128690 Ethnicity As Collected ACHANG AC A Chinese person from the Achang ethnic group. Achang Chinese 52 | C17950 C128690 Ethnicity As Collected ASHKENAZI JEW A person of Ashkenazi Jewish descent. Ashkenazi Jew 53 | C158171 C128690 Ethnicity As Collected BAI BA A Chinese person from the Bai ethnic group. Bai Chinese 54 | C158193 C128690 Ethnicity As Collected BLANG BL A Chinese person from the Blang ethnic group. Blang Chinese 55 | C158203 C128690 Ethnicity As Collected BONAN BN A Chinese person from the Bonan ethnic group. Bonan Chinese 56 | C158169 C128690 Ethnicity As Collected BUYEI BY A Chinese person from the Buyei ethnic group. Buyei Chinese 57 | C67118 C128690 Ethnicity As Collected CENTRAL AMERICAN A person of Central American descent. Central American 58 | C158172 C128690 Ethnicity As Collected CHOSEN CS A Chinese person from the Chosen ethnic group. Chosen Chinese 59 | C67115 C128690 Ethnicity As Collected CUBAN AMERICAN A person of Cuban and American descent. Cuban or Cuban American 60 | C107608 C128690 Ethnicity As Collected CUBAN A person of Cuban descent. Cuban 61 | C158176 C128690 Ethnicity As Collected DAI DA A Chinese person from the Dai (including several different Tai-speaking groups historically referred to as Bai-yi) ethnic group. Dai Chinese 62 | C158191 C128690 Ethnicity As Collected DAUR DU A Chinese person from the Daur ethnic group. Daur Chinese 63 | C158202 C128690 Ethnicity As Collected DEANG DE A Chinese person from the Deang ethnic group. Deang Chinese 64 | C158209 C128690 Ethnicity As Collected DERUNG DR A Chinese person from the Derung ethnic group. Derung Chinese 65 | C158168 C128690 Ethnicity As Collected DONG DO A Chinese person from the Dong ethnic group. Dong Chinese 66 | C158179 C128690 Ethnicity As Collected DONGXIANG DX A Chinese person from the Dongxiang ethnic group. Dongxiang Chinese 67 | C158199 C128690 Ethnicity As Collected EWENKI EW A Chinese person from the Ewenki ethnic group. Ewenki Chinese 68 | C158211 C128690 Ethnicity As Collected GAOSHAN GS A Chinese person from the Gaoshan ethnic group. Gaoshan Chinese 69 | C158180 C128690 Ethnicity As Collected GELAO GL A Chinese person from the Gelao ethnic group. Gelao Chinese 70 | C158200 C128690 Ethnicity As Collected GIN GI A Chinese person from the Gin ethnic group. Gin Chinese 71 | C158158 C128690 Ethnicity As Collected HAN HA A Chinese person from the Han ethnic group (including Chuanqing). Han Chinese 72 | C158173 C128690 Ethnicity As Collected HANI HN A Chinese person from the Hani (including Sangkong) ethnic group. Hani Chinese 73 | C158210 C128690 Ethnicity As Collected HEZHEN HZ A Chinese person from the Hezhen ethnic group. Hezhen Chinese 74 | C17459 C128690 Ethnicity As Collected HISPANIC OR LATINO A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI) Hispanic or Latino 75 | C158160 C128690 Ethnicity As Collected HUI HU A Chinese person from the Hui (including Utsuls of Hainan, descended from Cham refugees) ethnic group. Hui Chinese 76 | C158190 C128690 Ethnicity As Collected JINGPO JP A Chinese person from the Jingpo ethnic group. Jingpo Chinese 77 | C158201 C128690 Ethnicity As Collected JINO JN A Chinese person from the Jino ethnic group. Jino Chinese 78 | C158175 C128690 Ethnicity As Collected KAZAK KZ A Chinese person from the Kazak ethnic group. Kazak Chinese 79 | C158189 C128690 Ethnicity As Collected KIRGIZ KG A Chinese person from the Kirgiz ethnic group. Kirgiz Chinese 80 | C158181 C128690 Ethnicity As Collected LAHU LH A Chinese person from the Lahu ethnic group. Lahu Chinese 81 | C126531 C128690 Ethnicity As Collected LATIN AMERICAN A person of Latin American descent. Latin American 82 | C158212 C128690 Ethnicity As Collected LHOBA LB A Chinese person from the Lhoba ethnic group. Lhoba Chinese 83 | C158174 C128690 Ethnicity As Collected LI LI A Chinese person from the Li ethnic group. Li Chinese 84 | C158178 C128690 Ethnicity As Collected LISU LS A Chinese person from the Lisu ethnic group. Lisu Chinese 85 | C158161 C128690 Ethnicity As Collected MAN MA A Chinese person from the Man ethnic group. Man Chinese 86 | C158194 C128690 Ethnicity As Collected MAONAN MN A Chinese person from the Maonan (including the Then) ethnic group. Maonan Chinese 87 | C67114 C128690 Ethnicity As Collected MEXICAN AMERICAN A person of Mexican and American descent. Mexican American 88 | C67113 C128690 Ethnicity As Collected MEXICAN A person of Mexican descent. Mexican 89 | C158163 C128690 Ethnicity As Collected MIAO MH A Chinese person from the Miao (Including Hmong) ethnic group. Miao Chinese 90 | C158207 C128690 Ethnicity As Collected MONBA MB A Chinese person from the Monba ethnic group. Monba Chinese 91 | C158167 C128690 Ethnicity As Collected MONGOL MG A Chinese person from the Mongol ethnic group. Mongol Chinese 92 | C158187 C128690 Ethnicity As Collected MULAO ML A Chinese person from the Mulao (including the Qago) ethnic group. Mulao Chinese 93 | C158184 C128690 Ethnicity As Collected NAXI NX A Chinese person from the Naxi (including Mosuo) ethnic group. Naxi Chinese 94 | C41222 C128690 Ethnicity As Collected NOT HISPANIC OR LATINO A person not of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. An arbitrary ethnic classification. (NCI) Not Hispanic or Latino 95 | C43234 C128690 Ethnicity As Collected NOT REPORTED Not reported Not provided or available. Not Reported 96 | C158198 C128690 Ethnicity As Collected NU NU A Chinese person from the Nu ethnic group. Nu Chinese 97 | C158208 C128690 Ethnicity As Collected OROQEN OR A Chinese person from the Oroqen ethnic group. Oroqen Chinese 98 | C67112 C128690 Ethnicity As Collected PUERTO RICAN A person of Puerto Rican descent. Puerto Rican 99 | C158196 C128690 Ethnicity As Collected PUMI PM A Chinese person from the Pumi ethnic group. Pumi Chinese 100 | C158185 C128690 Ethnicity As Collected QIANG QI A Chinese person from the Qiang ethnic group. Qiang Chinese 101 | C158204 C128690 Ethnicity As Collected RUSS RS A Chinese person from the Russ ethnic group. Russ Chinese 102 | C158192 C128690 Ethnicity As Collected SALAR SL A Chinese person from the Salar ethnic group. Salar Chinese 103 | C103283 C128690 Ethnicity As Collected SEPHARDIC JEW A person of Sephardic Jewish descent. Sephardic Jew 104 | C158177 C128690 Ethnicity As Collected SHE SH A Chinese person from the She ethnic group. She Chinese 105 | C126532 C128690 Ethnicity As Collected SOUTH AMERICAN A person of South American descent. South American 106 | C67120 C128690 Ethnicity As Collected SPANISH A person from Spain or of Spanish descent. Spanish 107 | C158183 C128690 Ethnicity As Collected SUI SU A Chinese person from the Sui ethnic group. Sui Chinese 108 | C158195 C128690 Ethnicity As Collected TAJIK TA A Chinese person from the Tajik ethnic group. Tajik Chinese 109 | C158213 C128690 Ethnicity As Collected TATAR TT A Chinese person from the Tatar ethnic group. Tatar Chinese 110 | C158186 C128690 Ethnicity As Collected TU TU A Chinese person from the Tu ethnic group. Tu Chinese 111 | C158165 C128690 Ethnicity As Collected TUJIA TJ A Chinese person from the Tujia ethnic group. Tujia Chinese 112 | C17998 C128690 Ethnicity As Collected UNKNOWN U; UNK; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown 113 | C158162 C128690 Ethnicity As Collected UYGUR UG A Chinese person from the Uygur ethnic group. Uygur Chinese 114 | C158206 C128690 Ethnicity As Collected UZBEK UZ A Chinese person from the Uzbek ethnic group. Uzbek Chinese 115 | C158182 C128690 Ethnicity As Collected VA VA A Chinese person from the Va ethnic group. Va Chinese 116 | C158188 C128690 Ethnicity As Collected XIBE XB A Chinese person from the Xibe ethnic group. Xibe Chinese 117 | C158170 C128690 Ethnicity As Collected YAO YA A Chinese person from the Yao ethnic group. Yao Chinese 118 | C158164 C128690 Ethnicity As Collected YI YI A Chinese person from the Yi ethnic group. Yi Chinese 119 | C158205 C128690 Ethnicity As Collected YUGUR YG A Chinese person from the Yugur ethnic group. Yugur Chinese 120 | C158166 C128690 Ethnicity As Collected ZANG ZA A Chinese person from the Zang (including Amdowa, Khampa and some Pumi speakers) ethnic group. Zang Chinese 121 | C158159 C128690 Ethnicity As Collected ZHUANG ZH A Chinese person from the Zhuang ethnic group. Zhuang Chinese 122 | C78426 Yes Exposure Dose Form EXDOSFRM Exposure Dose Form A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Exposure Dose Form codelist. (NCI) CDISC CDASH Exposure Dose Form Terminology 123 | C42887 C78426 Exposure Dose Form AEROSOL aer A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). Aerosol Dosage Form 124 | C25158 C78426 Exposure Dose Form CAPSULE cap A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI) Capsule Dosage Form 125 | C28944 C78426 Exposure Dose Form CREAM A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Cream Dosage Form 126 | C42933 C78426 Exposure Dose Form GAS Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) Gas Dosage Form 127 | C42934 C78426 Exposure Dose Form GEL A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. Gel Dosage Form 128 | C42966 C78426 Exposure Dose Form OINTMENT oint A suspension or emulsion, semisolid (1) dosage form, usually containing less than 20 percent water and volatiles (2) and greater than 50 percent hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. Ointment Dosage Form 129 | C42968 C78426 Exposure Dose Form PATCH A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. Patch Dosage Form 130 | C42972 C78426 Exposure Dose Form POWDER An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) Powder Dosage Form 131 | C42989 C78426 Exposure Dose Form SPRAY A liquid minutely divided as by a jet of air or steam. (NCI) Spray Dosage Form 132 | C42993 C78426 Exposure Dose Form SUPPOSITORY supp A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature. Suppository Dosage Form 133 | C42994 C78426 Exposure Dose Form SUSPENSION Ready to Use Suspension; susp A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Suspension Dosage Form 134 | C42998 C78426 Exposure Dose Form TABLET tab A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Tablet Dosage Form 135 | C78745 Yes Exposure Dosing Frequency per Interval EXDOSFRQ Exposure Dosing Frequency per Interval A terminology subset of the CDISC SDTM Frequency codelist created for CDASH Exposure Dosing Frequency per Interval codelist. (NCI) CDISC CDASH Exposure Dosing Frequency per Interval Terminology 136 | C64496 C78745 Exposure Dosing Frequency per Interval BID BD; Twice per day Two times per day, at unspecified times. (NCI) Twice Daily 137 | C64499 C78745 Exposure Dosing Frequency per Interval PRN As needed As needed. (NCI) As Needed 138 | C25473 C78745 Exposure Dosing Frequency per Interval QD /day; Daily; Per Day A rate of occurrences within a period of time equal to one day. Daily 139 | C64530 C78745 Exposure Dosing Frequency per Interval QID 4 times per day Four times per day. (NCI) Four Times Daily 140 | C64498 C78745 Exposure Dosing Frequency per Interval QM Every Month; Per Month Every month. (NCI) Monthly 141 | C64525 C78745 Exposure Dosing Frequency per Interval QOD Every other day; Every Second Day; Every Two Days; Q2D Every other day. (NCI) Every Other Day 142 | C64527 C78745 Exposure Dosing Frequency per Interval TID 3 times per day Three times per day. (NCI) Three Times Daily 143 | C17998 C78745 Exposure Dosing Frequency per Interval UNKNOWN U; UNK; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown 144 | C78425 Yes Exposure Route of Administration EXROUTE Exposure Route of Administration A terminology subset of the CDISC SDTM Route codelist created for CDASH Exposure Route of Administration codelist. (NCI) CDISC CDASH Exposure Route of Administration Terminology 145 | C38250 C78425 Exposure Route of Administration INTRALESIONAL Administration within or introduced directly into a localized lesion. (FDA) Intralesional Route of Administration 146 | C28161 C78425 Exposure Route of Administration INTRAMUSCULAR Administration within a muscle. (FDA) Intramuscular Route of Administration 147 | C38255 C78425 Exposure Route of Administration INTRAOCULAR Administration within the eye. (FDA) Intraocular Route of Administration 148 | C38258 C78425 Exposure Route of Administration INTRAPERITONEAL Administration within the peritoneal cavity. (FDA) Intraperitoneal Route of Administration 149 | C38284 C78425 Exposure Route of Administration NASAL Intranasal Route of Administration Administration to the nose; administered by way of the nose. (FDA) Nasal Route of Administration 150 | C38288 C78425 Exposure Route of Administration ORAL Intraoral Route of Administration; PO Administration to or by way of the mouth. (FDA) Oral Route of Administration 151 | C38295 C78425 Exposure Route of Administration RECTAL Administration to the rectum. (FDA) Rectal Route of Administration 152 | C38216 C78425 Exposure Route of Administration RESPIRATORY (INHALATION) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) Inhalation Route of Administration 153 | C38299 C78425 Exposure Route of Administration SUBCUTANEOUS SC; Subdermal Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) Subcutaneous Route of Administration 154 | C38304 C78425 Exposure Route of Administration TOPICAL TOP Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. (FDA) Topical Route of Administration 155 | C38305 C78425 Exposure Route of Administration TRANSDERMAL Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Transdermal Route of Administration 156 | C38313 C78425 Exposure Route of Administration VAGINAL Administration into the vagina. (FDA) Vaginal Route of Administration 157 | C181165 Yes Mode of Delivery MODDLV Mode of Delivery A terminology codelist relevant to the mode of delivery of a fetus or neonate. CDISC SDTM Mode of Delivery Terminology 158 | C114136 C181165 Mode of Delivery BREECH EXTRACTION The delivery of a breech-presenting fetus, which is manually pulled through the birth canal. Breech Extraction 159 | C46088 C181165 Mode of Delivery CESAREAN SECTION Surgical delivery of one or more intrauterine fetuses though an abdominal incision. Cesarean Section 160 | C114143 C181165 Mode of Delivery DELIVERY BY DESTRUCTIVE OPERATION Extraction of a fetus through the cervix using destructive surgical techniques. Delivery by Destructive Operation 161 | C81301 C181165 Mode of Delivery VAGINAL ASSISTED DELIVERY Operative Vaginal Delivery Birth of the fetus through the vagina with the application of vacuum or forceps or any other instrument. Vaginal Assisted Delivery 162 | C81302 C181165 Mode of Delivery VAGINAL BIRTH AFTER CESAREAN DELIVERY A vaginal birth in a woman with one or more previous cesarean births. (reVITALize) Vaginal Birth after Cesarean Delivery 163 | C81303 C181165 Mode of Delivery VAGINAL DELIVERY Birth of the fetus through the vagina. Vaginal Delivery 164 | C128689 Yes Race As Collected RACEC Race As Collected A terminology codelist relevant to the race of an individual as collected on the case report form. CDISC SDTM Collected Race Terminology 165 | C154875 C128689 Race As Collected ABORIGINAL AUSTRALIAN The native people of Australia. Aboriginal Australian 166 | C128937 C128689 Race As Collected AFRICAN AMERICAN A person having origins in the original peoples of sub-Saharan Africa and the United States. African American 167 | C41226 C128689 Race As Collected AFRICAN CARIBBEAN A person having origins in the original peoples of sub-Saharan Africa and the Caribbean. African Caribbean 168 | C42331 C128689 Race As Collected AFRICAN A person having origins in any of the original peoples of sub-Saharan Africa. African 169 | C18237 C128689 Race As Collected ALASKA NATIVE The native people of Alaska. Alaska Native 170 | C41259 C128689 Race As Collected AMERICAN INDIAN OR ALASKA NATIVE A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment. (FDA) American Indian or Alaska Native 171 | C43877 C128689 Race As Collected AMERICAN INDIAN The native people of North America. American Indian 172 | C43876 C128689 Race As Collected ARAB A person having origins in any of the original peoples of the Arabian peninsula and surrounding territories in the Middle East and northern Africa. Arab 173 | C16310 C128689 Race As Collected ASIAN AMERICAN A person having origins in the original peoples of Asia and the United States. Asian American 174 | C41262 C128689 Race As Collected ASIAN INDIAN A person having origins in any of the original peoples of the Indian subcontinent. Asian Indian 175 | C41260 C128689 Race As Collected ASIAN A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (FDA) Asian 176 | C67271 C128689 Race As Collected BAHAMIAN A person having origins in any of the original peoples of the Bahamas. Bahamian 177 | C43671 C128689 Race As Collected BANGLADESHI A person having origins in any of the original peoples of Bangladesh. Bangladeshi 178 | C43823 C128689 Race As Collected BARBADIAN A person having origins in any of the original peoples of Barbados. Barbadian 179 | C43673 C128689 Race As Collected BHUTANESE A person having origins in any of the original peoples of Bhutan. Bhutanese 180 | C128991 C128689 Race As Collected BLACK CENTRAL AMERICAN A person having origins in the original peoples of sub-Saharan Africa and Central America. Black Central American 181 | C16352 C128689 Race As Collected BLACK OR AFRICAN AMERICAN A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American." (FDA) Black or African American 182 | C128992 C128689 Race As Collected BLACK SOUTH AMERICAN A person having origins in the original peoples of sub-Saharan Africa and South America. Black South American 183 | C128938 C128689 Race As Collected BLACK A person having origins in the original peoples of sub-Saharan Africa or the Caribbean. Black 184 | C43830 C128689 Race As Collected BOTSWANAN A person having origins in any of the original peoples of Botswana. Botswanan 185 | C43674 C128689 Race As Collected BURMESE A person having origins in any of the original peoples of Myanmar (formerly Burma). Burmese 186 | C43399 C128689 Race As Collected CAMBODIAN A person having origins in any of the original peoples of Cambodia (formerly Kampuchea). Cambodian 187 | C77810 C128689 Race As Collected CARIBBEAN INDIAN The native people of the Caribbean. Caribbean Indian 188 | C44950 C128689 Race As Collected CENTRAL AMERICAN INDIAN The native people of Central America. Central American Indian 189 | C126534 C128689 Race As Collected CENTRAL ASIAN A person having origins in any of the original peoples of Central Asia. Central Asian 190 | C43403 