├── images
    └── CRF.png
├── examples
    ├── acrf.pdf
    ├── bcrf.pdf
    ├── logo.png
    ├── define.pdf
    ├── Test Trial acrf.pdf
    ├── Test Trial bcrf.pdf
    ├── Test Trial book.pdf
    ├── Test Trial spec.pdf
    ├── Test Trial, SDTM-IG3.2.pdf
    └── Test Trial bcrf.html
├── LICENSE
├── files
    ├── cdisc-xml.php
    ├── cdisc-xml.html
    ├── cdisc xml.html
    └── crf_1_3_2.xsl
├── README.md
└── CRF_renditions.md


/images/CRF.png:
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/examples/Test Trial book.pdf:
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/examples/Test Trial spec.pdf:
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/examples/Test Trial, SDTM-IG3.2.pdf:
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/LICENSE:
--------------------------------------------------------------------------------
 1 | MIT License
 2 | 
 3 | Copyright (c) 2020 Jørgen Mangor Iversen
 4 | 
 5 | Permission is hereby granted, free of charge, to any person obtaining a copy
 6 | of this software and associated documentation files (the "Software"), to deal
 7 | in the Software without restriction, including without limitation the rights
 8 | to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
 9 | copies of the Software, and to permit persons to whom the Software is
10 | furnished to do so, subject to the following conditions:
11 | 
12 | The above copyright notice and this permission notice shall be included in all
13 | copies or substantial portions of the Software.
14 | 
15 | THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
16 | IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
17 | FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
18 | AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
19 | LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
20 | OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
21 | SOFTWARE.
22 | 


--------------------------------------------------------------------------------
/files/cdisc-xml.php:
--------------------------------------------------------------------------------
 1 | <?php
 2 | /*
 3 |   Copyright (c) 2022 Jørgen Mangor Iversen
 4 | 
 5 |   Permission is hereby granted, free of charge, to any person obtaining a copy
 6 |   of this software and associated documentation files (the "Software"), to deal
 7 |   in the Software without restriction, including without limitation the rights
 8 |   to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
 9 |   copies of the Software, and to permit persons to whom the Software is
10 |   furnished to do so, subject to the following conditions:
11 | 
12 |   The above copyright notice and this permission notice shall be included in all
13 |   copies or substantial portions of the Software.
14 | 
15 |   THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
16 |   IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
17 |   FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
18 |   AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
19 |   LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
20 |   OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
21 |   SOFTWARE.
22 | */
23 |   error_reporting(0);
24 |   header('Cache-Control: no-cache, no-store, must-revalidate');
25 |   header('Pragma: no-cache');
26 |   header('Expires: 0');
27 | 
28 |   // Upload the XML source from disk
29 |   if (isset($_FILES["parmxml"]) && ($_FILES["parmxml"]["error"] == UPLOAD_ERR_OK))
30 |     $xml = simplexml_load_file($_FILES["parmxml"]["tmp_name"]);
31 |   // Upload the translating style sheet from server
32 |   if (isset($_FILES["parmxsl"]) && ($_FILES["parmxsl"]["error"] == UPLOAD_ERR_OK))
33 |     $xsl = simplexml_load_file($_FILES["parmxsl"]["tmp_name"]);
34 | 
35 |   // Upload logo image file from disk
36 |   if (isset($_FILES["parmlogo"]) && ($_FILES["parmlogo"]["error"] == UPLOAD_ERR_OK))
37 |     $logo = base64_encode(file_get_contents($_FILES["parmlogo"]["tmp_name"]));
38 | 
39 |   // Configure the transformer
40 |   $proc = new XSLTProcessor();
41 |   $proc->importStyleSheet($xsl); // attach the xsl rules
42 | 
43 |   // XSLT parameters
44 |   $proc->setParameter('', "parmdisplay",            $_POST["parmdisplay"]);
45 |   $proc->setParameter('', "parmname",               $_POST["parmname"]);
46 |   $proc->setParameter('', "parmlogo",               "$logo");
47 |   $proc->setParameter('', "parmstudy",              $_POST["parmstudy"]);
48 |   $proc->setParameter('', "parmversion",            $_POST["parmversion"]);
49 |   $proc->setParameter('', "parmstatus",             $_POST["parmstatus"]);
50 |   $proc->setParameter('', "parmlang",               $_POST["parmlang"]);
51 |   $proc->setParameter('', "parmcdash",              $_POST["parmcdash"]);
52 |   $proc->setParameter('', "parmoids",               $_POST["parmoids"]);
53 |   $proc->setParameter('', "nCodeListItemDisplay",   $_POST["nCodeListItemDisplay"]);
54 |   $proc->setParameter('', "displayMethodsTable",    $_POST["displayMethodsTable"]);
55 |   $proc->setParameter('', "displayCommentsTable",   $_POST["displayCommentsTable"]);
56 |   $proc->setParameter('', "displayPrefix",           $_POST["displayPrefix"]);
57 |   $proc->setParameter('', "displayLengthDFormatSD", $_POST["displayLengthDFormatSD"]);
58 | 
59 |   // Do the transformation
60 |   echo $proc->transformToXML($xml);
61 | ?>
62 | 


--------------------------------------------------------------------------------
/README.md:
--------------------------------------------------------------------------------
 1 | #### Table of Contents
 2 | * [About The Project](#About_The_Project)
 3 |   * [Built With](#Built_With)
 4 |   * [Versions](#Versions)
 5 | * [Getting Started](#Getting_Started)
 6 |   * [Installation](#Installation)
 7 |      * [Client side rendition](#Client_side)
 8 |      * [Server side rendition](#Server_side)
 9 |   * [crf_1_3_2.xsl](#crf_1_3_2_xsl)
10 | * [Usage](#Usage)
11 | * [Roadmap](#Roadmap)
12 | * [License](#License)
13 | * [Contact](#Contact)
14 | * [Acknowledgements](#Acknowledgements)
15 | 
16 | # About The Project <a name="About_The_Project"/>
17 | This project is to exploit the CDISC ODM standard as [a single source of truth](https://en.wikipedia.org/wiki/Single_source_of_truth) definition of a CRF specification, allowing
18 | 
19 | * Visual inspection of a CRF design directly from an ODM-xml file
20 | * Documentation of the link between the CRF questions and the collected data points through SDTM annotations of the CRF Forms
21 | * Creation of [acrf](/examples/acrf.pdf) and [bcrf](/examples/bcrf.pdf) submission documents including link targets from define-xml
22 | * Elimination of the labor intensive task of manually moving text boxes of SDTM annotations around on the [acrf](/examples/acrf.pdf) document
23 | * Elimination of the even more labor intensive task of identifying CRF page numbers on the [acrf](/examples/acrf.pdf) document for referencing from define-xml, by replacing them with targets for the links from define.xml
24 | * Encouraging ODM-xml files to be used as an import specification to eCRF software
25 | 
26 | The solution is an XML translating style sheet allowing any valid ODM-xml file to be both human and machine readable, without changing the content.
27 | 
28 | See the [CRF_renditions.md](CRF_renditions.md) document for details of the style sheet itself.
29 | 
30 | ## Built With <a name="Built_With"/>
31 | The main component is an XSLT translating style sheet applied to any ODM-xml file of your own. The result is a webpage displaying the CRF Forms, Questions, data to be collected, and SDTM annotations. The webpage can be printed from the browser, also as a PDF file.