C128689 Race As Collected CHAMORRO The native people of the Mariana Islands, including the United States territories of Guam and the Commonwealth of the Northern Mariana Islands in Micronesia. Chamorran 191 | C43391 C128689 Race As Collected CHINESE A person having origins in any of the original peoples of China. Chinese 192 | C43824 C128689 Race As Collected DOMINICA ISLANDER A person having origins in any of the original peoples of Dominica. Dominica Islander 193 | C67117 C128689 Race As Collected DOMINICAN A person having origins in any of the original peoples of the Dominican Republic. Dominican 194 | C161419 C128689 Race As Collected EAST ASIAN A person having origins in any of the original peoples of East Asia. East Asian 195 | C77819 C128689 Race As Collected EASTERN EUROPEAN A person having origins in any of the original peoples of Eastern Europe. Eastern European 196 | C43831 C128689 Race As Collected ETHIOPIAN A person having origins in any of the original peoples of Ethiopia. Ethiopian 197 | C43851 C128689 Race As Collected EUROPEAN A person having origins in any of the original peoples of Europe. European 198 | C43393 C128689 Race As Collected FILIPINO A person having origins in any of the original peoples of the Philippines. Filipino 199 | C44265 C128689 Race As Collected GREENLAND INUIT The native people of Greenland. Greenland Eskimo 200 | C43837 C128689 Race As Collected GUAMANIAN OR CHAMORRO A person having origins in the original peoples of the United States territories of Guam and the Commonwealth of the Northern Mariana Islands in Micronesia. Guamanian or Chamorro 201 | C43404 C128689 Race As Collected GUAMANIAN A person having origins in any of the original peoples of Guam. Guamanian 202 | C43825 C128689 Race As Collected HAITIAN A person having origins in any of the original peoples of Haiti. Haitian 203 | C43398 C128689 Race As Collected HMONG The native people originating in China around the Yellow River or Hoang Ho. Hmong 204 | C43715 C128689 Race As Collected INDONESIAN A person having origins in any of the original peoples of Indonesia. Indonesian 205 | C44268 C128689 Race As Collected INUPIAT INUIT The native people inhabiting the territory spanning the Norton Sound on the Bering Sea to the Canadian border. Inupiat Eskimo 206 | C43718 C128689 Race As Collected IWO JIMAN A person having origins in any of the original peoples of Iwo Jima. Iwo Jiman 207 | C43826 C128689 Race As Collected JAMAICAN A person having origins in any of the original peoples of Jamaica. Jamaican 208 | C43392 C128689 Race As Collected JAPANESE A person having origins in any of the original peoples of Japan. Japanese 209 | C154874 C128689 Race As Collected KHOISAN The native people of the Western Cape in southern Africa. Khoisan 210 | C43395 C128689 Race As Collected KOREAN A person having origins in any of the original peoples of North and South Korea. Korean 211 | C43397 C128689 Race As Collected LAOTIAN A person having origins in any of the original peoples of Laos. Laotian 212 | C126531 C128689 Race As Collected LATIN AMERICAN A person of Latin American descent. Latin American 213 | C43832 C128689 Race As Collected LIBERIAN A person having origins in any of the original peoples of Liberia. Liberian 214 | C43722 C128689 Race As Collected MALAGASY A person having origins in any of the original peoples of Madagascar. Malagasy 215 | C43716 C128689 Race As Collected MALAYSIAN A person having origins in any of the original peoples of Malaysia. Malaysian 216 | C43719 C128689 Race As Collected MALDIVIAN A person having origins in any of the original peoples of the Maldives. Maldivian 217 | C158274 C128689 Race As Collected MAORI The native people of New Zealand. Maori 218 | C77811 C128689 Race As Collected MEDITERRANEAN A person having origins in any of the original peoples of the countries surrounding the Mediterranean sea. Mediterranean 219 | C43409 C128689 Race As Collected MELANESIAN A person having origins in any of the original peoples of Melanesia. Melanesian 220 | C43402 C128689 Race As Collected MICRONESIAN A person having origins in any of the original peoples of Micronesia. Micronesian 221 | C77820 C128689 Race As Collected MIDDLE EASTERN A person having origins in any of the original peoples of the Middle East. Middle Eastern 222 | C43864 C128689 Race As Collected MONGOLIAN A person having origins in any of the original peoples of Mongolia. Mongolian 223 | C43833 C128689 Race As Collected NAMIBIAN A person having origins in any of the original peoples of Namibia. Namibian 224 | C41219 C128689 Race As Collected NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER Denotes a person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. The term covers particularly people who identify themselves as part-Hawaiian, Native Hawaiian, Guamanian or Chamorro, Carolinian, Samoan, Chuu. (FDA) Native Hawaiian or Other Pacific Islander 225 | C43394 C128689 Race As Collected NATIVE HAWAIIAN A person having origins in any of the original peoples of Hawaii. (NCI) Native Hawaiian 226 | C43720 C128689 Race As Collected NEPALESE A person having origins in any of the original peoples of Nepal. Nepalese 227 | C43834 C128689 Race As Collected NIGERIAN A person having origins in any of the original peoples of Nigeria. Nigerian 228 | C77813 C128689 Race As Collected NORTH AFRICAN A person having origins in any of the original peoples of North Africa. North Coast of Africa 229 | C77814 C128689 Race As Collected NORTHERN EUROPEAN A person having origins in any of the original peoples of Northern Europe. Northern European 230 | C43234 C128689 Race As Collected NOT REPORTED Not reported Not provided or available. Not Reported 231 | C43717 C128689 Race As Collected OKINAWAN A person having origins in any of the original peoples of Okinawa. Okinawan 232 | C107602 C128689 Race As Collected OTHER PACIFIC ISLANDER A person having origins in the original peoples of the Pacific Islands, but not Guam, Hawaii, the Mariana Islands or Samoa. (NCI) Other Pacific Islander 233 | C43427 C128689 Race As Collected PAKISTANI A person having origins in any of the original peoples of Pakistan. Pakistani 234 | C43405 C128689 Race As Collected POLYNESIAN A person having origins in any of the original peoples of Polynesia. Polynesian 235 | C43860 C128689 Race As Collected RUSSIAN A person having origins in any of the original peoples of Russia. Russian 236 | C43407 C128689 Race As Collected SAMOAN A person having origins in any of the original peoples of Samoa. (NCI) Samoan 237 | C44269 C128689 Race As Collected SIBERIAN ESKIMO The native Yupik people inhabiting the coast of the Chukchi Peninsula in the far northeast of the Russian Federation and on St. Lawrence Island in Alaska. Siberian Eskimo 238 | C43721 C128689 Race As Collected SINGAPOREAN A person having origins in any of the original peoples of Singapore. Singaporean 239 | C44953 C128689 Race As Collected SOUTH AMERICAN INDIAN The native people of South America. South American Indian 240 | C41263 C128689 Race As Collected SOUTH ASIAN A person having origins in any of the original peoples of the South Asia. South Asian 241 | C126533 C128689 Race As Collected SOUTHEAST ASIAN A person having origins in any of the original peoples of Southeast Asia. Southeast Asian 242 | C156583 C128689 Race As Collected SOUTHERN AFRICAN COLOURED A person of mixed race, whose ancestry is from one or more of the naturalized racial groups of Southern Africa (typically Western European, South Asian, or Southeastern Asian) and one or more of the indigenous Southern African peoples. Southern African Coloured 243 | C43672 C128689 Race As Collected SRI LANKAN A person having origins in any of the original peoples of Sri Lanka. Sri Lankan 244 | C43675 C128689 Race As Collected TAIWANESE A person having origins in any of the original peoples of Taiwan. Taiwanese 245 | C43400 C128689 Race As Collected THAI A person having origins in any of the original peoples of Thailand. Thai 246 | C43827 C128689 Race As Collected TOBAGOAN A person having origins in any of the original peoples of Tobago. Tobagoan 247 | C43828 C128689 Race As Collected TRINIDADIAN A person having origins in any of the original peoples of Trinidad. Trinidadian 248 | C17998 C128689 Race As Collected UNKNOWN U; UNK; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown 249 | C43396 C128689 Race As Collected VIETNAMESE A person having origins in any of the original peoples of Viet Nam. Vietnamese 250 | C153343 C128689 Race As Collected WEST ASIAN A person having origins in any of the original peoples of Western Asia. Western Asian 251 | C43829 C128689 Race As Collected WEST INDIAN A person having origins in any of the original peoples of the West Indies. West Indian 252 | C77817 C128689 Race As Collected WESTERN EUROPEAN A person having origins in any of the original peoples of Western Europe. Western European 253 | C77816 C128689 Race As Collected WHITE CARIBBEAN A person having origins in the original peoples of Europe, the Middle East, or North Africa, and the Caribbean. White Caribbean 254 | C128993 C128689 Race As Collected WHITE CENTRAL AMERICAN A person having origins in the original peoples of Europe, the Middle East, or North Africa, and Central America. White Central American 255 | C128994 C128689 Race As Collected WHITE SOUTH AMERICAN A person having origins in the original peoples of Europe, the Middle East, or North Africa, and South America. White South American 256 | C41261 C128689 Race As Collected WHITE Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White. (FDA) White 257 | C44270 C128689 Race As Collected YUPIK ESKIMO The native people inhabiting western, southwestern, and southcentral Alaska and the Russian Far East. Yupik Eskimo 258 | C43835 C128689 Race As Collected ZAIREAN A person having origins in any of the original peoples of Zaire. Zairean 259 | C177909 No Serious Adverse Event Report Category SAERCAT Serious Adverse Event Report Category Terminology relevant to the classification of a serious adverse event report. CDISC CDASH Serious Adverse Event Report Category Response Terminology 260 | C41200 C177909 Serious Adverse Event Report Category AMENDMENT Amended Action(s) undertaken to modify by means of correction, addition, subtraction, or replacement. Amendment 261 | C178052 C177909 Serious Adverse Event Report Category NULLIFICATION Nullified Action(s) undertaken to void, negate, or invalidate. Nullification 262 | C25604 C177909 Serious Adverse Event Report Category ORIGINAL Preceding all others in time or being as first made or performed. Original 263 | C181164 Yes Study Agent Dechallenge Reaction Response SADCRR Study Agent Dechallenge Reaction Response A terminology codelist relevant to the resultant reaction due to withdrawing, interrupting, or otherwise altering administration of study treatment. CDISC CDASH Study Agent Dechallenge Reaction Response Terminology 264 | C181222 C181164 Study Agent Dechallenge Reaction Response NEGATIVE DECHALLENGE Continued presence of an adverse event after decrease or change in dose, or withdrawal of the product/drug. Negative Dechallenge Response 265 | C181224 C181164 Study Agent Dechallenge Reaction Response NOT APPLICABLE DECHALLENGE The outcome of decreasing the dose or discontinuation of the product/drug is not relevant in the current context. Not Applicable Dechallenge Response 266 | C181223 C181164 Study Agent Dechallenge Reaction Response POSITIVE DECHALLENGE Partial or complete abatement of an adverse event after decrease or change in dose, or withdrawal of the product/drug. Positive Dechallenge Response 267 | C181225 C181164 Study Agent Dechallenge Reaction Response UNKNOWN DECHALLENGE No information regarding the outcome of decreasing the dose or discontinuation of the product/drug. Unknown Dechallenge Response 268 | C181163 Yes Study Agent Rechallenge Reaction Response SARCRR Study Agent Rechallenge Reaction Response A terminology codelist relevant to the resultant reaction due to restarting or otherwise returning administration of study treatment to previous level, after a dechallenge event. CDISC CDASH Study Agent Rechallenge Reaction Response Terminology 269 | C181226 C181163 Study Agent Rechallenge Reaction Response NEGATIVE RECHALLENGE Failure of the product/drug, when reintroduced, to produce signs or symptoms similar to those observed when the product/drug was previously used. Negative Rechallenge Response 270 | C181228 C181163 Study Agent Rechallenge Reaction Response NOT APPLICABLE RECHALLENGE The outcome of reintroduction of product/drug is not relevant in the current context. Not Applicable Rechallenge Response 271 | C181227 C181163 Study Agent Rechallenge Reaction Response POSITIVE RECHALLENGE Recurrence of similar or new signs and symptoms upon reintroduction of the product/drug. Positive Rechallenge Response 272 | C181229 C181163 Study Agent Rechallenge Reaction Response UKNOWN RECHALLENGE No information regarding the outcome of reintroduction of product/drug. Unknown Rechallenge Response 273 | C83004 Yes Substance Use Never/Current/Former Classification SUNCF Substance Use Never/Current/Former Classification A terminology subset of the CDISC SDTM Never/Current/Former Classification codelist created for CDASH Substance Use Never/Current/Former Classification codelist. (NCI) CDISC CDASH Substance Use Never/Current/Former Classification Terminology 274 | C25471 C83004 Substance Use Never/Current/Former Classification CURRENT Occurring in or belonging to the present time. (NCI) Current 275 | C25627 C83004 Substance Use Never/Current/Former Classification FORMER Previous Occurring prior to something else. (NCI) Previous 276 | C70543 C83004 Substance Use Never/Current/Former Classification NEVER Not ever; at no time in the past. Never 277 | C78428 Yes Total Volume Administration Unit EXVOLTU Total Volume Administration Unit A terminology subset of the CDISC SDTM Unit codelist created for CDASH Total Volume Administration Unit codelist. (NCI) CDISC CDASH Total Volume Administration Unit Terminology 278 | C28253 C78428 Total Volume Administration Unit mg Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram 279 | C28254 C78428 Total Volume Administration Unit mL cm3; Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter 280 | C48152 C78428 Total Volume Administration Unit ug mcg; Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram 281 | C78427 Yes Unit for the Duration of Treatment Interruption EXINTPU Unit for the Duration of Treatment Interruption A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit for Duration of Treatment Interruption codelist. (NCI) CDISC CDASH Unit for Duration of Treatment Interruption Terminology 282 | C25529 C78427 Unit for the Duration of Treatment Interruption HOURS h; Hours; hr A unit of measurement of time equal to 60 minutes. Hour 283 | C48154 C78427 Unit for the Duration of Treatment Interruption min Minute A unit of measurement of time equal to 60 seconds. Minute 284 | C42535 C78427 Unit for the Duration of Treatment Interruption sec Second The base unit of time in the International System of Units (SI) equal to the duration of 9,192,631,770 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. Second 285 | C78421 Yes Unit of Drug Dispensed or Returned DAORRESU Unit of Drug Dispensed or Returned A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Drug Dispensed or Returned codelist. (NCI) CDISC CDASH Unit of Drug Dispensed or Returned Terminology 286 | C48474 C78421 Unit of Drug Dispensed or Returned BAG Bag Dosing Unit A dosing measurement based on the bag unit.(NCI) Bag Dosing Unit 287 | C48477 C78421 Unit of Drug Dispensed or Returned BOTTLE Bottle Dosing Unit A dosing measurement based on the bottle unit.(NCI) Bottle Dosing Unit 288 | C48478 C78421 Unit of Drug Dispensed or Returned BOX Box Dosing Unit A dosing measurement based on the box unit.(NCI) Box Dosing Unit 289 | C48480 C78421 Unit of Drug Dispensed or Returned CAPSULE cap; Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit 290 | C48484 C78421 Unit of Drug Dispensed or Returned CONTAINER Container Dosing Unit A dosing measurement based on the container unit.(NCI) Container Dosing Unit 291 | C48490 C78421 Unit of Drug Dispensed or Returned DISK Disk Dosing Unit A dosing measurement based on the disk unit.(NCI) Disk Dosing Unit 292 | C48520 C78421 Unit of Drug Dispensed or Returned PACKAGE Pack Dosing Unit; Package Dosing Unit A dosing measurement based on the package unit.(NCI) Package Dosing Unit 293 | C48521 C78421 Unit of Drug Dispensed or Returned PACKET Packet Dosing Unit A dosing measurement based on the packet unit.(NCI) Packet Dosing Unit 294 | C48524 C78421 Unit of Drug Dispensed or Returned PATCH Patch Dosing Unit A dosing measurement based on the patch unit.(NCI) Patch Dosing Unit 295 | C48542 C78421 Unit of Drug Dispensed or Returned TABLET tab; Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit 296 | C48549 C78421 Unit of Drug Dispensed or Returned TUBE Tube Dosing Unit A dosing measurement based on the tube unit.(NCI) Tube Dosing Unit 297 | C48551 C78421 Unit of Drug Dispensed or Returned VIAL Vial Dosing Unit A dosing measurement based on the vial unit.(NCI) Vial Dosing Unit 298 | C78429 Yes Unit of Measure for Flow Rate EXFLRTU Unit of Measure for Flow Rate A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Measure for Flow Rate codelist. (NCI) CDISC CDASH Unit of Measure for Flow Rate Terminology 299 | C64777 C78429 Unit of Measure for Flow Rate mL/min A unit of flow rate equal to one milliliter per minute. Milliliter per Minute 300 | C67420 C78429 Unit of Measure for Flow Rate mmol/day mmol/24h A unit of substance flow rate equal to one millimole per day. Millimole per 24 Hours 301 | C71205 C78429 Unit of Measure for Flow Rate ug/day mcg/day A unit of mass flow rate equal to one microgram per day. Microgram per Day 302 | C71211 C78429 Unit of Measure for Flow Rate ug/min mcg/min A unit of mass flow rate equal to one microgram per minute. Microgram per Minute 303 | C67406 C78429 Unit of Measure for Flow Rate umol/day mcmol/day A unit of substance flow rate equal to one micromole per day. Micromole per 24 Hours 304 | C78423 Yes Units for Exposure EXDOSU Units for Exposure A terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Exposure codelist. (NCI) CDISC CDASH Units for Exposure Terminology 305 | C48480 C78423 Units for Exposure CAPSULE cap; Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit 306 | C48155 C78423 Units for Exposure g Gram A unit of mass equal to one thousandth (1E-3) of a kilogram, the kilogram being the base unit of mass in the International System of Units (SI). Gram 307 | C28253 C78423 Units for Exposure mg Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram 308 | C28254 C78423 Units for Exposure mL cm3; Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter 309 | C65060 C78423 Units for Exposure PUFF Puff Dosing Unit A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) Puff Dosing Unit 310 | C48542 C78423 Units for Exposure TABLET tab; Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit 311 | C48152 C78423 Units for Exposure ug mcg; Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram 312 | C78430 Yes Units for Planned Exposure EXPDOSEU Units for Planned Exposure A terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Planned Exposure codelist. (NCI) CDISC CDASH Units for Planned Exposure Terminology 313 | C48480 C78430 Units for Planned Exposure CAPSULE cap; Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit 314 | C48155 C78430 Units for Planned Exposure g Gram A unit of mass equal to one thousandth (1E-3) of a kilogram, the kilogram being the base unit of mass in the International System of Units (SI). Gram 315 | C28253 C78430 Units for Planned Exposure mg Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram 316 | C28254 C78430 Units for Planned Exposure mL cm3; Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter 317 | C65060 C78430 Units for Planned Exposure PUFF Puff Dosing Unit A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) Puff Dosing Unit 318 | C48542 C78430 Units for Planned Exposure TABLET tab; Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit 319 | C48152 C78430 Units for Planned Exposure ug mcg; Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram 320 | C78431 Yes Vital Signs Position of Subject VSPOS Vital Signs Position of Subject A terminology subset of the CDISC SDTM Position codelist created for CDASH Vital Signs Position of Subject codelist. (NCI) CDISC CDASH Vital Signs Position of Subject Terminology 321 | C62122 C78431 Vital Signs Position of Subject SITTING Sitting The state or act of one who sits; the posture of one who occupies a seat. (NCI) Sitting 322 | C62166 C78431 Vital Signs Position of Subject STANDING Orthostatic; Standing The act of assuming or maintaining an erect upright position. (NCI) Standing 323 | C62167 C78431 Vital Signs Position of Subject SUPINE Supine A posterior recumbent body position whereby the person lies on its back and faces upward. (NCI) Supine Position 324 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/current/Define-XML Terminology.txt: -------------------------------------------------------------------------------- 1 | Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term 2 | C165635 No ADaM Basic Data Structure Subclass BDSSC ADaM Basic Data Structure Subclass Terminology relevant to the subclasses of the ADaM basic data structure. CDISC Define-XML ADaM Basic Data Structure Subclass Terminology 3 | C172452 C165635 ADaM Basic Data Structure Subclass NON-COMPARTMENTAL ANALYSIS NCA A dataset containing data that is used for non-compartmental analyses. Non-Compartmental Analysis Dataset 4 | C165637 C165635 ADaM Basic Data Structure Subclass TIME-TO-EVENT TTE A dataset containing data that is used for Time-to-Event analyses. Time-to-Event Dataset 5 | C177903 No ADaM Medical Device Basic Data Structure Subclass MDBDSSC ADaM Medical Device Basic Data Structure Subclass Terminology relevant to the subclasses of the ADaM device level basic data structure. CDISC Define-XML ADaM Medical Device Basic Data Structure Subclass Terminology 6 | C177920 C177903 ADaM Medical Device Basic Data Structure Subclass MEDICAL DEVICE TIME-TO-EVENT MDTTE A dataset containing data that is used for medical device Time-to-Event analyses. Medical Device Time-to-Event Dataset 7 | C176227 No ADaM Occurrence Data Structure Subclass OCCSC ADaM Occurrence Data Structure Subclass Terminology relevant to the subclasses of the ADaM occurrence data structure. CDISC Define-XML ADaM Occurrence Data Structure Subclass Terminology 8 | C176265 C176227 ADaM Occurrence Data Structure Subclass ADVERSE EVENT A dataset containing data that is used for adverse event analyses. Adverse Event Dataset 9 | C117745 Yes Analysis Purpose ANLPURP Analysis Purpose Purpose of a specific analysis result described in Define-XML analysis results metadata. CDISC Define-XML Analysis Purpose Terminology 10 | C98724 C117745 Analysis Purpose EXPLORATORY OUTCOME MEASURE Exploratory Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure 11 | C98772 C117745 Analysis Purpose PRIMARY OUTCOME MEASURE Primary Outcome Measure The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure 12 | C98781 C117745 Analysis Purpose SECONDARY OUTCOME MEASURE Secondary Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure 13 | C117744 Yes Analysis Reason ANLREAS Analysis Reason Reason for reporting a specific analysis result described in Define-XML analysis results metadata. CDISC Define-XML Analysis Reason Terminology 14 | C117750 C117744 Analysis Reason DATA DRIVEN The analysis was triggered by findings in the data. Data Driven Analysis 15 | C117751 C117744 Analysis Reason REQUESTED BY REGULATORY AGENCY The analysis has been requested by a regulatory agency. Analysis Requested by Regulatory Agency 16 | C117752 C117744 Analysis Reason SPECIFIED IN PROTOCOL The analysis is specified in a protocol. Analysis Specified in Protocol 17 | C117753 C117744 Analysis Reason SPECIFIED IN SAP The analysis is specified in a statistical analysis plan. Analysis Specified in Statistical Analysis Plan 18 | C172331 No CDISC Controlled Terminology Standard Type CTSTDTYP CDISC Controlled Terminology Standard Type Terminology relevant to the classification of the CDISC controlled terminology standard described in the Define-XML document. CDISC Define-XML CDISC Controlled Terminology Standard Type Terminology 19 | C180548 C172331 CDISC Controlled Terminology Standard Type ADaM The controlled terminology standard subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model (ADaM). CDISC ADaM Standard Terminology 20 | C180549 C172331 CDISC Controlled Terminology Standard Type CDASH The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Clinical Data Acquisition Standards Harmonization (CDASH) group. CDISC CDASH Standard Terminology 21 | C180550 C172331 CDISC Controlled Terminology Standard Type DEFINE-XML The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Define-XML standard. CDISC Define-XML Standard Terminology 22 | C180551 C172331 CDISC Controlled Terminology Standard Type SDTM The controlled terminology standard subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). CDISC SDTM Standard Terminology 23 | C180552 C172331 CDISC Controlled Terminology Standard Type SEND The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Non-clinical Data (SEND) group. CDISC SEND Standard Terminology 24 | C66788 Yes Dictionary Name DICTNAM Dictionary Name A name given to a reference source that lists words and gives their meaning. (NCI) CDISC Dictionary Name Terminology 25 | C163415 C66788 Dictionary Name CDISC CT CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology 26 | C49471 C66788 Dictionary Name COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms A terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI) Thesaurus of Adverse Reaction Term Coding Symbols 27 | C49704 C66788 Dictionary Name CTCAE Common Terminology Criteria for Adverse Events A standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. Common Terminology Criteria for Adverse Events 28 | C134003 C66788 Dictionary Name D-U-N-S NUMBER Data Universal Number System; DUNS Numbers A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. Data Universal Numbering System 29 | C49474 C66788 Dictionary Name ICD International Classification of Diseases A system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12) International Classification of Diseases 30 | C49476 C66788 Dictionary Name LOINC Logical Observation Identifiers Names and Codes Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI) Logical Observation Identifiers Names and Codes 31 | C163416 C66788 Dictionary Name MED-RT Medication Reference Terminology; NDF-RT A standard terminology developed and maintained by the Veterans Health Administration (VHA) that includes terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of medications. MED-RT incorporates terminology from RxNORM, MeSH, and SNOMED CT. Medication Reference Terminology 32 | C43820 C66788 Dictionary Name MedDRA Medical Dictionary for Regulatory Activities MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI) MedDRA 33 | C53489 C66788 Dictionary Name SNOMED Systematized Nomenclature of Medicine A multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI) Systematized Nomenclature of Medicine 34 | C163417 C66788 Dictionary Name UNII SRS-UNII; Substance Registration System-Unique Ingredient Identifier A standard terminology developed and maintained by the Department of Veterans Affairs/Veterans Health Administration designated federal collaborative Structured Product Labeling Interagency Expert Panel (SPLIEP). It contains terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of drug ingredients and food allergens. Substance Registration System-Unique Ingredient Identifier 35 | C154331 C66788 Dictionary Name WHO ATC CLASSIFICATION SYSTEM Anatomical Therapeutic Chemical Classification System A World Health Organization (WHO) classification system, developed and maintained by the WHO Collaborating Centre for Drug Statistics Methodology, for medicinal substances where active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological, and chemical properties. Anatomical Therapeutic Chemical Classification System 36 | C49468 C66788 Dictionary Name WHOART World Health Organization Adverse Reaction Terms A terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI) World Health Organization Adverse Reaction Terminology 37 | C49475 C66788 Dictionary Name WHODD WHODrug Global; World Health Organization Drug Dictionary A reference source of drugs and drug associated information maintained by the World Health Organization. (NCI) World Health Organization Drug Dictionary 38 | C103329 No General Observation Class GNRLOBSC General Observation Class Terminology related to the classification of a CDISC domain. CDISC Define-XML General Observation Class Terminology 39 | C103375 C103329 General Observation Class ADAM OTHER ADaM Other An analysis dataset that doesn't conform to a pre-defined ADaM dataset structure (e.g. ADSL, BDS or OCCDS). CDISC Other ADaM Dataset 40 | C103371 C103329 General Observation Class BASIC DATA STRUCTURE Basic Data Structure; BDS An ADaM BDS dataset contains one or more records per subject, per analysis parameter, per analysis time point. Variables include the value being analyzed (e.g., AVAL) and the description of the value being analyzed (e.g., PARAM). Other variables in the dataset provide more information about the value being analyzed (e.g., the subject identification) or describe and trace the derivation of it (e.g., DTYPE) or support the analysis of it (e.g., treatment variables, covariates). CDISC Basic Data Structure Dataset 41 | C177921 C103329 General Observation Class DEVICE LEVEL ANALYSIS DATASET ADDL; Device Level Analysis Dataset The Device-Level Analysis Dataset (ADDL) is a one-record-per-device or one-record-per-subject-per-device dataset which contains variables that describe device characteristics and timing, and group the devices for analysis. ADDL is the primary source for device-level variables included in other analysis datasets. CDISC Device Level Analysis Dataset 42 | C103372 C103329 General Observation Class EVENTS Events This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). CDISC Events Class 43 | C135396 C103329 General Observation Class FINDINGS ABOUT Findings About This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. CDISC Findings About Class 44 | C103373 C103329 General Observation Class FINDINGS Findings This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. CDISC Findings Class 45 | C103374 C103329 General Observation Class INTERVENTIONS Interventions This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). CDISC Interventions Class 46 | C177922 C103329 General Observation Class MEDICAL DEVICE BASIC DATA STRUCTURE MDBDS; Medical Device Basic Data Structure The Medical Device Basic Data Structure (MDBDS) supports the analysis needs by adding SPDEVID as a required key variable and USUBJID a conditionally required variable. See the BDS class for further details. CDISC Medical Device Basic Data Structure 47 | C177923 C103329 General Observation Class MEDICAL DEVICE OCCURRENCE DATA STRUCTURE MDOCCDS; Medical Device Occurrence Data Structure The Medical Device Occurrence Data Structure (MDOCCDS) supports the analysis needs by adding SPDEVID as a required identifier and allowing USUBJID be a conditionally required variable. See the OCCDS class for further details. CDISC Medical Device Occurrence Data Structure 48 | C123454 C103329 General Observation Class OCCURRENCE DATA STRUCTURE OCCDS; Occurrence Data Structure The Occurrence Data Structure (OCCDS) is the ADaM data structure for occurrence analysis. Occurrence analysis is the counting of subjects with a record or term, and often includes a structured hierarchy of dictionary coding categories. CDISC Occurrence Data Structure 49 | C103376 C103329 General Observation Class RELATIONSHIP Relationships This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets. CDISC Relationship Class 50 | C103377 C103329 General Observation Class SPECIAL PURPOSE Special Purpose; SPECIAL-PURPOSE This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV. CDISC Special Purpose Class 51 | C147271 C103329 General Observation Class STUDY REFERENCE Study Reference This special purpose SDTM class contains further descriptions of study-specific identifiers that will be used in subject based domains. CDISC Study Reference Class 52 | C103378 C103329 General Observation Class SUBJECT LEVEL ANALYSIS DATASET ADSL; Subject Level Analysis Dataset The Subject-Level Analysis Dataset (ADSL) is a one-record-per-subject dataset which contains variables that describe subject demographic characteristics and group the subjects for analysis. ADSL is the primary source for subject-level variables included in other analysis datasets such as population flags and treatment variables. CDISC Subject Level Analysis Dataset 53 | C103379 C103329 General Observation Class TRIAL DESIGN Trial Design This SDTM class describes the plan for the procedures to be followed in a clinical trial, including planned and actual timing of events, control group, method of allocating treatments, blinding methods, assignment of epochs that subjects pass through in the course of a trial. CDISC Trial Design Class 54 | C170448 No ODM Context ODMCNTX ODM Context Terminology relevant to the context in which the Define-XML document is used. CDISC Define-XML ODM Context Terminology 55 | C17649 C170448 ODM Context Other Other Different than the one(s) previously specified or mentioned. (NCI) Other 56 | C70885 C170448 ODM Context Submission An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness. Regulatory Submission 57 | C170450 No Origin Source ORIGINS Origin Source Terminology relevant to the origin source for datasets in the Define-XML document. CDISC Define-XML Origin Source Terminology 58 | C25936 C170450 Origin Source Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principal investigator. Investigator 59 | C70793 C170450 Origin Source Sponsor Clinical Study Sponsor; Sponsor; Study Sponsor An entity that is responsible for the initiation, management, and/or financing of a clinical study. Clinical Study Sponsor 60 | C41189 C170450 Origin Source Subject An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. Study Subject 61 | C68608 C170450 Origin Source Vendor A person or agency that promotes or exchanges goods or services for money. (NCI) Vendor 62 | C170449 No Origin Type ORIGINT Origin Type Terminology relevant to the origin type for datasets in the Define-XML document. CDISC Define-XML Origin Type Terminology 63 | C170547 C170449 Origin Type Assigned A value that is derived through designation, such as values from a look up table or a label on a CRF. Assigned Value 64 | C170548 C170449 Origin Type Collected A value that is actually observed and recorded by a person or obtained by an instrument. Collected Value 65 | C170549 C170449 Origin Type Derived A value that is calculated by an algorithm or reproducible rule, and which is dependent upon other data values. Derived Value 66 | C126101 C170449 Origin Type Not Available A value that is not discoverable or accessible. Not Available 67 | C17649 C170449 Origin Type Other Other Different than the one(s) previously specified or mentioned. (NCI) Other 68 | C170550 C170449 Origin Type Predecessor A value that is copied from a variable in another dataset. Copied Value 69 | C170551 C170449 Origin Type Protocol A value that is included as part of the study protocol. Protocol Value 70 | C170452 No Standard Name STDNAM Standard Name Terminology relevant to the name of the standard described in the Define-XML document. CDISC Define-XML Standard Name Terminology 71 | C170552 C170452 Standard Name ADaMIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard. ADaM Implementation Guide 72 | C163415 C170452 Standard Name CDISC/NCI CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology 73 | C170455 C170452 Standard Name SDTMIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model standard. SDTM Implementation Guide 74 | C170553 C170452 Standard Name SDTMIG-AP The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Associated Persons standard. SDTM Implementation Guide-Associated Persons 75 | C170554 C170452 Standard Name SDTMIG-MD The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Medical Devices standard. SDTM Implementation Guide-Medical Devices 76 | C170456 C170452 Standard Name SENDIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data standard. SEND Implementation Guide 77 | C181230 C170452 Standard Name SENDIG-AR The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Animal Rule standard. SEND Implementation Guide-Animal Rule 78 | C170556 C170452 Standard Name SENDIG-DART The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Developmental and Reproductive Toxicology