32 | 
33 | The secondary component is an HTML file used to link the XML file to the XSL style sheet. The HTML file will run in modern browsers, NOT Internet Explorer. Two versions exist; one showing files residing on a web server, one uploading files and applying a `php` program. Both version apply the same style sheet to the same ODM-xml file, resulting in the same CRF rendition.
34 | 
35 | ## Versions <a name="Versions"/>
36 | This project covers ODM version 1.3.2 only. Other version of ODM-xml files are not expected to work. ODM version 1.0.0 and ODM version 1.1.0 files have been tested, and they don't work.
37 | 
38 | Transformations are done using **<xsl:stylesheet version="1.0">** creating HTML 4.
39 | 
40 | # Getting Started <a name="Getting_Started"/>
41 | Check out examples of [acrf](/examples/acrf.pdf) and [bcrf](/examples/bcrf.pdf) documents to see the results.
42 | 
43 | Try a [live version](https://try2.info/cdisc-xml/cdisc-xml.html) to test your own ODM file, or my supplied [example](/examples/CDISC_ODM_1.3.2_example.xml) ODM file.
44 | 
45 | ## Installation <a name="Installation"/>
46 | Download the files from the [files](/files) folder and place them in the same folder on your web server.
47 | 
48 | To set up the style sheet, you have to decide whether to perform the transformations on the client or on a server.
49 | 
50 | ### Client side rendition <a name="Client_side"/>
51 | The `cdisc xml.html` (no hyphen) file must be placed on a web server in the same folder as your ODM-xml file and the `crf_1_3_2.xsl` translating style sheet. Other XSL/XSLT files can be used as well, particular `define2-0-0.xsl` for displaying define-xml. This file must be obtained from [CDISC](https://www.cdisc.org/). When adding you own XSL/XSLT files to your server, simply add them as an `<option>` line to the `<select>` tag specifying style sheets within the HTML code.
52 | 
53 | ### Server side rendition <a name="Server_side"/>
54 | The `cdisc-xml.html` (with a hyphen) file and the `cdisc-xml.php` file must be placed in the same folder on a webserver. Together these files can apply any XSL/XSLT translating style sheet to any XML file, including, but not limited to, ODM-xml and define-xml.
55 | 
56 | ## crf_1_3_2.xsl <a name="crf_1_3_2_xsl"/>
57 | This document is the central XSL/XSLT translating style sheet to display a valid CDISC ODM-xml file as an SDTM annotated CRF. This technology is supported in any modern browser, and can be used by any XSLT processor supporting XSLT version 1.0. Display of SDTM annotations and other elements can be controlled via parameters to the `crf_1_3_2.xsl` file.
58 | 
59 | # Usage <a name="Usage"/>
60 | The intended procedure is to refresh the ODM-XML file in your favorite ODM tool as it's development progresses, and then repeatedly apply the `crf_1_3_2.xsl` file to see the rendition progress. Please notice that the CRF rendition contains a title page, a live table of contents (links preserved when converted to PDF), a visit matrix if visits are defined in the ODM-xml file, and a separate table per CRF Form. When printing, page breaks separating title page, toc, visit matrix, and Forms, are created.
61 | 
62 | Please notice that file names may be case sensitive on your system. And please observe that browsers may behave slightly different, even when sharing the same browser engine.
63 | 
64 | # Roadmap <a name="Roadmap"/>
65 | It is my hope that this way of displaying annotations will catch on and eventually become wide spread throughout the pharma industry.
66 | 
67 | This is very much a work in progress, and I plan to make new versions of `crf_1_3_2.xsl` as new versions of ODM are released. XSL file names are planned to follow the ODM version.
68 | 
69 | At the same time I invite others to improve of my XSL programming, make suggestions to annotation conventions, and generally be involved and debate the use of ODM-xml in the way presented here.
70 | 
71 | # License <a name="License"/>
72 | Distributed under the MIT License. See [LICENSE](https://github.com/jmangori/CDISC-ODM-and-Define-XML-tools/blob/master/LICENSE) for more information.
73 | 
74 | # Contact <a name="Contact"/>
75 | Jørgen Mangor Iversen [jmi@try2.info](mailto:jmi@try2.info)
76 | 
77 | [Live version](https://try2.info/cdisc-xml/cdisc-xml.html) to demonstrate the principle.
78 | 
79 | My [LinkedIn](https://www.linkedin.com/in/jørgen-iversen-ab5908b/) profile.
80 | 
81 | # Acknowledgements <a name="Acknowledgements"/>
82 | Thanks to [Martin Honnen](https://github.com/martin-honnen/martin-honnen.github.io/blob/master/xslt/arcor-archive/2016/test2016081501.html) for code to execute asynchronous `XSLTProcessor()` client side in the browser.
83 | 
84 | This software is made public with the explicit permission from LEO Pharma A/S.
85 | 


--------------------------------------------------------------------------------
/CRF_renditions.md:
--------------------------------------------------------------------------------
 1 | #### Table of Contents
 2 | * [CRF Renditions](#CRF_Renditions)
 3 |    * [CRF layout](#CRF_layout)
 4 |    * [Design choices](#Design_choices)
 5 |       * [SDTM Datasets and Variables](#SDTM_Datasets_and_Variables)
 6 |    * [Parameters](#Parameters)
 7 |    * [Creating PDF documents](#Creating_PDF_documents)
 8 | 
 9 | # CRF Renditions <a name="CRF_Renditions"/>
10 | A short description of how the style sheet generates the CRF pages in the browser from the ODM-xml document.
11 | 
12 | ## CRF layout <a name="CRF_layout"/>
13 | The main feature of the CRF layout presented here is to put the SDTM annotations in a column adjacent to each question line. This way the SDTM annotations are displayed at the proper location, without the need to move boxes of annotations around inside and on top of CRF elements. Even if this takes some space from the CRF Forms width, please notice that the [acrf](/examples/acrf.pdf) is a documentation of the SDTM annotations, while the [bcrf](/examples/bcrf.pdf) is the documentation of the CRF pages themselves. This split also allows space for more rich SDTM annotations.
14 | 
15 | ![Example CRF rendition from pure ODM-xml](images/CRF.png)
16 | 
17 | The CRF rendition consists of one table for each Form in the CRF, identified as **FormDef** tags, having the columns below.
18 | 1. A sequence number constructed from the **@OrderNumber** attributes of **ItemGroupRef** and **ItemRef** tags in the ODM-xml file. The number serves as a human reference when discussing and reviewing CRF content, as well as keeping track of the sorting of CRF elements. If a Form or a Question has an implementation note, a hash sign (**#**) is shown next to the number, and the actual note in a footnote after the CRF page, referring to the number
19 | 2. The Question from the CRF Forms identified as **Question/TranslatedText** tags. Any completion instruction in tag **Alias[@Context='completionInstructions']/@Name** is shown with the Question
20 | 3. The answer to the Question distinguished by **@DataType** attributes. Each data type is displayed as a browser specific interpretation of an HTML tag of the corresponding type. As no indication of multiple selects exist in the ODM definition, this data type is extracted from the text itself, triggered by the string **all that apply** within the tags
21 |    * ItemDef/@Name
22 |    * ItemDef/Question/TranslatedText
23 |    * ItemDef/Description/TranslatedText
24 |    * ItemDef/Alias[@Context='completionInstructions']/@Name
25 | 4. The SDTM annotation identified as **@SDSVarName** attributes. Additional information is added from **Alias/@Name** attributes having a **@Context='SDTM'** attribute as SDTM annotation marker. Each sentence separated by `'. '` (period blank) in the SDTM annotation is presented on a line of its own for readability. SDTM dataset names are extracted from either **ItemGroupDef/@Domain** or **ItemDef/@SDSVarName** attributes, where the latter may be a two-level name separated by a period `dataset.variable`
26 | 
27 | ## Design choices <a name="Design_choices"/>
28 | All vendor specific name spaces and XML addendums to the ODM-XML file are ignored.