standard. SEND Implementation Guide-Developmental and Reproductive Toxicology 79 | C172332 Yes Standard Status STDSTAT Standard Status Terminology relevant to the development or publication status of the standard. CDISC Define-XML Standard Status Terminology 80 | C172453 C172332 Standard Status DRAFT A preliminary version of a CDISC standard that has not yet completed the CDISC standards development process. (NCI) CDISC Draft Standard 81 | C172455 C172332 Standard Status FINAL A final version of a CDISC standard that has completed the CDISC standards development process. (NCI) CDISC Final Standard 82 | C172454 C172332 Standard Status PROVISIONAL A version of a CDISC standard whose conclusiveness is dependent upon the fulfillment of some contingency or final alteration. (NCI) CDISC Provisional Standard 83 | C170451 No Standard Type STDTYP Standard Type Terminology relevant to the classification of the standard described in the Define-XML document. CDISC Define-XML Standard Type Terminology 84 | C163415 C170451 Standard Type CT CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology 85 | C170454 C170451 Standard Type IG CDISC Implementation Guide A standard document developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) that contains instructions and requirements for the organization, structure, and format of standard clinical and non-clinical trial tabulation and analysis datasets. CDISC Implementation Guide 86 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/ADaM Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/CDASH Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/Define-XML Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/Glossary Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/Protocol Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | 2022-03-25 Add C142444 Term Protocol Entity Terminology Protocol Entity Terminology Add new term to existing codelist - - - Study Subject Discontinuation 3 | 2022-03-25 Add C142738 Term Protocol Entity Terminology Protocol Entity Terminology Add new term to existing codelist - - - Subject Replacement 4 | 2022-03-25 Add C185851 CDISC Codelist Study Subject Discontinuation Attribute Terminology Study Subject Discontinuation Attribute Terminology Addition of new codelist - - - Study Subject Discontinuation Attribute Terminology 5 | 2022-03-25 Add C49627 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Reason for Study Discontinuation 6 | 2022-03-25 Add C49634 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - PROT-Attr Subject Replacement 7 | 2022-03-25 Add C185850 CDISC Codelist Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Addition of new codelist - - - Subject Replacement Attribute Terminology 8 | 2022-03-25 Add C185956 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Conditions of Subject Withdrawal 9 | 2022-03-25 Add C185957 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Follow-up for Withdrawn Subject 10 | 2022-03-25 Add C185958 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Lost to Follow-up Criteria 11 | 2022-03-25 Add C185959 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Reason for Subject Withdrawal from Study 12 | 2022-03-25 Add C185960 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Study Subject Discontinuation Criteria 13 | 2022-03-25 Add C185961 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Subject Discontinuation Process 14 | 2022-03-25 Add C185962 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Subject Replacement Criteria 15 | 2022-03-25 Add C185963 Term Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Add new term to new codelist - - - Subject Replacement Statement 16 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/QRS Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | 2022-03-25 Update C100772 CDISC Definition QSCAT Category of Questionnaire Update CDISC Definition Neuropsychiatric Inventory (NPI) (copyright JL Cummings, 1994, all rights reserved; permission for commercial use required; npiTEST.net). Neuropsychiatric Inventory (NPI) (copyright JL Cummings, 1994, all rights reserved; permission for commercial use required; npiTEST.net). No part of the NPI may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the JL Cummings and payment of any applicable fees. Copyright JL Cummings, 1994, all rights reserved. 3 | 2022-03-25 Update C100772 NCI Preferred Term QSCAT Category of Questionnaire Update NCI Preferred Term Neuropsychiatric Inventory Questionnaire Neuropsychiatric Inventory - 12 Item Version Questionnaire 4 | 2022-03-25 Update C100772 CDISC Synonym QSCAT Category of Questionnaire Add new CDISC Synonym - - - NPI-12 5 | 2022-03-25 Add C185761 Term QSCAT Category of Questionnaire Add new term to existing codelist - - - SF6D V2.0 ACUTE 6 | 2022-03-25 Add C185762 Term QSCAT Category of Questionnaire Add new term to existing codelist - - - SF6D V2.0 STANDARD 7 | 2022-03-25 Add C185787 Term SF363TC The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36334 8 | 2022-03-25 Add C185788 Term SF363TC The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36335 9 | 2022-03-25 Add C185789 Term SF363TC The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36336 10 | 2022-03-25 Add C185790 Term SF363TC The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36337 11 | 2022-03-25 Add C185787 Term SF363TN The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF363-Utility Index Score UK Weights 12 | 2022-03-25 Add C185788 Term SF363TN The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF363-Utility Index Score CN Weights 13 | 2022-03-25 Add C185789 Term SF363TN The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF363-Utility Index Score AU Weights 14 | 2022-03-25 Add C185790 Term SF363TN The Short Form 36 Health Survey Standard, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF363-Utility Index Score US Weights 15 | 2022-03-25 Add C185783 Term SF364TC The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36434 16 | 2022-03-25 Add C185784 Term SF364TC The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36435 17 | 2022-03-25 Add C185785 Term SF364TC The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36436 18 | 2022-03-25 Add C185786 Term SF364TC The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Code Add new term to existing codelist - - - SF36437 19 | 2022-03-25 Add C185783 Term SF364TN The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF364-Utility Index Score UK Weights 20 | 2022-03-25 Add C185784 Term SF364TN The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF364-Utility Index Score CN Weights 21 | 2022-03-25 Add C185785 Term SF364TN The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF364-Utility Index Score AU Weights 22 | 2022-03-25 Add C185786 Term SF364TN The Short Form 36 Health Survey Acute, US Version 2.0 Questionnaire Test Name Add new term to existing codelist - - - SF364-Utility Index Score US Weights 23 | 2022-03-25 Add C185742 CDISC Codelist SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Addition of new codelist - - - SF6D1TC 24 | 2022-03-25 Add C185773 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D101 25 | 2022-03-25 Add C185774 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D102 26 | 2022-03-25 Add C185775 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D103 27 | 2022-03-25 Add C185776 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D104 28 | 2022-03-25 Add C185777 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D105 29 | 2022-03-25 Add C185778 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D106 30 | 2022-03-25 Add C185779 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D107 31 | 2022-03-25 Add C185780 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D108 32 | 2022-03-25 Add C185781 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D109 33 | 2022-03-25 Add C185782 Term SF6D1TC SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D110 34 | 2022-03-25 Add C185741 CDISC Codelist SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Addition of new codelist - - - SF6D1TN 35 | 2022-03-25 Add C185773 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Health Limit Physical Activities 36 | 2022-03-25 Add C185774 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Accomplished Less Due to Problems 37 | 2022-03-25 Add C185775 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-How Much Bodily Pain Have You Had 38 | 2022-03-25 Add C185776 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Time Have You Felt Worn Out 39 | 2022-03-25 Add C185777 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Interfered With Social Activities 40 | 2022-03-25 Add C185778 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Time Felt Depressed/Very Nervous 41 | 2022-03-25 Add C185779 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Utility Index Score UK Weights 42 | 2022-03-25 Add C185780 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Utility Index Score CN Weights 43 | 2022-03-25 Add C185781 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Utility Index Score AU Weights 44 | 2022-03-25 Add C185782 Term SF6D1TN SF-6Dv2 Health Utility Survey Standard, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D1-Utility Index Score US Weights 45 | 2022-03-25 Add C185740 CDISC Codelist SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Addition of new codelist - - - SF6D2TC 46 | 2022-03-25 Add C185763 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D201 47 | 2022-03-25 Add C185764 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D202 48 | 2022-03-25 Add C185765 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D203 49 | 2022-03-25 Add C185766 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D204 50 | 2022-03-25 Add C185767 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D205 51 | 2022-03-25 Add C185768 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D206 52 | 2022-03-25 Add C185769 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D207 53 | 2022-03-25 Add C185770 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D208 54 | 2022-03-25 Add C185771 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D209 55 | 2022-03-25 Add C185772 Term SF6D2TC SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Code Add new term to new codelist - - - SF6D210 56 | 2022-03-25 Add C185739 CDISC Codelist SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Addition of new codelist - - - SF6D2TN 57 | 2022-03-25 Add C185763 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Health Limit Physical Activities 58 | 2022-03-25 Add C185764 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Accomplished Less Due to Problems 59 | 2022-03-25 Add C185765 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-How Much Bodily Pain Have You Had 60 | 2022-03-25 Add C185766 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Time Have You Felt Worn Out 61 | 2022-03-25 Add C185767 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Interfered With Social Activities 62 | 2022-03-25 Add C185768 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Time Felt Depressed/Very Nervous 63 | 2022-03-25 Add C185769 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Utililty Index Score UK Weights 64 | 2022-03-25 Add C185770 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Utility Index Score CN Weights 65 | 2022-03-25 Add C185771 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Utility Index Score AU Weights 66 | 2022-03-25 Add C185772 Term SF6D2TN SF-6Dv2 Health Utility Survey Acute, English Version 2.0 Questionnaire Test Name Add new term to new codelist - - - SF6D2-Utility Index Score US Weights 67 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/expected/SEND Terminology Changes.txt: -------------------------------------------------------------------------------- 1 | Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2 | 2022-03-25 Add C65979 Term CHAGNAMR Chemical Challenge Agent Name Response Add new term to existing codelist - - - DIISOPROPYL FLUOROPHOSPHATE 3 | 2022-03-25 Add C152434 Term CHAGNAMR Chemical Challenge Agent Name Response Add new term to existing codelist - - - TETRACHLORVINPHOS 4 | 2022-03-25 Remove C163646 Term CHAGNAMR Chemical Challenge Agent Name Response Remove term entirely from codelist DIAZINON - - - 5 | 2022-03-25 Remove C163648 Term CHAGNAMR Chemical Challenge Agent Name Response Remove term entirely from codelist DIISOPROPYL FLUOROPHOSPHATE - - - 6 | 2022-03-25 Remove C163708 Term CHAGNAMR Chemical Challenge Agent Name Response Remove term entirely from codelist TETRACHLORVINPHOS - - - 7 | 2022-03-25 Add C169912 Term CHAGNAMR Chemical Challenge Agent Name Response Add new term to existing codelist - - - DIAZINON 8 | 2022-03-25 Add C186020 Term DIR Directionality Add new term to existing codelist - - - CRANIOCAUDAL 9 | 2022-03-25 Add C186021 Term DIR Directionality Add new term to existing codelist - - - SEPTAL 10 | 2022-03-25 Add C3824 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - LESION 11 | 2022-03-25 Add C25626 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - PRESENT 12 | 2022-03-25 Add C43429 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - DEFECT 13 | 2022-03-25 Add C43623 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - PERSISTENT 14 | 2022-03-25 Remove C62265 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist DOUBLED - - - 15 | 2022-03-25 Remove C84473 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist ATRIAL SEPTAL DEFECT - - - 16 | 2022-03-25 Remove C98912 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist DIAPHRAGMATIC EVENTRATION - - - 17 | 2022-03-25 Remove C101029 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist ATRIOVENTRICULAR SEPTAL DEFECT - - - 18 | 2022-03-25 Update C124489 CDISC Synonym FXFINDRS Fetal Pathology Findings Result Add new CDISC Synonym - - - Malpositioned Origin 19 | 2022-03-25 Update C124491 CDISC Synonym FXFINDRS Fetal Pathology Findings Result Add new CDISC Synonym - - - Altered Surface Texture 20 | 2022-03-25 Remove C124495 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist AORTICOPULMONARY SEPTAL DEFECT - - - 21 | 2022-03-25 Remove C124556 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist MEMBRANOUS VENTRICULAR SEPTAL DEFECT - - - 22 | 2022-03-25 Remove C124563 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist MUSCULAR VENTRICULAR SEPTAL DEFECT - - - 23 | 2022-03-25 Remove C124570 Term FXFINDRS Fetal Pathology Findings Result Remove term entirely from codelist PERSISTENT - - - 24 | 2022-03-25 Add C185902 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - EVENTRATION 25 | 2022-03-25 Add C185903 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - DUPLICATED 26 | 2022-03-25 Add C186225 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - ABNORMAL FLUID OR SUBSTANCE 27 | 2022-03-25 Add C186226 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - ADHERED TO CORNEA 28 | 2022-03-25 Add C186227 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - ASYMMETRIC 29 | 2022-03-25 Add C186228 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - BRANCHING VARIATION 30 | 2022-03-25 Add C186229 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - COMMON CAROTID TRUNK 31 | 2022-03-25 Add C186230 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - DISTAL OSSIFICATION SITE 32 | 2022-03-25 Add C186231 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - EXTRACAPSULAR TISSUE 33 | 2022-03-25 Add C186232 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - MISSHAPEN OSSIFICATION SITE 34 | 2022-03-25 Add C186233 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - PARTIALLY DUPLICATED 35 | 2022-03-25 Add C186234 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - PERSISTENT ATRIOVENTRICULAR CANAL 36 | 2022-03-25 Add C186235 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - PROXIMAL OSSIFICATION SITE 37 | 2022-03-25 Add C186236 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - RETROCAVAL 38 | 2022-03-25 Add C186237 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SINGLE INCISOR SOCKET 39 | 2022-03-25 Add C186238 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUBCUTANEOUS EDEMA 40 | 2022-03-25 Add C186239 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUPERNUMERARY BRANCH 41 | 2022-03-25 Add C186240 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUPERNUMERARY HEMIVERTEBRA 42 | 2022-03-25 Add C186241 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUPERNUMERARY LOBE 43 | 2022-03-25 Add C186242 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUPERNUMERARY OSSIFICATION SITE 44 | 2022-03-25 Add C186243 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUPERNUMERARY RIB, ARTICULATED 45 | 2022-03-25 Add C186244 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUPERNUMERARY RIB, NON-ARTICULATED 46 | 2022-03-25 Add C186245 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - SUTURAL BONE 47 | 2022-03-25 Add C186246 Term FXFINDRS Fetal Pathology Findings Result Add new term to existing codelist - - - UNILATERAL OSSIFICATION 48 | 2022-03-25 Update C74853 CDISC Synonym LBTEST Laboratory Test Name Add new CDISC Synonym - - - Androstanolone 49 | 2022-03-25 Add C81251 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Galactose-1-Phos Uridylyltransferase 50 | 2022-03-25 Add C81281 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Phenylalanine/Tyrosine 51 | 2022-03-25 Add C81308 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Galactose 52 | 2022-03-25 Update C127628 CDISC Synonym LBTEST Laboratory Test Name Add new CDISC Synonym - - - Erythroid Precursors/Total Cells 53 | 2022-03-25 Add C141271 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Neutrophils/Lymphocytes 54 | 2022-03-25 Update C156509 CDISC Synonym LBTEST Laboratory Test Name Add new CDISC Synonym - - - NUMA1 55 | 2022-03-25 Update C156509 CDISC Synonym LBTEST Laboratory Test Name Add new CDISC Synonym - - - Nuclear Mitotic Apparatus Protein 1 56 | 2022-03-25 Add C186022 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Alpha-1 Microglobulin Excretion Rate 57 | 2022-03-25 Add C186023 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Amitriptyline 58 | 2022-03-25 Add C186024 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Ammonium 59 | 2022-03-25 Add C186025 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Ammonium/Creatinine 60 | 2022-03-25 Add C186026 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Androsterone 61 | 2022-03-25 Add C186027 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 3-Alpha-Androstanediol