29 | 
30 | The following assumptions regarding the specifics of the ODM-XML files XPATH are used:
31 | CRF Element             | XPath                                                          | Comment
32 | ---                     | ---                                                            | ---
33 | Form Title/Name         | FormDef/Description/TranslatedText                             | As it appears on the CRF
34 | Section Title/Name      | Sections/ItemGroup/@Name                                       | Never displayed
35 | Question Text           | ItemDef/Question/TranslatedText                                | As it appears on the CRF
36 | Prompt                  | ItemDef/Alias[@Context="prompt"]/@Name                         | If present in ODM-XML
37 | Completion Instructions | ItemDef/Alias[@Context="completionInstructions"]/@Name         | If present in ODM-XML
38 | Implementation Notes    | ItemDef/Alias[@Context="implementationNotes"]/@Name            | If present in ODM-XML
39 | Mapping Instructions    | ItemDef/Alias[@Context='mappingInstructions']/@Name            | If present in ODM-XML
40 | CDASH                   | ItemDef/Alias[@Context="CDASH"]/@Name                          | Optional, controlled by a parameter
41 | SDTM                    | ItemDef/@SDSVarName <br/> ItemDef/Alias[@Context="SDTM"]/@Name | When @Domain attribute not present, Dataset.Variable syntax is assumed
42 | 
43 | Great inspiration, as well as the CRF contents, is taken from the [eCRF portal on the CDISC website](https://www.cdisc.org/kb/ecrf). I have made very few changes of my own to the CRF contents to adapt it to my solution. These do include a cleanup of the SDTM annotations and choices, such as:
44 | * All text constants are enclosed in quotation marks
45 | * Consistent use of single quotation marks in the SDTM annotations
46 | * Addition of a reference number for each CRF Question. This has proved useful when reviewing CRFs
47 | * Instructions/notes are written using a smaller font and in _italics_
48 | 
49 | ### SDTM Datasets and Variables <a name="SDTM_Datasets_and_Variables"/>
50 | Some debate has been encountered on how to capture Dataset name and Variable name for SDTM annotations in ODM-XML. Some ODM editing/generating systems use the **ItemGroupDef/@Domain** attribute to hold the Dataset name, some do not. Most seems to agree on **ItemDef/@SDSVarName** for the SDTM Variable name. I have chosen to support both, selecting **ItemGroupDef/@Domain** when present, but really encouraging using 2-level names in **ItemDef/@SDSVarName**.
51 | 
52 | The main reason for this is to remove the binding between CRF layout and SDTM annotations, imposed by having the Dataset name in the **@Domain** attribute on **@ItemGroupDef** level, and the Variable name in the **SDSVarName** attribute on **ItemDef** level. While this may seem logical by mimicking the tabular Dataset/Variable structure, it really serves no purpose beyond dictating that CRF Forms must be designed following SDTM dataset structure. Practical experience has shown that complex Forms (e.g. Adverse events) often annotate to different SDTM domains (e.g. AE and SUPPAE) in an alternating way, and thus dictates the change of **@ItemGroupDef** (sections) to change domain, serving only SDTM annotation purposes.
53 | 
54 | My [interim] solution is to have **SDSVarName** contain both Dataset name and Variable name separated by a period (e.g. AE.AETERM) in common SQL style. A better and more permanent solution is to advocate that [CDISC](https://www.cdisc.org/) moves the **@Domain** attribute to the **ItemDef** level i their ODM-XML specification. This will ensure that the Dataset name is specified at the same level as the Variable name, eliminating the need for the CRF sections to be structured after the SDTM annotations. Although this will call for redundant specification of Dataset names in an ODM file, ODM editing/generating systems ought to be able to populate this from SDTM specifications.
55 | 
56 | ## Parameters <a name="Parameters"/>
57 | Parameters to the `crf_1_3_2.xsl` file are documented in the table below
58 | 
59 | Parameter | Description | Default value | Comment
60 | ---         | ---                                 | ---                        | ---
61 | parmdisplay | Display mode                        | spec                       | **spec**: CRF specification with implementation notes, SDTM annotations, etc. <br/> **bcrf**: Blank CRF for submission <br/> **acrf**: SDTM annotated CRF for submission <br/> **book**: Complete CRF book with forms repeated by visit
62 | parmstudy   | Name of study or standard           |                            | Can be derived from ODM file name
63 | parmversion | Version of the ODM-XML file         |                            | Can be derived from ODM file name
64 | parmstatus  | Status of the ODM-XML file          |                            | Can be derived from ODM file name
65 | parmname    | Company name                        | My Company                 | User supplied
66 | parmlogo    | Company logo file name              |                            | User supplied
67 | parmlang    | Language of TranslatedText          | All, assuming one language | Future implementation
68 | parmcdash   | Display CDASH annotation from Alias | 1                          | If present, 0 or 1
69 | 
70 | ## Creating PDF documents <a name="Creating_PDF_documents"/>
71 | In all browsers, print the CRF renditions as PDF documents on your disk as either SDTM annotated CRF specification,  complete CRF book, [acrf](/examples/acrf.pdf) or [bcrf](/examples/bcrf.pdf) submission documents, respectively. Please note:
72 | * The on-screen button is not included in PDF documents created by printing to a PDF file
73 | * The TOC will work correctly as links within the PDF documents
74 | * Form names in the visit matrix works (when present) as links as well, in addition to the TOC
75 | * All space delimited words in the SDTM annotations have link targets, reachable from **define-xml**, provided that CRF origins in **define.xml** are created as named destinations to SDTM variables, and not as page numbers
76 | * The yellow background color of the SDTM annotations requires printing of background graphics to be part of PDF documents
77 | * Headers and footers, portrait versus landscape, and other document properties can be controlled within the printing dialog of your browser
78 | * Different browsers may behave slightly different
79 | 


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/files/cdisc-xml.html:
--------------------------------------------------------------------------------
  1 | <!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Strict//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-strict.dtd">
  2 | <!--
  3 |   Copyright (c) 2022 Jørgen Mangor Iversen
  4 | 
  5 |   Permission is hereby granted, free of charge, to any person obtaining a copy
  6 |   of this software and associated documentation files (the "Software"), to deal
  7 |   in the Software without restriction, including without limitation the rights
  8 |   to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
  9 |   copies of the Software, and to permit persons to whom the Software is
 10 |   furnished to do so, subject to the following conditions:
 11 | 
 12 |   The above copyright notice and this permission notice shall be included in all
 13 |   copies or substantial portions of the Software.
 14 | 
 15 |   THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
 16 |   IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
 17 |   FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
 18 |   AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
 19 |   LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
 20 |   OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
 21 |   SOFTWARE.