Glucuronide 62 | 2022-03-25 Add C186028 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Beta-Hydroxybutyrate/Acetoacetate 63 | 2022-03-25 Add C186029 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Complement C1q 64 | 2022-03-25 Add C186030 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Cyclic Adenosine Monophosphate/Creat 65 | 2022-03-25 Add C186031 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Clonazepam and/or Metabolites 66 | 2022-03-25 Add C186032 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Alpha Cortol 67 | 2022-03-25 Add C186033 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Alpha Cortolone 68 | 2022-03-25 Add C186034 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Carotene 69 | 2022-03-25 Add C186035 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Pathologic Casts 70 | 2022-03-25 Add C186036 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Circulating Tumor Cells, Apoptotic 71 | 2022-03-25 Add C186037 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Catecholamines 72 | 2022-03-25 Add C186038 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Circulating Tumor Cells, Traditional 73 | 2022-03-25 Add C186039 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Chemokine (C-X-C Motif) Ligand 2 74 | 2022-03-25 Add C186040 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Desipramine 75 | 2022-03-25 Add C186041 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Doxepin and/or Metabolites 76 | 2022-03-25 Add C186042 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Deoxycorticosteroids 77 | 2022-03-25 Add C186043 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Deoxycortisol 78 | 2022-03-25 Add C186044 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 21-Deoxycortisol 79 | 2022-03-25 Add C186045 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Deoxycorticosterone 80 | 2022-03-25 Add C186046 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 21-Deoxycorticosterone 81 | 2022-03-25 Add C186047 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Erythroferrone 82 | 2022-03-25 Add C186048 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Flunitrazepam and/or Metabolites 83 | 2022-03-25 Add C186049 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Glycated Ferritin 84 | 2022-03-25 Add C186050 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Glycated Ferritin/Ferritin 85 | 2022-03-25 Add C186051 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Flurazepam and/or Metabolites 86 | 2022-03-25 Add C186052 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Galactose-1-Phosphate 87 | 2022-03-25 Add C186053 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Galectin-3 Binding Protein 88 | 2022-03-25 Add C186054 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Glucose, Radiolabeled/Glucose 89 | 2022-03-25 Add C186055 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Granulocytes Band Form 90 | 2022-03-25 Add C186056 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Granulocytes Segmented 91 | 2022-03-25 Add C186057 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Growth Regulated Oncogene 92 | 2022-03-25 Add C186058 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 6a OH-tetrahydro-11-DeH-Corticosterone 93 | 2022-03-25 Add C186059 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 6a OH-tetrahydro-11-Deoxycortisol 94 | 2022-03-25 Add C186060 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Hydrogen+Methane 95 | 2022-03-25 Add C186061 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - HLA DQ2 Antigen 96 | 2022-03-25 Add C186062 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - HLA DQ8 Antigen 97 | 2022-03-25 Add C186063 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Hydroxyandrostenedione 98 | 2022-03-25 Add C186064 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Hydroxyandrosterone 99 | 2022-03-25 Add C186065 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 17-Hydroxycorticosteroids 100 | 2022-03-25 Add C186066 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 18-Hydroxycortisol 101 | 2022-03-25 Add C186067 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 18-Hydroxycorticosterone 102 | 2022-03-25 Add C186068 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 18-Hydroxydeoxycorticosterone 103 | 2022-03-25 Add C186069 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Hydroxyetiocholanolone 104 | 2022-03-25 Add C186070 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 17-Hydroxypregnenolone 105 | 2022-03-25 Add C186071 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Imipramine 106 | 2022-03-25 Add C186072 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Insulin, Intact 107 | 2022-03-25 Add C186073 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Ketoandrosterone 108 | 2022-03-25 Add C186074 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 11-Ketoetiocholanolone 109 | 2022-03-25 Add C186075 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 17-Ketogenic steroids 110 | 2022-03-25 Add C186076 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 17-Ketosteroids 111 | 2022-03-25 Add C186077 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Lactose 112 | 2022-03-25 Add C186078 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Lymphoma Cells/Total Cells 113 | 2022-03-25 Add C186079 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Lymphocytes/Neutrophils 114 | 2022-03-25 Add C186080 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Methane 115 | 2022-03-25 Add C186081 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Monoclonal Prot Immunoglobulin Isotype 116 | 2022-03-25 Add C186082 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 3-Methoxytyramine 117 | 2022-03-25 Add C186083 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 3-Methoxytyramine, Free 118 | 2022-03-25 Add C186084 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Myeloid Progenitor Cells/Total Cells 119 | 2022-03-25 Add C186085 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Non-HDL Cholesterol/LDL Cholesterol 120 | 2022-03-25 Add C186086 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Normetanephrine, Free 121 | 2022-03-25 Add C186087 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Nortriptyline 122 | 2022-03-25 Add C186088 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Norpropoxyphene 123 | 2022-03-25 Add C186089 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Nitrazepam and/or Metabolites 124 | 2022-03-25 Add C186090 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Para-Aminobenzoate 125 | 2022-03-25 Add C186091 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Prprot Cnvrtase Subtilisin-Kexin 9, Free 126 | 2022-03-25 Add C186092 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Pregnanediol 127 | 2022-03-25 Add C186093 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Serum-Ascites Albumin Gradient 128 | 2022-03-25 Add C186094 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Schistocytes/Erythrocytes 129 | 2022-03-25 Add C186095 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Succinylacetone 130 | 2022-03-25 Add C186096 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Soluble Intercell Adhesion Molecule 4 131 | 2022-03-25 Add C186097 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - 5-Alpha Tetrahydrocortisol 132 | 2022-03-25 Add C186098 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Xylose/Xylose Dose 133 | 2022-03-25 Add C186099 Term LBTEST Laboratory Test Name Add new term to existing codelist - - - Xylose 134 | 2022-03-25 Update C74853 CDISC Synonym LBTESTCD Laboratory Test Code Add new CDISC Synonym - - - Androstanolone 135 | 2022-03-25 Add C81251 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GAL1PUT 136 | 2022-03-25 Add C81281 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - PHETYR 137 | 2022-03-25 Add C81308 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GAL 138 | 2022-03-25 Update C127628 CDISC Synonym LBTESTCD Laboratory Test Code Add new CDISC Synonym - - - Erythroid Precursors/Total Cells 139 | 2022-03-25 Add C141271 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - NEUTLY 140 | 2022-03-25 Update C156509 CDISC Synonym LBTESTCD Laboratory Test Code Add new CDISC Synonym - - - NUMA1 141 | 2022-03-25 Update C156509 CDISC Synonym LBTESTCD Laboratory Test Code Add new CDISC Synonym - - - Nuclear Mitotic Apparatus Protein 1 142 | 2022-03-25 Add C186022 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - A1MCGEXR 143 | 2022-03-25 Add C186023 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - AMITRPTL 144 | 2022-03-25 Add C186024 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - AMNM 145 | 2022-03-25 Add C186025 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - AMNMCRT 146 | 2022-03-25 Add C186026 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - ANDSTRN 147 | 2022-03-25 Add C186027 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - ASTDLG3A 148 | 2022-03-25 Add C186028 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - BHBACTAC 149 | 2022-03-25 Add C186029 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - C1Q 150 | 2022-03-25 Add C186030 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CAMPCRT 151 | 2022-03-25 Add C186031 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CLZPMAOM 152 | 2022-03-25 Add C186032 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CORTOLA 153 | 2022-03-25 Add C186033 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CORTOLNA 154 | 2022-03-25 Add C186034 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CRTN 155 | 2022-03-25 Add C186035 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CSPATH 156 | 2022-03-25 Add C186036 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CTCAPOP 157 | 2022-03-25 Add C186037 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CTCHLMN 158 | 2022-03-25 Add C186038 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CTCTRAD 159 | 2022-03-25 Add C186039 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - CXCL2 160 | 2022-03-25 Add C186040 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DESIPRMN 161 | 2022-03-25 Add C186041 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DOXPNAOM 162 | 2022-03-25 Add C186042 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DXCSD11 163 | 2022-03-25 Add C186043 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DXCSL11 164 | 2022-03-25 Add C186044 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DXCSL21 165 | 2022-03-25 Add C186045 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DXCSN11 166 | 2022-03-25 Add C186046 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - DXCSN21 167 | 2022-03-25 Add C186047 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - ERFE 168 | 2022-03-25 Add C186048 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - FNZPMAOM 169 | 2022-03-25 Add C186049 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - FRNG 170 | 2022-03-25 Add C186050 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - FRNGFRN 171 | 2022-03-25 Add C186051 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - FRZPMAOM 172 | 2022-03-25 Add C186052 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GAL1PHOS 173 | 2022-03-25 Add C186053 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GLCTN3BP 174 | 2022-03-25 Add C186054 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GLURLGLU 175 | 2022-03-25 Add C186055 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GRANB 176 | 2022-03-25 Add C186056 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GRANSG 177 | 2022-03-25 Add C186057 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - GRO 178 | 2022-03-25 Add C186058 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - H411DC6A 179 | 2022-03-25 Add C186059 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - H411DS6A 180 | 2022-03-25 Add C186060 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HCH4 181 | 2022-03-25 Add C186061 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HLADQ2 182 | 2022-03-25 Add C186062 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HLADQ8 183 | 2022-03-25 Add C186063 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXANSD11 184 | 2022-03-25 Add C186064 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXANST11 185 | 2022-03-25 Add C186065 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXCSD17 186 | 2022-03-25 Add C186066 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXCSL18 187 | 2022-03-25 Add C186067 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXCSN18 188 | 2022-03-25 Add C186068 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXDX 18 189 | 2022-03-25 Add C186069 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXETCL11 190 | 2022-03-25 Add C186070 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - HXPRGN17 191 | 2022-03-25 Add C186071 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - IMIPRMN 192 | 2022-03-25 Add C186072 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - INSULINI 193 | 2022-03-25 Add C186073 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - KTANST11 194 | 2022-03-25 Add C186074 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - KTETCL11 195 | 2022-03-25 Add C186075 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - KTGSTR17 196 | 2022-03-25 Add C186076 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - KTSTR17 197 | 2022-03-25 Add C186077 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - LACTOSE 198 | 2022-03-25 Add C186078 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - LYMMCECE 199 | 2022-03-25 Add C186079 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - LYMNE 200 | 2022-03-25 Add C186080 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - METHANE 201 | 2022-03-25 Add C186081 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - MPIGISO 202 | 2022-03-25 Add C186082 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - MTHXT3 203 | 2022-03-25 Add C186083 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - MTHXT3FR 204 | 2022-03-25 Add C186084 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - MYPCCE 205 | 2022-03-25 Add C186085 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - NHDLLDL 206 | 2022-03-25 Add C186086 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - NORMETFR 207 | 2022-03-25 Add C186087 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - NORTRPTL 208 | 2022-03-25 Add C186088 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - NRPROPOX 209 | 2022-03-25 Add C186089 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - NTZPMAOM 210 | 2022-03-25 Add C186090 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - PABA 211 | 2022-03-25 Add C186091 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - PCSK9FR 212 | 2022-03-25 Add C186092 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - PRGNNDL 213 | 2022-03-25 Add C186093 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - SAAG 214 | 2022-03-25 Add C186094 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - SCHISRBC 215 | 2022-03-25 Add C186095 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - SCNYLACT 216 | 2022-03-25 Add C186096 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - SICAM4 217 | 2022-03-25 Add C186097 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - THDCSL5A 218 | 2022-03-25 Add C186098 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - XLSXLSD 219 | 2022-03-25 Add C186099 Term LBTESTCD Laboratory Test Code Add new term to existing codelist - - - XYLOSE 220 | 2022-03-25 Add C12228 Term LOC Anatomical Location Add new term to existing codelist - - - BASE OF THE TONGUE 221 | 2022-03-25 Add C12232 Term LOC Anatomical Location Add new term to existing codelist - - - PALATINE UVULA 222 | 2022-03-25 Update C12292 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Pinna 223 | 2022-03-25 Add C12318 Term LOC Anatomical Location Add new term to existing codelist - - - BROAD LIGAMENT 224 | 2022-03-25 Add C12373 Term LOC Anatomical Location Add new term to existing codelist - - - CARTILAGE 225 | 2022-03-25 Add C12473 Term LOC Anatomical Location Add new term to existing codelist - - - SYNOVIUM 226 | 2022-03-25 Add C12494 Term LOC Anatomical Location Add new term to existing codelist - - - CLIVUS 227 | 2022-03-25 Add C12684 Term LOC Anatomical Location Add new term to existing codelist - - - BRONCHIOLE 228 | 2022-03-25 Add C12698 Term LOC Anatomical Location Add new term to existing codelist - - - COMMON BILE DUCT 229 | 2022-03-25 Update C12751 CDISC Definition LOC Anatomical Location Update CDISC Definition Any of the five bones between the wrist and the fingers that form the skeleton of the palm. (NCI) Any of the bones between the carpus and the phalanges. 230 | 2022-03-25 Update C12752 CDISC Definition LOC Anatomical Location Update CDISC Definition A bone belonging to the middle part of the foot located between toes and ankle. There are 5 metatarsal bones and they are numbered from the medial side. (NCI) Any of the bones between the tarsus and the phalanges. 