 22 | -->
 23 | <html>
 24 |   <head>
 25 |     <meta http-equiv="Content-Type" content="text/html; charset=utf-8">
 26 |     <title>CDISC XML</title>
 27 |     <meta http-equiv="X-UA-Compatible" content="IE=9">
 28 |     <meta http-equiv="Cache-Control" content="no-cache, no-store, must-revalidate">
 29 |     <meta http-equiv="Pragma" content="no-cache">
 30 |     <meta http-equiv="Expires" content="0">
 31 |     <meta name="Author" content="Jørgen Mangor Iversen">
 32 |     <style>
 33 |       *            { font-family: Helvetica, Arial, sans-serif !important; line-height: 1.3em; margin-bottom: 0.2em; }
 34 |       h1, ul       { margin-top: 0; margin-bottom: 0; }
 35 |       h2, h3       { margin-top: 0.2em; margin-botton: 0.2em; }
 36 |       .narrow      { margin-left: 20%; margin-right: 20%; }
 37 |       .column      { float: left; }
 38 |       .left        { width: 35%; }
 39 |       .center      { width: 35%; }
 40 |       .right       { width: 30%; }
 41 |       .centright   { width: 65%; }
 42 |       .row:after   { content: ""; display: table; clear: both; }
 43 |       .greyed      { color: Grey; }
 44 |       .defineparms  { color: LightGrey; }
 45 |       .indent      { list-style-type: none; padding-left: 1.4em; }
 46 |     </style>
 47 |     <script>
 48 |       function valform() {
 49 |         if (document.getElementById("parmxml").value == '') {
 50 |           alert("You must specify an XML file name");
 51 |           return false;
 52 |         }
 53 |         if (document.getElementById("parmxsl").value == '') {
 54 |           alert("You must specify an XSL file name");
 55 |           return false;
 56 |         }
 57 |         var number = document.getElementById("ncli").value;
 58 |         if (isNaN(number) || number < 0 || number > 999) {
 59 |           alert("Number of CodeListItems must be numeric in the interval 0-999");
 60 |           return false;
 61 |         }
 62 |       }
 63 | 
 64 |       function displayxml() {
 65 |         var parmxml  = document.getElementById("parmxml").value;
 66 |         if (parmxml.match(/ Version /i) && parmxml.match(/ CRF /i)) {
 67 |           var parts = parmxml.split(" ");
 68 |           for (var versix = 0; parts[versix].toLowerCase() != "version"; versix++);
 69 |           var version = parts[versix] + " " + parts[versix + 1];
 70 |           var study   = parmxml.substring(parmxml.lastIndexOf("\\") + 1, parmxml.toUpperCase().indexOf(" CRF "));  // Remove C:\fakepath\
 71 |           var status  = parts[versix + 2].split(".")[0];
 72 |           for (var statix = versix + 3; statix < parts.length; statix++)
 73 |             status = status + " " + parts[statix].split(".")[0];
 74 |           document.getElementById("parmstudy"             ).value = study;
 75 |           document.getElementById("parmstatus"            ).value = status;
 76 |           document.getElementById("parmversion"           ).value = version;
 77 |           document.getElementById("parmcdash"             ).value = document.getElementById("cdash").checked ? "1" : "0";
 78 |           document.getElementById("parmoids"              ).value = document.getElementById("oids").checked  ? "1" : "0";
 79 |           document.getElementById("parmlang"              ).value = document.getElementById("lang").value;
 80 |           document.getElementById("nCodeListItemDisplay"  ).value = document.getElementById("ncli").value;
 81 |           document.getElementById("displayMethodsTable"   ).value = document.getElementById("methods").value;
 82 |           document.getElementById("displayCommentsTable"  ).value = document.getElementById("comments").value;
 83 |           document.getElementById("displayPrefix"          ).value = document.getElementById("prefix").value;
 84 |           document.getElementById("displayLengthDFormatSD").value = document.getElementById("lenform").value;
 85 |         }
 86 |       }
 87 | 
 88 |       function toggleXls() {
 89 |         var selected = document.getElementById("parmxsl").value.toLowerCase();
 90 |         selected = selected.substring(selected.lastIndexOf("\\") + 1); // Remove C:\fakepath\
 91 |         if (selected.startsWith("define"))
 92 |           for (element of document.getElementsByClassName("crfparms")) {
 93 |             element.style.color = "LightGrey";
 94 |             element.disabled = true;
 95 |           }
 96 |         else
 97 |           for (element of document.getElementsByClassName("crfparms")) {
 98 |             element.style.color = "black";
 99 |             element.disabled = false;
100 |           }
101 |         if (selected.startsWith("define2"))
102 |           for (element of document.getElementsByClassName("defineparms")) {
103 |             element.style.color = "black";
104 |             element.disabled = false;
105 |           }
106 |         else
107 |           for (element of document.getElementsByClassName("defineparms")) {
108 |             element.style.color = "LightGrey";
109 |             element.disabled = true;
110 |           }
111 |       }
112 | 
113 |       function toggleCheck() {
114 |         if (document.getElementById("spec").checked) {
115 |           document.getElementById("cdash").disabled = false;
116 |         }
117 |         if (document.getElementById("acrf").checked) {
118 |           document.getElementById("cdash").disabled = true;
119 |           document.getElementById("cdash").checked  = false;
120 |         }
121 |         if (document.getElementById("bcrf").checked) {
122 |           document.getElementById("cdash").checked  = false;
123 |           document.getElementById("cdash").disabled = true;
124 |         }
125 |         if (document.getElementById("book").checked) {
126 |           document.getElementById("cdash").disabled = true;
127 |           document.getElementById("cdash").checked  = false;
128 |         }
129 |       }
130 |     </script>
131 |   </head>
132 |   <body class="narrow" onLoad="document.getElementById('parmxsl').addEventListener('input', toggleXls);">
133 |     <form name="parms" action="cdisc-xml.php" onSubmit="return valform()" method="post" enctype="multipart/form-data">
134 |       <input type="hidden" name="parmstudy"              id="parmstudy"/>
135 |       <input type="hidden" name="parmstatus"             id="parmstatus"n/>
136 |       <input type="hidden" name="parmversion"            id="parmversion"/>
137 |       <input type="hidden" name="parmcdash"              id="parmcdash"/>
138 |       <input type="hidden" name="parmoids"               id="parmoids"/>
139 |       <input type="hidden" name="parmlang"               id="parmlang"/>
140 |       <input type="hidden" name="nCodeListItemDisplay"   id="nCodeListItemDisplay"/>
141 |       <input type="hidden" name="displayMethodsTable"    id="displayMethodsTable"/>
142 |       <input type="hidden" name="displayCommentsTable"   id="displayCommentsTable"/>
143 |       <input type="hidden" name="displayPrefix"           id="displayPrefix"/>
144 |       <input type="hidden" name="displayLengthDFormatSD" id="displayLengthDFormatSD"/>
145 |       <h1>Display ODM-xml or Define-xml files in the browser</h1>
146 |       <h2>Usage</h2>
147 |       Chose a valid XML document and display it in the brower using the appropriate style sheet.
148 |       Style sheet must exist in the same folder as the XML file.
149 |       <br/>
150 |       Please allow up to 20 seconds for a large XML file to render.
151 |       <br/>
152 |       <div class="crfparms">
153 |         Add an optional company name and an optional image file of the company logo to be part of the generated CRF pages.