231 | 2022-03-25 Add C12757 Term LOC Anatomical Location Add new term to existing codelist - - - OCCIPITAL BONE 232 | 2022-03-25 Add C12766 Term LOC Anatomical Location Add new term to existing codelist - - - PARIETAL BONE 233 | 2022-03-25 Add C12790 Term LOC Anatomical Location Add new term to existing codelist - - - SPHENOID BONE 234 | 2022-03-25 Update C12815 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Caudal Vena Cava 235 | 2022-03-25 Update C12815 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Posterior Vena Cava 236 | 2022-03-25 Update C12816 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Anterior Vena Cava 237 | 2022-03-25 Update C12816 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Cranial Vena Cava 238 | 2022-03-25 Add C13011 Term LOC Anatomical Location Add new term to existing codelist - - - AMPULLA OF VATER 239 | 2022-03-25 Add C13039 Term LOC Anatomical Location Add new term to existing codelist - - - UTERINE WALL 240 | 2022-03-25 Add C13045 Term LOC Anatomical Location Add new term to existing codelist - - - TENDON 241 | 2022-03-25 Add C13074 Term LOC Anatomical Location Add new term to existing codelist - - - MASSETER MUSCLE 242 | 2022-03-25 Add C13188 Term LOC Anatomical Location Add new term to existing codelist - - - AMNIOTIC FLUID 243 | 2022-03-25 Add C13190 Term LOC Anatomical Location Add new term to existing codelist - - - AQUEOUS HUMOR 244 | 2022-03-25 Add C25264 Term LOC Anatomical Location Add new term to existing codelist - - - CARINA 245 | 2022-03-25 Add C32069 Term LOC Anatomical Location Add new term to existing codelist - - - ANAL REGION 246 | 2022-03-25 Add C32097 Term LOC Anatomical Location Add new term to existing codelist - - - ANTERIOR MEDIASTINAL LYMPH NODE 247 | 2022-03-25 Add C32164 Term LOC Anatomical Location Add new term to existing codelist - - - AUDITORY OSSICLE 248 | 2022-03-25 Add C32307 Term LOC Anatomical Location Add new term to existing codelist - - - CHORDAE TENDINEAE 249 | 2022-03-25 Add C32455 Term LOC Anatomical Location Add new term to existing codelist - - - DESCENDING AORTA 250 | 2022-03-25 Add C32538 Term LOC Anatomical Location Add new term to existing codelist - - - ESOPHAGEAL MUCOSA 251 | 2022-03-25 Add C32575 Term LOC Anatomical Location Add new term to existing codelist - - - EYEBROW 252 | 2022-03-25 Add C32621 Term LOC Anatomical Location Add new term to existing codelist - - - FONTANELLE 253 | 2022-03-25 Add C32635 Term LOC Anatomical Location Add new term to existing codelist - - - FRONTAL BONE 254 | 2022-03-25 Add C32656 Term LOC Anatomical Location Add new term to existing codelist - - - GASTRIC MUCOSA 255 | 2022-03-25 Add C32719 Term LOC Anatomical Location Add new term to existing codelist - - - HEAD OF THE FIBULA 256 | 2022-03-25 Add C32797 Term LOC Anatomical Location Add new term to existing codelist - - - INFRASPINATUS MUSCLE 257 | 2022-03-25 Update C32818 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Atrial Septum 258 | 2022-03-25 Update C32874 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Ventricular Septum 259 | 2022-03-25 Add C33049 Term LOC Anatomical Location Add new term to existing codelist - - - FORESKIN 260 | 2022-03-25 Add C33105 Term LOC Anatomical Location Add new term to existing codelist - - - MESOTHELIUM 261 | 2022-03-25 Update C33157 CDISC Definition LOC Anatomical Location Update CDISC Definition One of two small oblong bones placed side by side at the middle and upper part of the face. (NCI) A bone of the skull forming the middle and upper part of the face. 262 | 2022-03-25 Add C33259 Term LOC Anatomical Location Add new term to existing codelist - - - PAPILLARY MUSCLE 263 | 2022-03-25 Add C33460 Term LOC Anatomical Location Add new term to existing codelist - - - RENAL PAPILLA 264 | 2022-03-25 Add C33462 Term LOC Anatomical Location Add new term to existing codelist - - - RENAL VEIN 265 | 2022-03-25 Add C33540 Term LOC Anatomical Location Add new term to existing codelist - - - SERRATUS ANTERIOR MUSCLE 266 | 2022-03-25 Add C33568 Term LOC Anatomical Location Add new term to existing codelist - - - SMALL INTESTINAL MUCOSA 267 | 2022-03-25 Add C33827 Term LOC Anatomical Location Add new term to existing codelist - - - UMBILICAL ARTERY 268 | 2022-03-25 Add C33830 Term LOC Anatomical Location Add new term to existing codelist - - - UMBILICAL VEIN 269 | 2022-03-25 Add C34241 Term LOC Anatomical Location Add new term to existing codelist - - - HEART, FORAMEN OVALE 270 | 2022-03-25 Add C48824 Term LOC Anatomical Location Add new term to existing codelist - - - LUMBOSACRAL SPINE 271 | 2022-03-25 Add C49478 Term LOC Anatomical Location Add new term to existing codelist - - - INTESTINAL WALL 272 | 2022-03-25 Update C52888 CDISC Submission Value LOC Anatomical Location Update CDISC Submission Value ADDUCTOR POLLICIS MUSCLE ABDUCTOR POLLICIS LONGUS MUSCLE 273 | 2022-03-25 Add C52914 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR CARPI ULNARIS MUSCLE 274 | 2022-03-25 Add C52916 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR DIGITORUM MUSCLE 275 | 2022-03-25 Add C52918 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR DIGITORUM LONGUS MUSCLE 276 | 2022-03-25 Add C52928 Term LOC Anatomical Location Add new term to existing codelist - - - GENIOGLOSSUS MUSCLE 277 | 2022-03-25 Add C52933 Term LOC Anatomical Location Add new term to existing codelist - - - GLUTEUS MEDIUS 278 | 2022-03-25 Add C53072 Term LOC Anatomical Location Add new term to existing codelist - - - TENSOR FASCIA LATA MUSCLE 279 | 2022-03-25 Add C53171 Term LOC Anatomical Location Add new term to existing codelist - - - PERONEUS LONGUS MUSCLE 280 | 2022-03-25 Add C54155 Term LOC Anatomical Location Add new term to existing codelist - - - RETRO-ORBITAL REGION 281 | 2022-03-25 Add C66852 Term LOC Anatomical Location Add new term to existing codelist - - - CAROTID BODY 282 | 2022-03-25 Add C77644 Term LOC Anatomical Location Add new term to existing codelist - - - PERITONEAL LYMPH NODE 283 | 2022-03-25 Add C77675 Term LOC Anatomical Location Add new term to existing codelist - - - SURAL NERVE 284 | 2022-03-25 Add C89749 Term LOC Anatomical Location Add new term to existing codelist - - - ALVEOLAR PROCESS 285 | 2022-03-25 Add C89780 Term LOC Anatomical Location Add new term to existing codelist - - - SCALENE LYMPH NODE 286 | 2022-03-25 Update C93179 CDISC Submission Value LOC Anatomical Location Update CDISC Submission Value KIDNEY, UPPER LOBE KIDNEY, UPPER POLE 287 | 2022-03-25 Update C93179 CDISC Definition LOC Anatomical Location Update CDISC Definition The lobe of the kidney located in the uppermost region of the kidney. (NCI) The uppermost portion of the kidney. 288 | 2022-03-25 Update C93179 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Upper Pole of the Kidney 289 | 2022-03-25 Update C93179 CDISC Synonym LOC Anatomical Location Remove CDISC Synonym Upper Lobe of the Kidney - - - 290 | 2022-03-25 Update C93180 CDISC Submission Value LOC Anatomical Location Update CDISC Submission Value KIDNEY, LOWER LOBE KIDNEY, LOWER POLE 291 | 2022-03-25 Update C93180 CDISC Definition LOC Anatomical Location Update CDISC Definition The lobe of the kidney located in the lowest portion of the kidney. (NCI) The lowermost portion of the kidney. 292 | 2022-03-25 Update C93180 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Lower Pole of the Kidney 293 | 2022-03-25 Update C93180 CDISC Synonym LOC Anatomical Location Remove CDISC Synonym Lower Lobe of the Kidney - - - 294 | 2022-03-25 Add C97112 Term LOC Anatomical Location Add new term to existing codelist - - - AORTIC BODY 295 | 2022-03-25 Update C97925 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Paraspinal Ganglion 296 | 2022-03-25 Update C97925 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Spinal Ganglion 297 | 2022-03-25 Update C103238 CDISC Synonym LOC Anatomical Location Add new CDISC Synonym - - - Antecubital Region 298 | 2022-03-25 Add C128630 Term LOC Anatomical Location Add new term to existing codelist - - - GLOTTIS, ANTERIOR COMMISSURE 299 | 2022-03-25 Add C129430 Term LOC Anatomical Location Add new term to existing codelist - - - ALISPHENOID PROCESS 300 | 2022-03-25 Add C161570 Term LOC Anatomical Location Add new term to existing codelist - - - UTERINE HORN 301 | 2022-03-25 Add C164003 Term LOC Anatomical Location Add new term to existing codelist - - - COLONIC MUCOSA 302 | 2022-03-25 Add C164004 Term LOC Anatomical Location Add new term to existing codelist - - - MEDIASTINAL SOFT TISSUE 303 | 2022-03-25 Add C164006 Term LOC Anatomical Location Add new term to existing codelist - - - NASAL SOFT TISSUE 304 | 2022-03-25 Add C164007 Term LOC Anatomical Location Add new term to existing codelist - - - PERI-ORBITAL SOFT TISSUE 305 | 2022-03-25 Add C164282 Term LOC Anatomical Location Add new term to existing codelist - - - GLOTTIS, POSTERIOR COMMISSURE 306 | 2022-03-25 Add C165177 Term LOC Anatomical Location Add new term to existing codelist - - - ANAL SPHINCTER 307 | 2022-03-25 Add C165584 Term LOC Anatomical Location Add new term to existing codelist - - - EXTRAABDOMINAL LYMPH NODE 308 | 2022-03-25 Add C186100 Term LOC Anatomical Location Add new term to existing codelist - - - ADDUCTOR POLLICIS MUSCLE 309 | 2022-03-25 Add C186101 Term LOC Anatomical Location Add new term to existing codelist - - - ANCONEUS MUSCLE 310 | 2022-03-25 Add C186102 Term LOC Anatomical Location Add new term to existing codelist - - - ANORECTUM 311 | 2022-03-25 Add C186103 Term LOC Anatomical Location Add new term to existing codelist - - - AORTICOPULMONARY SEPTUM 312 | 2022-03-25 Add C186104 Term LOC Anatomical Location Add new term to existing codelist - - - ATRIOVENTRICULAR SEPTUM 313 | 2022-03-25 Add C186105 Term LOC Anatomical Location Add new term to existing codelist - - - BASIOCCIPITAL BONE 314 | 2022-03-25 Add C186106 Term LOC Anatomical Location Add new term to existing codelist - - - BASISPHENOID BONE 315 | 2022-03-25 Add C186107 Term LOC Anatomical Location Add new term to existing codelist - - - BRONCHIAL STUMP 316 | 2022-03-25 Add C186108 Term LOC Anatomical Location Add new term to existing codelist - - - CEREBELLAR LOBE 317 | 2022-03-25 Add C186109 Term LOC Anatomical Location Add new term to existing codelist - - - DERMAL PAPILLAE OF THE FACE 318 | 2022-03-25 Add C186110 Term LOC Anatomical Location Add new term to existing codelist - - - EXOCCIPITAL BONE 319 | 2022-03-25 Add C186111 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR DIGITI MINIMI MUSCLE 320 | 2022-03-25 Add C186112 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR HALLUCIS LONGUS MUSCLE 321 | 2022-03-25 Add C186113 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR INDICIS PROPRIUS MUSCLE 322 | 2022-03-25 Add C186114 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR POLLICIS BREVIS MUSCLE 323 | 2022-03-25 Add C186115 Term LOC Anatomical Location Add new term to existing codelist - - - EXTENSOR POLLICIS LONGUS MUSCLE 324 | 2022-03-25 Add C186116 Term LOC Anatomical Location Add new term to existing codelist - - - FLEXOR POLLICIS BREVIS MUSCLE 325 | 2022-03-25 Add C186117 Term LOC Anatomical Location Add new term to existing codelist - - - FOREARM PRONATOR MUSCLES 326 | 2022-03-25 Add C186118 Term LOC Anatomical Location Add new term to existing codelist - - - FOREPAW PHALANX 327 | 2022-03-25 Add C186119 Term LOC Anatomical Location Add new term to existing codelist - - - FRONTALIS MUSCLE 328 | 2022-03-25 Add C186120 Term LOC Anatomical Location Add new term to existing codelist - - - HEART, VENTRICULAR CHAMBER 329 | 2022-03-25 Add C186121 Term LOC Anatomical Location Add new term to existing codelist - - - HINDPAW PHALANX 330 | 2022-03-25 Add C186122 Term LOC Anatomical Location Add new term to existing codelist - - - HIP FLEXOR MUSCLES 331 | 2022-03-25 Add C186123 Term LOC Anatomical Location Add new term to existing codelist - - - INTERPARIETAL BONE 332 | 2022-03-25 Add C186124 Term LOC Anatomical Location Add new term to existing codelist - - - KIDNEY INTERPOLAR REGION 333 | 2022-03-25 Add C186125 Term LOC Anatomical Location Add new term to existing codelist - - - KNEE FLEXOR MUSCLES 334 | 2022-03-25 Add C186126 Term LOC Anatomical Location Add new term to existing codelist - - - LUMBRICAL MUSCLES OF THE FOOT 335 | 2022-03-25 Add C186127 Term LOC Anatomical Location Add new term to existing codelist - - - MENTALIS MUSCLE 336 | 2022-03-25 Add C186128 Term LOC Anatomical Location Add new term to existing codelist - - - OROPHARYNGEAL SOFT TISSUE 337 | 2022-03-25 Add C186129 Term LOC Anatomical Location Add new term to existing codelist - - - PALATAL RUGAE 338 | 2022-03-25 Add C186130 Term LOC Anatomical Location Add new term to existing codelist - - - PARATRACHEAL LYMPH NODE, UPPER 339 | 2022-03-25 Add C186131 Term LOC Anatomical Location Add new term to existing codelist - - - PERIMENINGEAL SPACE 340 | 2022-03-25 Add C186132 Term LOC Anatomical Location Add new term to existing codelist - - - PERONEUS BREVIS MUSCLE 341 | 2022-03-25 Add C186133 Term LOC Anatomical Location Add new term to existing codelist - - - PLANTAR FLEXOR MUSCLES 342 | 2022-03-25 Add C186134 Term LOC Anatomical Location Add new term to existing codelist - - - PREMAXILLA BONE 343 | 2022-03-25 Add C186135 Term LOC Anatomical Location Add new term to existing codelist - - - PRESPHENOID BONE 344 | 2022-03-25 Add C186136 Term LOC Anatomical Location Add new term to existing codelist - - - RHOMBOID MAJOR MUSCLE 345 | 2022-03-25 Add C186137 Term LOC Anatomical Location Add new term to existing codelist - - - RHOMBOID MINOR MUSCLE 346 | 2022-03-25 Add C186138 Term LOC Anatomical Location Add new term to existing codelist - - - SNOUT 347 | 2022-03-25 Add C186139 Term LOC Anatomical Location Add new term to existing codelist - - - SPINAL CORD PARENCHYMA 348 | 2022-03-25 Add C186140 Term LOC Anatomical Location Add new term to existing codelist - - - STOMACH WALL 349 | 2022-03-25 Add C186141 Term LOC Anatomical Location Add new term to existing codelist - - - SUPINATOR MUSCLE 350 | 2022-03-25 Add C186142 Term LOC Anatomical Location Add new term to existing codelist - - - SUPRAOCCIPITAL BONE 351 | 2022-03-25 Add C186143 Term LOC Anatomical Location Add new term to existing codelist - - - SUTURE 352 | 2022-03-25 Add C186144 Term LOC Anatomical Location Add new term to existing codelist - - - WHISKERS 353 | 2022-03-25 Add C25531 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - IMMATURE 354 | 2022-03-25 Add C48658 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - INDETERMINATE 355 | 2022-03-25 Add C185848 CDISC Codelist MIRCP Microscopy Reproductive Cycle Phase Response Addition of new codelist - - - MIRCP 356 | 2022-03-25 Add C186247 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - ANESTRUS 357 | 2022-03-25 Add C186248 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - DIESTRUS 358 | 2022-03-25 Add C186249 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - ESTRUS 359 | 2022-03-25 Add C186250 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - FOLLICULAR PHASE 360 | 2022-03-25 Add C186251 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - LUTEAL PHASE 361 | 2022-03-25 Add C186252 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - MENSTRUAL PHASE 362 | 2022-03-25 Add C186253 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - METESTRUS 363 | 2022-03-25 Add C186254 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - PROESTRUS 364 | 2022-03-25 Add C186255 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - REGENERATIVE PHASE 365 | 2022-03-25 Add C186256 Term MIRCP Microscopy Reproductive Cycle Phase Response Add new term to new codelist - - - SENESCENT 366 | 2022-03-25 Update C25531 CDISC Codelist Name MISXMAT Microscopy Sexual Maturity Status Response Update CDISC Codelist Name Microscopy Sexual Maturity Status Microscopy Sexual Maturity Status Response 367 | 2022-03-25 Update C48658 CDISC Codelist Name MISXMAT Microscopy Sexual Maturity Status Response Update CDISC Codelist Name Microscopy Sexual Maturity Status Microscopy Sexual Maturity Status Response 368 | 2022-03-25 Update C156784 CDISC Codelist Name MISXMAT Microscopy Sexual Maturity Status Response Update CDISC Codelist Name Microscopy Sexual Maturity Status Microscopy Sexual Maturity Status Response 369 | 2022-03-25 Update C176226 CDISC Codelist Name MISXMAT Microscopy Sexual Maturity Status Response Update CDISC Codelist Name Microscopy Sexual Maturity Status Microscopy Sexual Maturity Status Response 370 | 2022-03-25 Update C176226 CDISC Synonym MISXMAT Microscopy Sexual Maturity Status Response Add new CDISC Synonym - - - Microscopy Sexual Maturity Status Response 371 | 2022-03-25 Update C176226 CDISC Synonym MISXMAT Microscopy Sexual Maturity Status Response Remove CDISC Synonym Microscopy Sexual Maturity Status - - - 372 | 2022-03-25 Update C176390 CDISC Codelist Name MISXMAT Microscopy Sexual Maturity Status Response Update CDISC Codelist Name Microscopy Sexual Maturity Status Microscopy Sexual Maturity Status Response 373 | 2022-03-25 Add C186257 Term MITEST SEND Microscopic Findings Test Name Add new term to existing codelist - - - ReproCycle Phase Microscopic Exam, Qual 374 | 2022-03-25 Add C186257 Term MITESTCD SEND Microscopic Findings Test Code Add new term to existing codelist - - - RCPMIQL 375 | 2022-03-25 Update C4115 CDISC Submission Value NEOPLASM Neoplasm Type Update CDISC Submission Value PAPILLOMA, TRANSITIONAL CELL, BENIGN PAPILLOMA, UROTHELIAL CELL, BENIGN 376 | 2022-03-25 Update C4115 CDISC Definition NEOPLASM Neoplasm Type Update CDISC Definition A benign papillary neoplasm composed of transitional cells. A benign papillary neoplasm composed of urothelial cells. 377 | 2022-03-25 Update C4115 CDISC Synonym NEOPLASM Neoplasm Type Add new CDISC Synonym - - - Transitional Cell Papilloma 378 | 2022-03-25 Add C4525 Term NEOPLASM Neoplasm Type Add new term to existing codelist - - - SARCOMA, RENAL, MALIGNANT 379 | 2022-03-25 Update C38938 NCI Preferred Term NEOPLASM Neoplasm Type Update NCI Preferred Term Grade III Meningioma Grade 3 Meningioma 380 | 2022-03-25 Add C3014 Term NONNEO Non-Neoplastic Finding Type Add new term to existing codelist - - - ENDOMETRIOSIS 381 | 2022-03-25 Update C105467 CDISC Definition PKUDMG PK Units of Measure - Dose mg Update CDISC Definition Hours times micrograms per milliliter (area under the curve), divided by milligrams per kilogram per day (daily dose normalized by body weight). Hour times nanograms per milliliter (area under the curve), divided by micrograms per kilogram per day (daily dose normalized by body weight), or hour times micrograms per milliliter (area under the curve), divided by milligrams per kilogram per day (daily dose normalized by body weight). 382 | 2022-03-25 Update C105467 CDISC Synonym PKUDMG PK Units of Measure - Dose mg Add new CDISC Synonym - - - h*ng/mL/(ug/kg/day) 383 | 2022-03-25 Update C105467 CDISC Synonym PKUDMG PK Units of Measure - Dose mg Add new CDISC Synonym - - - h*ug/mL/(mg/kg/day) 384 | 2022-03-25 Add C105467 Term PKUDUG PK Units of Measure - Dose ug Add new term to existing codelist - - - h*ng/mL/(ug/kg/day) 385 | 2022-03-25 Update C105467 CDISC Definition PKUNIT PK Units of Measure Update CDISC Definition Hours times micrograms per milliliter (area under the curve), divided by milligrams per kilogram per day (daily dose normalized by body weight). Hour times nanograms per milliliter (area under the curve), divided by micrograms per kilogram per day (daily dose normalized by body weight), or hour times micrograms per milliliter (area under the curve), divided by milligrams per kilogram per day (daily dose normalized by body weight). 