154 |       </div>
155 | 
156 |       <div class="row">
157 |         <div class="column left">
158 |           &nbsp;
159 |         </div>
160 |         <div class="column center">
161 |           <h3>Selection</h3>
162 |         </div>
163 |         <div class="column left">
164 |           XML file
165 |         </div>
166 |         <div class="column center">
167 |           <input type="file" name="parmxml" id="parmxml" accept="text/xml, .xml" autofocus/>
168 |         </div>
169 |         <div class="column left greyed">
170 |           Naming template
171 |         </div>
172 |         <div class="column centright greyed">
173 |           &lt;Asset name&gt; [CRF|SDTM|ADaM] Version &lt;version number&gt; &lt;status&gt;.xml
174 |         </div>
175 |         <div class="column left">
176 |           XSL Style Sheet
177 |         </div>
178 |         <div class="column center">
179 |           <input type="file" name="parmxsl" id="parmxsl"/>
180 |         </div>
181 | 
182 |         <div class="column left crfparms">
183 |           &nbsp;
184 |         </div>
185 |         <div class="column center crfparms">
186 |           <h3>Parameters for the CRF</h3>
187 |         </div>
188 |         <div class="column left crfparms">
189 |           ODM-XML display type
190 |         </div>
191 |         <div class="column center crfparms">
192 |           <input type="radio" id="spec" name="parmdisplay" class="radio crfparms" value="spec" checked="checked" onClick="toggleCheck();"/>
193 |           <label for="spec">SDTM annotated CRF specification</label>
194 |         </div>
195 |         <div class="column right crfparms">
196 |           <input type="checkbox" name="cdash" id="cdash" class="crfparms"/>
197 |           <label for="cdash">Display CDASH annotations</label>
198 |         </div>
199 |         <div class="column left crfparms">
200 |           &nbsp;
201 |         </div>
202 |         <div class="column center crfparms">
203 |           <input type="radio" id="acrf" name="parmdisplay" class="radio crfparms" value="acrf" onClick="toggleCheck();"/>
204 |           <label for="acrf">SDTM annotated CRF (acrf)</label>
205 |         </div>
206 |         <div class="column left crfparms">
207 |           &nbsp;
208 |         </div>
209 |         <div class="column center crfparms">
210 |           <input type="radio" id="bcrf" name="parmdisplay" class="radio crfparms" value="bcrf" onClick="toggleCheck();"/>
211 |           <label for="bcrf">Blank CRF (bcrf)</label>
212 |         </div>
213 |         <div class="column left crfparms">
214 |           &nbsp;
215 |         </div>
216 |         <div class="column center crfparms">
217 |           <input type="radio" id="book" name="parmdisplay" class="radio crfparms" value="book" onClick="toggleCheck();"/>
218 |           <label for="book">CRF book (forms per visit)</label>
219 |         </div>
220 |         <div class="column left crfparms">
221 |           &nbsp;
222 |         </div>
223 |         <div class="column center crfparms">
224 |           <input type="checkbox" id="oids" name="oids" class="crfparms"/>
225 |           <label for="oids">Display identifiers (OIDs)</label>
226 |         </div>
227 |         <div class="column right crfparms">
228 |           &nbsp;
229 |         </div>
230 |         <div class="column left crfparms">
231 |           Company Name
232 |         </div>
233 |         <div class="column center crfparms">
234 |           <input type="text" name="parmname" id="parmname" class="crfparms" size="30"/>
235 |         </div>
236 |         <div class="column left crfparms">
237 |           Company Logo (image file)
238 |         </div>
239 |         <div class="column center crfparms">
240 |           <input type="file" name="parmlogo" name="parmlogo" id="parmlogo" accept="image/png, .png, image/gif, .gif, image/jpg .jpg, image/jpeg, .jpeg" class="crfparms"/>
241 |         </div>
242 |         <div class="column left crfparms" hidden>
243 |           Language for TranslatedText
244 |         </div>
245 |         <div class="column center crfparms" hidden>
246 |           <input type="text" name="lang" id="lang" size="5" class="crfparms" disabled="true"/> (I.e. blank, FR, fr-CA)
247 |         </div>
248 | 
249 |         <div class="column left defineparms">
250 |           &nbsp;
251 |         </div>
252 |         <div class="column center defineparms">
253 |           <h3>Parameters for Define-xml v 2</h3>
254 |         </div>
255 |         <div class="column left defineparms">
256 |           Number of CodeListItems to display
257 |         </div>
258 |         <div class="column center defineparms">
259 |           <input type="number" name="ncli" id="ncli" min="0" max="999" step="1" value="5" disabled="true" class="defineparms"/>
260 |           <label for="ncli">0 = No CodeListItems, 999 = All CodeListItems.</label>
261 |         </div>
262 |         <div class="column left defineparms">
263 |           Display Methods table
264 |         </div>
265 |         <div class="column center defineparms">
266 |           <input type="checkbox" name="methods" id="methods" checked disabled="true" class="defineparms"/>
267 |         </div>
268 |         <div class="column left defineparms">
269 |           Display Comments table
270 |         </div>
271 |         <div class="column center defineparms">
272 |           <input type="checkbox" name="comments" id="comments" disabled="true" class="defineparms"/>
273 |         </div>
274 |         <div class="column left defineparms">
275 |           Display Prefixes ([Comment], [Method], [Origin])
276 |         </div>
277 |         <div class="column center defineparms">
278 |           <input type="checkbox" name="prefix" id="prefix" disabled="true" class="defineparms"/>
279 |         </div>
280 |         <div class="column left defineparms">
281 |           Display Length, DisplayFormat and Significant Digits
282 |         </div>
283 |         <div class="column center defineparms">
284 |           <input type="checkbox" name="lenform" id="lenform" disabled="true" class="defineparms"/>
285 |         </div>
286 | 
287 |         <div class="column left">
288 |           &nbsp;
289 |         </div>
290 |         <div class="column center">
291 |           <h3>Display</h3>
292 |         </div>
293 |         <div class="column left">
294 |           &nbsp;
295 |         </div>
296 |         <div class="column center">
297 |           <input type="submit" onclick="displayxml();" value="Display XML file with XSL Style Sheet"/>
298 |         </div>
299 |       </div>
300 | 
301 |       <h2>Creating PDF documents</h2>
302 |       In all browsers, print the HTML renditions as PDF documents to disk as either SDTM annotated CRF specification, define.pdf, acrf.pdf or bcrf.pdf submission documents, etc.
303 |       <br/>
304 |       Please note:
305 |       <ul>
306 |         <li>Headers and footers, portrait versus landscape, and other document properties can be controlled within the printing dialog of your browser.</li>
307 |         <li>Background color(s) requires printing of background graphics to be part of PDF documents.</li>
308 |         <li>The on-screen buttons of the HTML rendition are not included in PDF documents created by printing to a PDF file.</li>
309 |         <li class="crfparms">The TOC/visit matrix will work correctly as navigation links within the PDF documents.</li>
310 |         <li class="crfparms">All SDTM annotations on SDTM annotated CRF documents have link targets available from define-xml, when <strong>Orgin</strong> is set to SDTM variable name as Named Destination.</li>
311 |       </ul>
312 |     </form>
313 |   </body>
314 | </html>
315 | 


--------------------------------------------------------------------------------
/files/cdisc xml.html:
--------------------------------------------------------------------------------
  1 | <!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Strict//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-strict.dtd">
  2 | <!--
  3 |   Copyright (c) 2021 Jørgen Mangor Iversen
  4 | 
  5 |   Permission is hereby granted, free of charge, to any person obtaining a copy
  6 |   of this software and associated documentation files (the "Software"), to deal
  7 |   in the Software without restriction, including without limitation the rights
  8 |   to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
  9 |   copies of the Software, and to permit persons to whom the Software is
 10 |   furnished to do so, subject to the following conditions:
 11 | 
 12 |   The above copyright notice and this permission notice shall be included in all
 13 |   copies or substantial portions of the Software.