386 | 2022-03-25 Update C105467 CDISC Synonym PKUNIT PK Units of Measure Add new CDISC Synonym - - - h*ng/mL/(ug/kg/day) 387 | 2022-03-25 Update C105467 CDISC Synonym PKUNIT PK Units of Measure Add new CDISC Synonym - - - h*ug/mL/(mg/kg/day) 388 | 2022-03-25 Update C120917 CDISC Synonym SCVTST SEND Cardiovascular Test Name Add new CDISC Synonym - - - -dP/dt 389 | 2022-03-25 Update C120917 CDISC Synonym SCVTST SEND Cardiovascular Test Name Add new CDISC Synonym - - - Left Ventricular Maximum Negative dP/dt 390 | 2022-03-25 Update C120917 CDISC Synonym SCVTST SEND Cardiovascular Test Name Remove CDISC Synonym dPdt Minimum - - - 391 | 2022-03-25 Remove C120918 Term SCVTST SEND Cardiovascular Test Name Remove term entirely from codelist Left Ventricular Maximum Negative dP/dt - - - 392 | 2022-03-25 Add C168125 Term SCVTST SEND Cardiovascular Test Name Add new term to existing codelist - - - Capillary Refill Time 393 | 2022-03-25 Add C186258 Term SCVTST SEND Cardiovascular Test Name Add new term to existing codelist - - - Contractility Index 394 | 2022-03-25 Add C186259 Term SCVTST SEND Cardiovascular Test Name Add new term to existing codelist - - - Left Ventricular Positive dP/dt 40mmHg 395 | 2022-03-25 Update C120917 CDISC Synonym SCVTSTCD SEND Cardiovascular Test Code Add new CDISC Synonym - - - -dP/dt 396 | 2022-03-25 Update C120917 CDISC Synonym SCVTSTCD SEND Cardiovascular Test Code Add new CDISC Synonym - - - Left Ventricular Maximum Negative dP/dt 397 | 2022-03-25 Update C120917 CDISC Synonym SCVTSTCD SEND Cardiovascular Test Code Remove CDISC Synonym dPdt Minimum - - - 398 | 2022-03-25 Remove C120918 Term SCVTSTCD SEND Cardiovascular Test Code Remove term entirely from codelist DPDTNEG - - - 399 | 2022-03-25 Add C168125 Term SCVTSTCD SEND Cardiovascular Test Code Add new term to existing codelist - - - CPLRFLT 400 | 2022-03-25 Add C186258 Term SCVTSTCD SEND Cardiovascular Test Code Add new term to existing codelist - - - CI 401 | 2022-03-25 Add C186259 Term SCVTSTCD SEND Cardiovascular Test Code Add new term to existing codelist - - - DPDT40 402 | 2022-03-25 Add C42872 Term SEPOCH SEND Epoch Add new term to new codelist - - - WASHOUT 403 | 2022-03-25 Add C101526 Term SEPOCH SEND Epoch Add new term to new codelist - - - TREATMENT 404 | 2022-03-25 Add C185849 CDISC Codelist SEPOCH SEND Epoch Addition of new codelist - - - SEPOCH 405 | 2022-03-25 Add C186260 Term SEPOCH SEND Epoch Add new term to new codelist - - - CHALLENGE 406 | 2022-03-25 Add C186261 Term SEPOCH SEND Epoch Add new term to new codelist - - - RECOVERY 407 | 2022-03-25 Add C186262 Term SEPOCH SEND Epoch Add new term to new codelist - - - TREATMENT FREE 408 | 2022-03-25 Add C186271 Term SEPOCH SEND Epoch Add new term to new codelist - - - PRE-TREATMENT 409 | 2022-03-25 Update C12292 CDISC Synonym SPEC Specimen Add new CDISC Synonym - - - Pinna 410 | 2022-03-25 Update C12473 CDISC Synonym SPEC Specimen Add new CDISC Synonym - - - Synovial Membrane 411 | 2022-03-25 Update C12473 CDISC Synonym SPEC Specimen Add new CDISC Synonym - - - Synovial Stratum 412 | 2022-03-25 Update C12698 CDISC Synonym SPEC Specimen Add new CDISC Synonym - - - Common Duct 413 | 2022-03-25 Update C12698 CDISC Synonym SPEC Specimen Add new CDISC Synonym - - - Common Hepatic Duct 414 | 2022-03-25 Add C12751 Term SPEC Specimen Add new term to existing codelist - - - BONE, METACARPAL 415 | 2022-03-25 Add C12752 Term SPEC Specimen Add new term to existing codelist - - - BONE, METATARSAL 416 | 2022-03-25 Update C32874 CDISC Synonym SPEC Specimen Add new CDISC Synonym - - - Ventricular Septum 417 | 2022-03-25 Remove C90476 Term SPEC Specimen Remove term entirely from codelist ALL TISSUES - - - 418 | 2022-03-25 Add C186263 Term SRETST SEND Respiratory Test Name Add new term to existing codelist - - - Minute Volume per Kilogram 419 | 2022-03-25 Add C186264 Term SRETST SEND Respiratory Test Name Add new term to existing codelist - - - Peak Expiratory Flow per Kilogram 420 | 2022-03-25 Add C186265 Term SRETST SEND Respiratory Test Name Add new term to existing codelist - - - Peak Inspiratory Flow per Kilogram 421 | 2022-03-25 Add C186266 Term SRETST SEND Respiratory Test Name Add new term to existing codelist - - - Tidal Volume per Kilogram 422 | 2022-03-25 Add C186263 Term SRETSTCD SEND Respiratory Test Code Add new term to existing codelist - - - MVKG 423 | 2022-03-25 Add C186264 Term SRETSTCD SEND Respiratory Test Code Add new term to existing codelist - - - PEFKG 424 | 2022-03-25 Add C186265 Term SRETSTCD SEND Respiratory Test Code Add new term to existing codelist - - - PIFKG 425 | 2022-03-25 Add C186266 Term SRETSTCD SEND Respiratory Test Code Add new term to existing codelist - - - TDVOLKG 426 | 2022-03-25 Add C186267 Term STCNTRL SEND Control Type Add new term to existing codelist - - - BLOCK CONTROL 427 | 2022-03-25 Update C68667 CDISC Synonym UNIT Unit Add new CDISC Synonym - - - Degrees 428 | 2022-03-25 Remove C101687 Term UNIT Unit Remove term entirely from codelist NEEDLE GAUGE - - - 429 | 2022-03-25 Add C111984 Term UNIT Unit Add new term to existing codelist - - - PUMP 430 | 2022-03-25 Add C122634 Term UNIT Unit Add new term to existing codelist - - - PILL 431 | 2022-03-25 Add C166082 Term UNIT Unit Add new term to existing codelist - - - ngEq/g 432 | 2022-03-25 Add C184705 Term UNIT Unit Add new term to existing codelist - - - ngEq 433 | 2022-03-25 Add C186219 Term UNIT Unit Add new term to existing codelist - - - APS U/mL 434 | 2022-03-25 Add C186220 Term UNIT Unit Add new term to existing codelist - - - ENVELOPE 435 | 2022-03-25 Add C186221 Term UNIT Unit Add new term to existing codelist - - - GPS U/mL 436 | 2022-03-25 Add C186222 Term UNIT Unit Add new term to existing codelist - - - GUMMY 437 | 2022-03-25 Add C186223 Term UNIT Unit Add new term to existing codelist - - - MPS U/mL 438 | 2022-03-25 Add C186224 Term UNIT Unit Add new term to existing codelist - - - Therapeutic Cells/m2 439 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/previous/ADaM Terminology.txt: -------------------------------------------------------------------------------- 1 | Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term 2 | C81223 No Date Imputation Flag DATEFL Date Imputation Flag Date Imputation Flag: Indicates the level of imputation reflected in a date value. CDISC ADaM Date Imputation Flag Terminology 3 | C81212 C81223 Date Imputation Flag D Day Imputed: Day is imputed. Day Imputed 4 | C81211 C81223 Date Imputation Flag M Month Imputed: Month and day are imputed. Month Day Imputed 5 | C81210 C81223 Date Imputation Flag Y Year Imputed: Entire date (year, month and day) is imputed. Year Month Day Imputed 6 | C81224 Yes Derivation Type DTYPE Derivation Type Derivation Type: Analysis value derivation method. CDISC ADaM Derivation Type Terminology 7 | C81209 C81224 Derivation Type AVERAGE Average A data derivation or imputation technique which sets the analysis value on the record to the subject's average value over a defined set of records. Average of Value Derivation Technique 8 | C92225 C81224 Derivation Type BC Best Case A data derivation or imputation technique which sets the analysis value on the record to the best possible outcome. Best Case Imputation Technique 9 | C81201 C81224 Derivation Type BLOCF Baseline Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's non-missing baseline observation. Baseline Observation Carried Forward Imputation Technique 10 | C132340 C81224 Derivation Type BOC Best Observed Case A data derivation or imputation technique which sets the analysis value on the record to the best outcome recorded within a subject. Best Observed Case Imputation Technique 11 | C92226 C81224 Derivation Type BOCF Best Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's previous best-case non-missing value. Best Observation Carried Forward Imputation Technique 12 | C184383 C81224 Derivation Type COPY A technique that uses assignment logic to duplicate an analysis value to be used in additional evaluations. Copy Duplication Imputation Technique 13 | C139176 C81224 Derivation Type EXTRAP Extrapolation A data derivation or imputation technique which sets the analysis value on the record to an estimation of a value based on extending a known sequence of values. Extrapolation Imputation Technique 14 | C170546 C81224 Derivation Type HALFLLOQ One Half of Lower Limit of Quantification A data derivation or imputation technique which sets the analysis value on the record to one half of the lower limit of quantification of a test. One Half of Lower Limit of Quantification Derivation Technique 15 | C81208 C81224 Derivation Type INTERP Interpolation A data derivation or imputation technique which sets the analysis value on the record to a function of known values to estimate a value within the range. Interpolation Imputation Technique 16 | C105701 C81224 Derivation Type LLOD Lower Limit of Detection A data derivation or imputation technique which sets the analysis value on the record to the lower limit of detection of a test. Detection Limit 17 | C170543 C81224 Derivation Type LLOQ Lower Limit of Quantification A data derivation or imputation technique which sets the analysis value on the record to the lower limit of quantification of a test. Lower Limit of Quantification Derivation Technique 18 | C81198 C81224 Derivation Type LOCF Last Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's previous non-missing value. Last Observation Carried Forward Imputation Technique 19 | C132341 C81224 Derivation Type LOV Last Observed Value A data derivation or imputation technique which sets the analysis value on the record to the subject's last recorded non-missing observation. Last Observed Value Imputation Technique 20 | C132342 C81224 Derivation Type LVPD Last Value Prior to Dosing A data derivation or imputation technique which sets the analysis value on the record to the subject's last observed value prior to the start of study treatment. Last Value Prior to Dosing Imputation Technique 21 | C82868 C81224 Derivation Type MAXIMUM Maximum A data derivation or imputation technique which sets the analysis value on the record to the subject's maximum value over a defined set of records. Maximum Value Derivation Technique 22 | C82867 C81224 Derivation Type MINIMUM Minimum A data derivation or imputation technique which sets the analysis value on the record to the subject's minimum value over a defined set of records. Minimum Value Derivation Technique 23 | C53331 C81224 Derivation Type ML Maximum Likelihood A data derivation or imputation technique which sets the analysis value on the record to the estimate that maximizes the probability of observing what has in fact been observed. Maximum Likelihood Estimation 24 | C81204 C81224 Derivation Type MOTH Mean of Other Group A data derivation or imputation technique which sets the analysis value on the record to the mean value from a comparator or reference group. Mean of Other Group Imputation Technique 25 | C81207 C81224 Derivation Type MOV Mean Observed Value in a Group A data derivation or imputation technique which sets the analysis value on the record to the mean value observed in a group of subjects. Mean Observed Value in a Group Imputation Technique 26 | C170545 C81224 Derivation Type PHANTOM Phantom Record A technique that creates a record with a missing analysis value when there is no observed record for a given analysis visit or analysis timepoint. Phantom Record Imputation Technique 27 | C81205 C81224 Derivation Type POCF Penultimate Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's next-to-last non-missing value. Penultimate Observation Carried Forward Imputation Technique 28 | C81200 C81224 Derivation Type SOCF Screening Observation Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's non-missing screening observation. Screening Observation Carried Forward Imputation Technique 29 | C174264 C81224 Derivation Type ULOD Upper Limit of Detection A data derivation or imputation technique which sets the analysis value on the record to the upper limit of detection of a test. Upper Limit of Detection Imputation Technique 30 | C170544 C81224 Derivation Type ULOQ Upper Limit of Quantification A data derivation or imputation technique which sets the analysis value on the record to the upper limit of quantification of a test. Upper Limit of Quantification Derivation Technique 31 | C81203 C81224 Derivation Type WC Worst Case A data derivation or imputation technique which sets the analysis value on the record to the worst possible outcome. Worst Case Imputation Technique 32 | C132343 C81224 Derivation Type WOC Worst Observed Case A data derivation or imputation technique which sets the analysis value on the record to the worst recorded outcome within a subject. Worst Observed Case Imputation Technique 33 | C81199 C81224 Derivation Type WOCF Worst Observed Value Carried Forward A data derivation or imputation technique which sets the analysis value on the record to the subject's worst-case non-missing observation. Worst Observation Carried Forward Imputation Technique 34 | C81206 C81224 Derivation Type WOV Worst Observed Value in a Group A data derivation or imputation technique which sets the analysis value on the record to the worst value observed in a group of subjects. Worst Observed Value in a Group Imputation Technique 35 | C172334 No Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Code GAD02PC Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Code A parameter code codelist for the Generalized Anxiety Disorder - 7 Version 2 Questionnaire (GAD-7 V2) to support the calculation of total score in ADaM. CDISC ADaM Generalized Anxiety Disorder-7 Version 2 Questionnaire Parameter Code Terminology 36 | C172451 C172334 Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Code GAD02TS GAD02-Total Score - Analysis Generalized Anxiety Disorder - 7 Version 2 - Total score used for analysis. Generalized Anxiety Disorder - 7 Version 2 - Analysis 37 | C172335 No Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Name GAD02PN Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Name A parameter name codelist for the Generalized Anxiety Disorder - 7 Version 2 Questionnaire (GAD-7 V2) to support the calculation of total score in ADaM. CDISC ADaM Generalized Anxiety Disorder-7 Version 2 Questionnaire Parameter Name Terminology 38 | C172451 C172335 Generalized Anxiety Disorder - 7 Version 2 Questionnaire Parameter Name GAD02-Total Score - Analysis GAD02-Total Score - Analysis Generalized Anxiety Disorder - 7 Version 2 - Total score used for analysis. Generalized Anxiety Disorder - 7 Version 2 - Analysis 39 | C158114 No Geriatric Depression Scale Short Form Questionnaire Parameter Code GDS02PC Geriatric Depression Scale Short Form Questionnaire Parameter Code A parameter code codelist for the Geriatric Depression Scale Short Form questionnaire (GDS02) to support the calculation of total score in ADaM. CDISC ADaM Geriatric Depression Scale Short Form Questionnaire Parameter Code Terminology 40 | C158155 C158114 Geriatric Depression Scale Short Form Questionnaire Parameter Code GDS02TS GDS02-Total Score - Analysis Geriatric Depression Scale Short Form - Total score used for analysis. Geriatric Depression Scale Short Form - Total Score 41 | C158115 No Geriatric Depression Scale Short Form Questionnaire Parameter Name GDS02PN Geriatric Depression Scale Short Form Questionnaire Parameter Name A parameter name codelist for the Geriatric Depression Scale Short Form questionnaire (GDS02) to support the calculation of total score in ADaM. CDISC ADaM Geriatric Depression Scale Short Form Questionnaire Parameter Name Terminology 42 | C158155 C158115 Geriatric Depression Scale Short Form Questionnaire Parameter Name GDS02-Total Score - Analysis GDS02-Total Score - Analysis Geriatric Depression Scale Short Form - Total score used for analysis. Geriatric Depression Scale Short Form - Total Score 43 | C81225 No Parameter Type PARAMTYP Parameter Type Parameter Type: Indicates whether the parameter is derived as a function of one or more other parameters. CDISC ADaM Parameter Type Terminology 44 | C81197 C81225 Parameter Type DERIVED Derived: Indicates that a parameter is derived as a function of one or more other parameters. Derived Flag 45 | C165644 Yes Pool for Integration POOLINT Pool for Integration Terminology relevant to the name of the Pool, often defined in the integrated statistical analysis plan, which identifies the combination of subjects' clinical trial experience and will be the focus of the integrated analysis. CDISC ADaM Pool for Integration Terminology 46 | C165858 C165644 Pool for Integration OVERALL The pool that includes data across all studies within which the subject has participated, used for the overall integrated analysis. Overall Pooled Data 47 | C124296 Yes Subject Trial Status SBJTSTAT Subject Trial Status Indicates the status of the subject in the trial. CDISC ADaM Subject Trial Status Terminology 48 | C25250 C124296 Subject Trial Status COMPLETED To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI) Complete 49 | C25484 C124296 Subject Trial Status DISCONTINUED To stop or end, permanently or temporarily. Discontinue 50 | C53279 C124296 Subject Trial Status ONGOING Continuous Remain in force or carry on without letup; keep or maintain in unaltered condition; exist in time or space without stop or interruption. (NCI) Continue 51 | C81226 No Time Imputation Flag TIMEFL Time Imputation Flag Time Imputation Flag: Indicates the level of imputation reflected in a time value. CDISC ADaM Time Imputation Flag Terminology 52 | C81213 C81226 Time Imputation Flag H Hours Imputed: Entire time (hours, minutes and seconds) is imputed. Hours Minutes Seconds Imputed 53 | C81214 C81226 Time Imputation Flag M Minutes Imputed: Minutes and seconds are imputed. Minutes Seconds Imputed 54 | C81215 C81226 Time Imputation Flag S Seconds Imputed: Seconds are imputed. Seconds Imputed 55 | -------------------------------------------------------------------------------- /test/resources/fixtures/report-files/previous/Define-XML Terminology.txt: -------------------------------------------------------------------------------- 1 | Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term 2 | C165635 No ADaM Basic Data Structure Subclass BDSSC ADaM Basic Data Structure Subclass Terminology relevant to the subclasses of the ADaM basic data structure. CDISC Define-XML ADaM Basic Data Structure Subclass Terminology 3 | C172452 C165635 ADaM Basic Data Structure Subclass NON-COMPARTMENTAL ANALYSIS NCA A dataset containing data that is used for non-compartmental analyses. Non-Compartmental Analysis Dataset 4 | C165637 C165635 ADaM Basic Data Structure Subclass TIME-TO-EVENT TTE A dataset containing data that is used for Time-to-Event analyses. Time-to-Event Dataset 5 | C177903 No ADaM Medical Device Basic Data Structure Subclass MDBDSSC ADaM Medical Device Basic Data Structure Subclass