 14 | 
 15 |   THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
 16 |   IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
 17 |   FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
 18 |   AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
 19 |   LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
 20 |   OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
 21 |   SOFTWARE.
 22 | -->
 23 | <html>
 24 |   <head>
 25 |     <meta http-equiv="Content-Type" content="text/html; charset=utf-8">
 26 |     <title>CDISC XML</title>
 27 |     <meta http-equiv="X-UA-Compatible" content="IE=9">
 28 |     <meta http-equiv="cache-control" content="no-cache">
 29 |     <meta http-equiv="pragma" content="no-cache">
 30 |     <meta http-equiv="expires" content="0">
 31 |     <meta name="Author" content="Jørgen Mangor Iversen">
 32 |     <style>
 33 |       *            { font-family: Helvetica, Arial, sans-serif !important; line-height: 1.3em; margin-bottom: 0.2em; }
 34 |       h1, ul       { margin-top: 0; margin-bottom: 0; }
 35 |       h2, h3       { margin-top: 0.2em; margin-botton: 0.2em; }
 36 |       fieldset     { margin: 0; padding: 0; border: 0; }
 37 |       .narrow      { margin-left: 20%; margin-right: 20%; }
 38 |       .column      { float: left; }
 39 |       .left        { width: 35%; }
 40 |       .right       { width: 65%; }
 41 |       .row:after   { content: ""; display: table; clear: both; }
 42 |       .greyed      { color: Grey; }
 43 |       .defineparms { color: LightGrey; }
 44 |       .indent      { list-style-type: none; padding-left: 1.4em; }
 45 |     </style>
 46 |     <script>
 47 |       const urlParams   = new URLSearchParams(window.location.search);
 48 |       const workspaceId = urlParams.get('workspaceId');
 49 | 
 50 |       function loadDoc(url) {
 51 |         return new Promise(function(resolve) {
 52 |           var req = new XMLHttpRequest();
 53 |           req.open("GET", url.concat('?workspaceId=', workspaceId));
 54 |           req.onload = function() {
 55 |             resolve(this.responseXML)
 56 |           }
 57 |           req.send();
 58 |         });
 59 |       }
 60 | 
 61 |       function transform(xmlUrl, xslUrl, display, name, logo, study, version, status, language, cdash, ncli, method, comment, prefix, lenformd, targetElement) {
 62 |         targetElement.innerHTML = '<canvas id="canvas" width="100" height="100" style="background-color:#fff; position: fixed;top: 50%;left: 50%;transform: translate(-50%, -50%);"/>';
 63 |         var canvas = document.getElementById("canvas");
 64 |         var ctx = canvas.getContext("2d");
 65 |         var radius = canvas.height / 2;
 66 |         ctx.translate(radius, radius);
 67 |         radius = radius * 0.90
 68 |         setInterval(drawClock, 1000);
 69 | 
 70 |         function drawClock() {
 71 |           drawFace(ctx, radius);
 72 |           drawNumbers(ctx, radius);
 73 |           drawTime(ctx, radius);
 74 |         }
 75 | 
 76 |         function drawFace(ctx, radius) {
 77 |           var grad;
 78 |           ctx.beginPath();
 79 |           ctx.arc(0, 0, radius, 0, 2*Math.PI);
 80 |           ctx.fillStyle = 'white';
 81 |           ctx.fill();
 82 |           grad = ctx.createRadialGradient(0,0,radius*0.95, 0,0,radius*1.05);
 83 |           grad.addColorStop(0, '#333');
 84 |           grad.addColorStop(0.5, 'white');
 85 |           grad.addColorStop(1, '#333');
 86 |           ctx.strokeStyle = grad;
 87 |           ctx.lineWidth = radius*0.1;
 88 |           ctx.stroke();
 89 |           ctx.beginPath();
 90 |           ctx.arc(0, 0, radius*0.1, 0, 2*Math.PI);
 91 |           ctx.fillStyle = '#333';
 92 |           ctx.fill();
 93 |         }
 94 | 
 95 |         function drawNumbers(ctx, radius) {
 96 |           var ang;
 97 |           var num;
 98 |           ctx.font = radius*0.15 + "px arial";
 99 |           ctx.textBaseline="middle";
100 |           ctx.textAlign="center";
101 |           for(num = 1; num < 13; num++){
102 |             ang = num * Math.PI / 6;
103 |             ctx.rotate(ang);
104 |             ctx.translate(0, -radius*0.85);
105 |             ctx.rotate(-ang);
106 |             ctx.fillText(num.toString(), 0, 0);
107 |             ctx.rotate(ang);
108 |             ctx.translate(0, radius*0.85);
109 |             ctx.rotate(-ang);
110 |           }
111 |         }
112 | 
113 |         function drawTime(ctx, radius){
114 |             var now = new Date();
115 |             var hour = now.getHours();
116 |             var minute = now.getMinutes();
117 |             var second = now.getSeconds();
118 |             //hour
119 |             hour=hour%12;
120 |             hour=(hour*Math.PI/6)+
121 |             (minute*Math.PI/(6*60))+
122 |             (second*Math.PI/(360*60));
123 |             drawHand(ctx, hour, radius*0.5, radius*0.07);
124 |             //minute
125 |             minute=(minute*Math.PI/30)+(second*Math.PI/(30*60));
126 |             drawHand(ctx, minute, radius*0.8, radius*0.07);
127 |             // second
128 |             second=(second*Math.PI/30);
129 |             drawHand(ctx, second, radius*0.9, radius*0.02);
130 |         }
131 | 
132 |         function drawHand(ctx, pos, length, width) {
133 |             ctx.beginPath();
134 |             ctx.lineWidth = width;
135 |             ctx.lineCap = "round";
136 |             ctx.moveTo(0,0);
137 |             ctx.rotate(pos);
138 |             ctx.lineTo(0, -length);
139 |             ctx.stroke();
140 |             ctx.rotate(-pos);
141 |         }
142 | 
143 |         Promise.all([loadDoc(xmlUrl), loadDoc(xslUrl)]).then(function(data) {
144 |           var xmlDoc = data[0];
145 |           var xslDoc = data[1];
146 |           var proc = new XSLTProcessor();
147 |           proc.importStylesheet(xslDoc);
148 |           if (display  !== undefined) proc.setParameter(null, "parmdisplay",            display);
149 |           if (name     !== undefined) proc.setParameter(null, "parmname",               name);
150 |           if (logo     !== undefined) proc.setParameter(null, "parmlogo",               logo);
151 |           if (study    !== undefined) proc.setParameter(null, "parmstudy",              study);
152 |           if (version  !== undefined) proc.setParameter(null, "parmversion",            version);
153 |           if (status   !== undefined) proc.setParameter(null, "parmstatus",             status);
154 |           if (language !== undefined) proc.setParameter(null, "parmlang",               language);
155 |           if (cdash    !== undefined) proc.setParameter(null, "parmcdash",              cdash);
156 |           if (ncli     !== undefined) proc.setParameter(null, "nCodeListItemDisplay",   ncli);
157 |           if (method   !== undefined) proc.setParameter(null, "displayMethodsTable",    method);
158 |           if (comment  !== undefined) proc.setParameter(null, "displayCommentsTable",   comment);
159 |           if (prefix   !== undefined) proc.setParameter(null, "displayPrefix",          prefix);
160 |           if (lenformd !== undefined) proc.setParameter(null, "displayLengthDFormatSD", lenformd);
161 | 
162 |           var resultFrag = proc.transformToFragment(xmlDoc, targetElement.ownerDocument);
163 | 
164 |           targetElement.textContent = '';
165 |           targetElement.appendChild(resultFrag);
166 |         }).catch(error => { console.log(`Error in promises ${error}`);
167 |            targetElement.innerHTML =
168 |             '<h1 style="text-align:center;">Error in the rendition</h1>' +
169 |             '<h2 style="text-align:center;">Page parameters</h2>' +
170 |             '<table style="margin-left: auto; margin-right: auto;">' +
171 |             '<tr><td>XML File            </td><td>' + xmlUrl   + '</td></tr>' +
172 |             '<tr><td>Style Sheet         </td><td>' + xslUrl   + '</td></tr>' +
173 |             '<tr><td>Display option      </td><td>' + display  + '</td></tr>' +
174 |             '<tr><td>CDASH               </td><td>' + cdash    + '</td></tr>' +
175 |             '<tr><td>Company name        </td><td>' + name     + '</td></tr>' +
176 |             '<tr><td>Logo                </td><td>' + logo     + '</td></tr>' +
177 |             '<tr><td>Study               </td><td>' + study    + '</td></tr>' +
178 |             '<tr><td>Version             </td><td>' + version  + '</td></tr>' +
179 |             '<tr><td>Status              </td><td>' + status   + '</td></tr>' +
180 |             '<tr><td>Language            </td><td>' + language + '</td></tr>' +
181 |             '<tr><td>CodeListItem number </td><td>' + ncli     + '</td></tr>' +
182 |             '<tr><td>Display Methods     </td><td>' + method   + '</td></tr>' +
183 |             '<tr><td>Display Comments    </td><td>' + comment  + '</td></tr>' +
184 |             '<tr><td>Display Prefix      </td><td>' + prefix   + '</td></tr>' +
185 |             '<tr><td>Length Format Digits</td><td>' + lenformd + '</td></tr>' +
186 |             '</table>' +
187 |             '<h2 style="text-align:center;">System messages</h2>' +
188 |             '<p  style="text-align:center;">' + error + '</p>' +
189 |             '<p style="text-align:center;"><button onClick="window.location.reload();">Refresh Page</button></p>'
190 |            });
191 |       }
192 | 
193 |       function displayxml() {
194 |         if (document.getElementById("parmxml").value == '') {
195 |           alert("You must specify an XML file name");
196 |           return false;
197 |         }
198 |         var number = document.getElementById("nCodeListItemDisplay").value;
199 |         if (isNaN(number) || number < 0 || number > 999) {
200 |           alert("Number of CodeListItems must be numeric in the interval 0-999");
201 |           return false;
202 |         }
203 | 
204 |         for (var button of document.getElementsByClassName("radio"))
205 |           if (button.checked)
206 |             var display = button.value;
207 |         var name     = document.getElementById("parmname").value;
208 |         var logo     = document.getElementById("parmlogo").value;
209 |         var parmxml  = document.getElementById("parmxml").value;
210 |         var parmxsl  = document.getElementById("parmxsl").value;
211 |         var language = document.getElementById("parmlang").value;
212 |         var cdash    = document.getElementById("parmcdash").checked              ? "1" : "0";
213 |         var ncli     = document.getElementById("nCodeListItemDisplay").value;
214 |         var method   = document.getElementById("displayMethodsTable").checked    ? "1" : "0";
215 |         var comment  = document.getElementById("displayCommentsTable").checked   ? "1" : "0";
216 |         var prefix   = document.getElementById("displayPrefix").checked          ? "1" : "0";
217 |         var lenformd = document.getElementById("displayLengthDFormatSD").checked ? "1" : "0";
218 |         if (parmxml.match(/ Version /i) && parmxml.match(/ CRF /i)) {
219 |           var parts = parmxml.split(" ");
220 |           for (var versix = 0; parts[versix].toLowerCase() != "version"; versix++);
221 |           var version = parts[versix] + " " + parts[versix + 1];
222 |           var study   = parmxml.substring(0, parmxml.toUpperCase().indexOf(" CRF "));
223 |           var status  = parts[versix + 2].split(".")[0];
224 |           for (var statix = versix + 3; statix < parts.length; statix++)
225 |             status = status + " " + parts[statix].split(".")[0];
226 |         }
227 |         transform(parmxml, parmxsl, display, name, logo, study, version, status, language, cdash, ncli, method, comment, prefix, lenformd, document.documentElement);
228 |       }
229 | 
230 |       function toggle() {
231 |         var selected = document.getElementById("parmxsl").value.toLowerCase();
232 |         if (selected.startsWith("define"))
233 |           for (element of document.getElementsByClassName("crfparms")) {
234 |             element.style.color = "LightGrey";
235 |             element.disabled = true;
236 |           }
237 |         else
238 |           for (element of document.getElementsByClassName("crfparms")) {
239 |             element.style.color = "black";
240 |             element.disabled = false;
241 |           }
242 |         if (selected.startsWith("define2-1"))
243 |           for (element of document.getElementsByClassName("defineparms")) {
244 |             element.style.color = "black";
245 |             element.disabled = false;
246 |           }
247 |         else
248 |           for (element of document.getElementsByClassName("defineparms")) {
249 |             element.style.color = "LightGrey";
250 |             element.disabled = true;
251 |           }
252 |       }
253 |     </script>
254 |   </head>
255 |   <body class="narrow" onLoad="document.getElementById('parmxsl').value = document.getElementById('serverxsl').value;document.getElementById('parmlogo').value = document.getElementById('serverlogo').value;">
256 |     <form>
257 |       <h1>Display ODM-xml or Define-xml files in the browser</h1>
258 |       <h2>Usage</h2>
259 |       Chose a valid XML document and display it in the brower using the appropriate style sheet.
260 |       Style sheet must exist in the same folder as the XML file.
261 |       <div/>
262 |       Please allow up to 20 seconds for a large XML file to render.
263 |       <div/>
264 |       <div class="crfparms">
265 |         Add an optional company name and an optional image file of the company logo to be part of the generated CRF pages.