Terminology relevant to the subclasses of the ADaM device level basic data structure. CDISC Define-XML ADaM Medical Device Basic Data Structure Subclass Terminology 6 | C177920 C177903 ADaM Medical Device Basic Data Structure Subclass MEDICAL DEVICE TIME-TO-EVENT MDTTE A dataset containing data that is used for medical device Time-to-Event analyses. Medical Device Time-to-Event Dataset 7 | C176227 No ADaM Occurrence Data Structure Subclass OCCSC ADaM Occurrence Data Structure Subclass Terminology relevant to the subclasses of the ADaM occurrence data structure. CDISC Define-XML ADaM Occurrence Data Structure Subclass Terminology 8 | C176265 C176227 ADaM Occurrence Data Structure Subclass ADVERSE EVENT A dataset containing data that is used for adverse event analyses. Adverse Event Dataset 9 | C117745 Yes Analysis Purpose ANLPURP Analysis Purpose Purpose of a specific analysis result described in Define-XML analysis results metadata. CDISC Define-XML Analysis Purpose Terminology 10 | C98724 C117745 Analysis Purpose EXPLORATORY OUTCOME MEASURE Exploratory Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure 11 | C98772 C117745 Analysis Purpose PRIMARY OUTCOME MEASURE Primary Outcome Measure The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure 12 | C98781 C117745 Analysis Purpose SECONDARY OUTCOME MEASURE Secondary Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure 13 | C117744 Yes Analysis Reason ANLREAS Analysis Reason Reason for reporting a specific analysis result described in Define-XML analysis results metadata. CDISC Define-XML Analysis Reason Terminology 14 | C117750 C117744 Analysis Reason DATA DRIVEN The analysis was triggered by findings in the data. Data Driven Analysis 15 | C117751 C117744 Analysis Reason REQUESTED BY REGULATORY AGENCY The analysis has been requested by a regulatory agency. Analysis Requested by Regulatory Agency 16 | C117752 C117744 Analysis Reason SPECIFIED IN PROTOCOL The analysis is specified in a protocol. Analysis Specified in Protocol 17 | C117753 C117744 Analysis Reason SPECIFIED IN SAP The analysis is specified in a statistical analysis plan. Analysis Specified in Statistical Analysis Plan 18 | C172331 No CDISC Controlled Terminology Standard Type CTSTDTYP CDISC Controlled Terminology Standard Type Terminology relevant to the classification of the CDISC controlled terminology standard described in the Define-XML document. CDISC Define-XML CDISC Controlled Terminology Standard Type Terminology 19 | C180548 C172331 CDISC Controlled Terminology Standard Type ADaM The controlled terminology standard subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model (ADaM). CDISC ADaM Standard Terminology 20 | C180549 C172331 CDISC Controlled Terminology Standard Type CDASH The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Clinical Data Acquisition Standards Harmonization (CDASH) group. CDISC CDASH Standard Terminology 21 | C180550 C172331 CDISC Controlled Terminology Standard Type DEFINE-XML The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Define-XML standard. CDISC Define-XML Standard Terminology 22 | C180551 C172331 CDISC Controlled Terminology Standard Type SDTM The controlled terminology standard subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). CDISC SDTM Standard Terminology 23 | C180552 C172331 CDISC Controlled Terminology Standard Type SEND The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Non-clinical Data (SEND) group. CDISC SEND Standard Terminology 24 | C66788 Yes Dictionary Name DICTNAM Dictionary Name A name given to a reference source that lists words and gives their meaning. (NCI) CDISC Dictionary Name Terminology 25 | C163415 C66788 Dictionary Name CDISC CT CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology 26 | C49471 C66788 Dictionary Name COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms A terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI) Thesaurus of Adverse Reaction Term Coding Symbols 27 | C49704 C66788 Dictionary Name CTCAE Common Terminology Criteria for Adverse Events A standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. Common Terminology Criteria for Adverse Events 28 | C134003 C66788 Dictionary Name D-U-N-S NUMBER Data Universal Number System; DUNS Numbers A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. Data Universal Numbering System 29 | C49474 C66788 Dictionary Name ICD International Classification of Diseases A system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12) International Classification of Diseases 30 | C49476 C66788 Dictionary Name LOINC Logical Observation Identifiers Names and Codes Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI) Logical Observation Identifiers Names and Codes 31 | C163416 C66788 Dictionary Name MED-RT Medication Reference Terminology; NDF-RT A standard terminology developed and maintained by the Veterans Health Administration (VHA) that includes terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of medications. MED-RT incorporates terminology from RxNORM, MeSH, and SNOMED CT. Medication Reference Terminology 32 | C43820 C66788 Dictionary Name MedDRA Medical Dictionary for Regulatory Activities MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI) MedDRA 33 | C53489 C66788 Dictionary Name SNOMED Systematized Nomenclature of Medicine A multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI) Systematized Nomenclature of Medicine 34 | C163417 C66788 Dictionary Name UNII SRS-UNII; Substance Registration System-Unique Ingredient Identifier A standard terminology developed and maintained by the Department of Veterans Affairs/Veterans Health Administration designated federal collaborative Structured Product Labeling Interagency Expert Panel (SPLIEP). It contains terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of drug ingredients and food allergens. Substance Registration System-Unique Ingredient Identifier 35 | C154331 C66788 Dictionary Name WHO ATC CLASSIFICATION SYSTEM Anatomical Therapeutic Chemical Classification System A World Health Organization (WHO) classification system, developed and maintained by the WHO Collaborating Centre for Drug Statistics Methodology, for medicinal substances where active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological, and chemical properties. Anatomical Therapeutic Chemical Classification System 36 | C49468 C66788 Dictionary Name WHOART World Health Organization Adverse Reaction Terms A terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI) World Health Organization Adverse Reaction Terminology 37 | C49475 C66788 Dictionary Name WHODD WHODrug Global; World Health Organization Drug Dictionary A reference source of drugs and drug associated information maintained by the World Health Organization. (NCI) World Health Organization Drug Dictionary 38 | C103329 No General Observation Class GNRLOBSC General Observation Class Terminology related to the classification of a CDISC domain. CDISC Define-XML General Observation Class Terminology 39 | C103375 C103329 General Observation Class ADAM OTHER ADaM Other An analysis dataset that doesn't conform to a pre-defined ADaM dataset structure (e.g. ADSL, BDS or OCCDS). CDISC Other ADaM Dataset 40 | C103371 C103329 General Observation Class BASIC DATA STRUCTURE Basic Data Structure; BDS An ADaM BDS dataset contains one or more records per subject, per analysis parameter, per analysis time point. Variables include the value being analyzed (e.g., AVAL) and the description of the value being analyzed (e.g., PARAM). Other variables in the dataset provide more information about the value being analyzed (e.g., the subject identification) or describe and trace the derivation of it (e.g., DTYPE) or support the analysis of it (e.g., treatment variables, covariates). CDISC Basic Data Structure Dataset 41 | C177921 C103329 General Observation Class DEVICE LEVEL ANALYSIS DATASET ADDL; Device Level Analysis Dataset The Device-Level Analysis Dataset (ADDL) is a one-record-per-device or one-record-per-subject-per-device dataset which contains variables that describe device characteristics and timing, and group the devices for analysis. ADDL is the primary source for device-level variables included in other analysis datasets. CDISC Device Level Analysis Dataset 42 | C103372 C103329 General Observation Class EVENTS Events This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). CDISC Events Class 43 | C135396 C103329 General Observation Class FINDINGS ABOUT Findings About This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. CDISC Findings About Class 44 | C103373 C103329 General Observation Class FINDINGS Findings This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. CDISC Findings Class 45 | C103374 C103329 General Observation Class INTERVENTIONS Interventions This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). CDISC Interventions Class 46 | C177922 C103329 General Observation Class MEDICAL DEVICE BASIC DATA STRUCTURE MDBDS; Medical Device Basic Data Structure The Medical Device Basic Data Structure (MDBDS) supports the analysis needs by adding SPDEVID as a required key variable and USUBJID a conditionally required variable. See the BDS class for further details. CDISC Medical Device Basic Data Structure 47 | C177923 C103329 General Observation Class MEDICAL DEVICE OCCURRENCE DATA STRUCTURE MDOCCDS; Medical Device Occurrence Data Structure The Medical Device Occurrence Data Structure (MDOCCDS) supports the analysis needs by adding SPDEVID as a required identifier and allowing USUBJID be a conditionally required variable. See the OCCDS class for further details. CDISC Medical Device Occurrence Data Structure 48 | C123454 C103329 General Observation Class OCCURRENCE DATA STRUCTURE OCCDS; Occurrence Data Structure The Occurrence Data Structure (OCCDS) is the ADaM data structure for occurrence analysis. Occurrence analysis is the counting of subjects with a record or term, and often includes a structured hierarchy of dictionary coding categories. CDISC Occurrence Data Structure 49 | C103376 C103329 General Observation Class RELATIONSHIP Relationships This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets. CDISC Relationship Class 50 | C103377 C103329 General Observation Class SPECIAL PURPOSE Special Purpose; SPECIAL-PURPOSE This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV. CDISC Special Purpose Class 51 | C147271 C103329 General Observation Class STUDY REFERENCE Study Reference This special purpose SDTM class contains further descriptions of study-specific identifiers that will be used in subject based domains. CDISC Study Reference Class 52 | C103378 C103329 General Observation Class SUBJECT LEVEL ANALYSIS DATASET ADSL; Subject Level Analysis Dataset The Subject-Level Analysis Dataset (ADSL) is a one-record-per-subject dataset which contains variables that describe subject demographic characteristics and group the subjects for analysis. ADSL is the primary source for subject-level variables included in other analysis datasets such as population flags and treatment variables. CDISC Subject Level Analysis Dataset 53 | C103379 C103329 General Observation Class TRIAL DESIGN Trial Design This SDTM class describes the plan for the procedures to be followed in a clinical trial, including planned and actual timing of events, control group, method of allocating treatments, blinding methods, assignment of epochs that subjects pass through in the course of a trial. CDISC Trial Design Class 54 | C170448 No ODM Context ODMCNTX ODM Context Terminology relevant to the context in which the Define-XML document is used. CDISC Define-XML ODM Context Terminology 55 | C17649 C170448 ODM Context Other Other Different than the one(s) previously specified or mentioned. (NCI) Other 56 | C70885 C170448 ODM Context Submission An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness. Regulatory Submission 57 | C170450 No Origin Source ORIGINS Origin Source Terminology relevant to the origin source for datasets in the Define-XML document. CDISC Define-XML Origin Source Terminology 58 | C25936 C170450 Origin Source Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principal investigator. Investigator 59 | C70793 C170450 Origin Source Sponsor Clinical Study Sponsor; Sponsor; Study Sponsor An entity that is responsible for the initiation, management, and/or financing of a clinical study. Clinical Study Sponsor 60 | C41189 C170450 Origin Source Subject An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. Study Subject 61 | C68608 C170450 Origin Source Vendor A person or agency that promotes or exchanges goods or services for money. (NCI) Vendor 62 | C170449 No Origin Type ORIGINT Origin Type Terminology relevant to the origin type for datasets in the Define-XML document. CDISC Define-XML Origin Type Terminology 63 | C170547 C170449 Origin Type Assigned A value that is derived through designation, such as values from a look up table or a label on a CRF. Assigned Value 64 | C170548 C170449 Origin Type Collected A value that is actually observed and recorded by a person or obtained by an instrument. Collected Value 65 | C170549 C170449 Origin Type Derived A value that is calculated by an algorithm or reproducible rule, and which is dependent upon other data values. Derived Value 66 | C126101 C170449 Origin Type Not Available A value that is not discoverable or accessible. Not Available 67 | C17649 C170449 Origin Type Other Other Different than the one(s) previously specified or mentioned. (NCI) Other 68 | C170550 C170449 Origin Type Predecessor A value that is copied from a variable in another dataset. Copied Value 69 | C170551 C170449 Origin Type Protocol A value that is included as part of the study protocol. Protocol Value 70 | C170452 No Standard Name STDNAM Standard Name Terminology relevant to the name of the standard described in the Define-XML document. CDISC Define-XML Standard Name Terminology 71 | C170552 C170452 Standard Name ADaMIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard. ADaM Implementation Guide 72 | C163415 C170452 Standard Name CDISC/NCI CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology 73 | C170455 C170452 Standard Name SDTMIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model standard. SDTM Implementation Guide 74 | C170553 C170452 Standard Name SDTMIG-AP The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Associated Persons standard. SDTM Implementation Guide-Associated Persons 75 | C170554 C170452 Standard Name SDTMIG-MD The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Medical Devices standard. SDTM Implementation Guide-Medical Devices 76 | C170456 C170452 Standard Name SENDIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data standard. SEND Implementation Guide 77 | C181230 C170452 Standard Name SENDIG-AR The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Animal Rule standard. SEND Implementation Guide-Animal Rule 78 | C170556 C170452 Standard Name SENDIG-DART The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Developmental and Reproductive Toxicology standard. SEND Implementation Guide-Developmental and Reproductive Toxicology 79 | C172332 Yes Standard Status STDSTAT Standard Status Terminology relevant to the development or publication status of the standard. CDISC Define-XML Standard Status Terminology 80 | C172453 C172332 Standard Status DRAFT A preliminary version of a CDISC standard that has not yet completed the CDISC standards development process. (NCI) CDISC Draft Standard 81 | C172455 C172332 Standard Status FINAL A final version of a CDISC standard that has completed the CDISC standards development process. (NCI) CDISC Final Standard 82 | C172454 C172332 Standard Status PROVISIONAL A version of a CDISC standard whose conclusiveness is dependent upon the fulfillment of some contingency or final alteration. (NCI) CDISC Provisional Standard 83 | C170451 No Standard Type STDTYP Standard Type Terminology relevant to the classification of the standard described in the Define-XML document. CDISC Define-XML Standard Type Terminology 84 | C163415 C170451 Standard Type CT CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology 85 | C170454 C170451 Standard Type IG CDISC Implementation Guide A standard document developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) that contains instructions and requirements for the organization, structure, and format of standard clinical and non-clinical trial tabulation and analysis datasets. CDISC Implementation Guide 86 | -------------------------------------------------------------------------------- /test/src/gov/nih/nci/evs/cdisc/DiffTest.java: -------------------------------------------------------------------------------- 1 | package gov.nih.nci.evs.cdisc; 2 | 3 | import org.apache.commons.io.IOUtils; 4 | import org.junit.jupiter.api.io.TempDir; 5 | import org.junit.jupiter.params.ParameterizedTest; 6 | import org.junit.jupiter.params.provider.CsvSource; 7 | 8 | import java.io.File; 9 | import java.io.IOException; 10 | import java.net.URISyntaxException; 11 | import java.nio.charset.Charset; 12 | import java.nio.file.Path; 13 | import java.time.LocalDate; 14 | 15 | import static java.lang.String.format; 16 | import static org.assertj.core.api.Assertions.assertThat; 17 | 18 | public class DiffTest { 19 | @TempDir 20 | public File outFolder; 21 | 22 | @ParameterizedTest 23 | @CsvSource({ 24 | "ADaM Terminology", 25 | "CDASH Terminology", 26 | "Define-XML Terminology", 27 | "Glossary Terminology", 28 | "Protocol Terminology", 29 | "QRS Terminology", 30 | "SDTM Terminology", 31 | "SEND Terminology" 32 | }) 33 | public void testPrint(String conceptFilePrefix, @TempDir Path tempDir) throws IOException, URISyntaxException { 34 | Path outFile = tempDir.resolve(format("%s-changes.txt", conceptFilePrefix)); 35 | Diff diff = new Diff(); 36 | String newReport = new File(getClass().getResource(format("/fixtures/report-files/current/%s.txt", conceptFilePrefix)).toURI()).getPath(); 37 | String oldReport = new File(getClass().getResource(format("/fixtures/report-files/previous/%s.txt", conceptFilePrefix)).toURI()).getPath(); 38 | diff.init(newReport, oldReport, "2022-03-25", outFile.toString()); 39 | diff.getChanges(); 40 | diff.print(); 41 | assertThat(outFile) 42 | .hasContent( 43 | IOUtils.toString( 44 | getClass().getResourceAsStream(format("/fixtures/report-files/expected/%s Changes.txt", conceptFilePrefix)), Charset.defaultCharset())); 45 | 46 | } 47 | } 48 | --------------------------------------------------------------------------------