266 |       </div>
267 | 
268 |       <div class="row">
269 |         <div class="column left">
270 |           &nbsp;
271 |         </div>
272 |         <div class="column right">
273 |           <h3>Selection</h3>
274 |         </div>
275 |         <div class="column left">
276 |           XML file
277 |         </div>
278 |         <div class="column right">
279 |           <input type="text" id="parmxml" size="35" accept=".xml" placeholder="1401 CRF Version 7 Draft.xml" autofocus/>
280 |         </div>
281 |         <div class="column left greyed">
282 |           Naming template
283 |         </div>
284 |         <div class="column right greyed">
285 |           &lt;Asset name&gt; [CRF|SDTM|ADaM] Version &lt;version number&gt; &lt;status&gt;.xml
286 |         </div>
287 |         <div class="column left">
288 |           XSL Style Sheet
289 |         </div>
290 |         <div class="column right">
291 |           <select id="parmxsl" onchange="toggle();">
292 |             <option value="crf_1_3_2.xsl" selected       >ODM-XML v 1.3.2       </option>
293 |             <option value="crf_2_0.xsl" disabled="true"  >ODM-XML v 2.0 (future)</option>
294 |             <option value="define2-0-0.xsl"              >Define-xml v 2.0      </option>
295 |             <option value="define2-1.xsl" disabled="true">Define-xml v 2.1      </option>
296 |           </select>
297 |         </div>
298 | 
299 |         <fieldset>
300 |           <div class="column left crfparms">
301 |             &nbsp;
302 |           </div>
303 |           <div class="column right crfparms">
304 |             <h3>Parameters for the CRF</h3>
305 |           </div>
306 |           <div class="column left crfparms">
307 |             ODM-XML display type
308 |           </div>
309 |           <div class="column right crfparms">
310 |             <input type="radio" id="spec" name="display" class="radio crfparms" value="spec" checked="checked"/>
311 |             <label for="spec">SDTM annotated CRF specification</label>
312 |             <ul class="indent">
313 |               <li>
314 |                 <input type="checkbox" id="parmcdash" class="crfparms"/>
315 |                 <label for="parmcdash">Display CDASH annotations</label>
316 |               </li>
317 |             </ul>
318 |             <input type="radio" id="acrf" name="display" class="radio crfparms" value="acrf"/>
319 |             <label for="acrf">SDTM annotated CRF (acrf)</label>
320 |             <br>
321 |             <input type="radio" id="bcrf" name="display" class="radio crfparms" value="bcrf"/>
322 |             <label for="bcrf">Blank CRF (bcrf)</label>
323 |             <br>
324 |             <input type="radio" id="book" name="display" class="radio crfparms" value="book"/>
325 |             <label for="book">CRF book (forms per visit)</label>
326 |           </div>
327 |           <div class="column left crfparms">
328 |             Company Name
329 |           </div>
330 |           <div class="column right crfparms">
331 |             <input type="text" id="parmname" placeholder="Your Company" class="crfparms" size="30"/>
332 |           </div>
333 |           <div class="column left crfparms">
334 |             Company Logo (image file)
335 |           </div>
336 |           <div class="column right crfparms">
337 |             <input type="text" id="parmlogo" size="20" accept=".png, .gif,.jpg, .jpeg" value="logo.png" class="crfparms"/>
338 |           </div>
339 |           <div class="column left crfparms" hidden>
340 |             Language for TranslatedText
341 |           </div>
342 |           <div class="column right crfparms" hidden>
343 |             <input type="text" id="parmlang" size="5" class="crfparms"/> (I.e. blank, FR, fr-CA)
344 |           </div>
345 |         </fieldset>
346 | 
347 |         <fieldset>
348 |           <div class="column left defineparms">
349 |             &nbsp;
350 |           </div>
351 |           <div class="column right defineparms">
352 |             <h3>Parameters for Define-xml v 2.1</h3>
353 |           </div>
354 |           <div class="column left defineparms">
355 |             Number of CodeListItems to display
356 |           </div>
357 |           <div class="column right defineparms">
358 |             <input type="number" id="nCodeListItemDisplay" min="0" max="999" step="1" value="5" disabled="true" class="defineparms"/>
359 |             <label for="nCodeListItemDisplay">0 = No CodeListItems, 999 = All CodeListItems.</label>
360 |           </div>
361 |           <div class="column left defineparms">
362 |             Display Methods table
363 |           </div>
364 |           <div class="column right defineparms">
365 |             <input type="checkbox" id="displayMethodsTable" checked disabled="true" class="defineparms"/>
366 |           </div>
367 |           <div class="column left defineparms">
368 |             Display Comments table
369 |           </div>
370 |           <div class="column right defineparms">
371 |             <input type="checkbox" id="displayCommentsTable" disabled="true" class="defineparms"/>
372 |           </div>
373 |           <div class="column left defineparms">
374 |             Display Prefixes ([Comment], [Method], [Origin])
375 |           </div>
376 |           <div class="column right defineparms">
377 |             <input type="checkbox" id="displayPrefix" disabled="true" class="defineparms"/>
378 |           </div>
379 |           <div class="column left defineparms">
380 |             Display Length, DisplayFormat and Significant Digits
381 |           </div>
382 |           <div class="column right defineparms">
383 |             <input type="checkbox" id="displayLengthDFormatSD" disabled="true" class="defineparms"/>
384 |           </div>
385 |         </fieldset>
386 | 
387 |         <div class="column left">
388 |           &nbsp;
389 |         </div>
390 |         <div class="column right">
391 |           <h3>Display</h3>
392 |         </div>
393 |         <div class="column left">
394 |           &nbsp;
395 |         </div>
396 |         <div class="column right">
397 |           <button type="submit" onclick="displayxml();">Display XML file with XSL Style Sheet</button>
398 |         </div>
399 |       </div>
400 | 
401 |       <h2>Creating PDF documents</h2>
402 |       In all browsers, print the HTML renditions as PDF documents to disk as either SDTM annotated CRF specification, define.pdf, acrf.pdf or bcrf.pdf submission documents, etc.
403 |       <br/>
404 |       Please note:
405 |       <ul>
406 |         <li>Headers and footers, portrait versus landscape, and other document properties can be controlled within the printing dialog of your browser.</li>
407 |         <li>Background color(s) requires printing of background graphics to be part of PDF documents.</li>
408 |         <li>The on-screen buttons of the HTML rendition are not included in PDF documents created by printing to a PDF file.</li>
409 |         <li class="crfparms">The TOC/visit matrix will work correctly as navigation links within the PDF documents.</li>
410 |         <li class="crfparms">All SDTM annotations on SDTM annotated CRF documents have link targets available from define-xml, when <strong>Orgin</strong> is set to SDTM variable name as Named Destination.</li>
411 |       </ul>
412 |     </form>
413 |   </body>
414 | </html>
415 | 


--------------------------------------------------------------------------------
/files/crf_1_3_2.xsl:
--------------------------------------------------------------------------------
   1 | <?xml version="1.0" encoding="UTF-8"?>
   2 | <!--
   3 |   Copyright (c) 2021 Jørgen Mangor Iversen
   4 | 
   5 |   Permission is hereby granted, free of charge, to any person obtaining a copy
   6 |   of this software and associated documentation files (the "Software"), to deal
   7 |   in the Software without restriction, including without limitation the rights
   8 |   to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
   9 |   copies of the Software, and to permit persons to whom the Software is
  10 |   furnished to do so, subject to the following conditions:
  11 | 
  12 |   The above copyright notice and this permission notice shall be included in all
  13 |   copies or substantial portions of the Software.
  14 | 
  15 |   THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
  16 |   IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
  17 |   FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
  18 |   AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
  19 |   LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
  20 |   OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
  21 |   SOFTWARE.
  22 | -->
  23 | <xsl:stylesheet xmlns:xsl="http://www.w3.org/1999/XSL/Transform"
  24 |                 xmlns:odm="http://www.cdisc.org/ns/odm/v1.3"
  25 |                 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
  26 |                 xmlns:def="http://www.cdisc.org/ns/def/v2.0"
  27 |                 xmlns:xlink="http://www.w3.org/1999/xlink"
  28 |                 xmlns:arm="http://www.cdisc.org/ns/arm/v1.0"
  29 |                 version="1.0"
  30 |                 xml:lang="en"
  31 |                 exclude-result-prefixes="def xlink odm xsi arm">
  32 |   <xsl:output   method="html"
  33 |                 indent="yes"
  34 |                 encoding="utf-8"
  35 |                 doctype-system="http://www.w3.org/TR/html4/strict.dtd"
  36 |                 doctype-public="-//W3C//DTD HTML 4.01//EN"
  37 |                 version="4.0"/>
  38 | 
  39 |   <!-- Parameters passed from outside. Default display mode is a blank CRF:
  40 |        * spec: CRF specification with selection buttons, implementation notes, SDTM annotations (default)
  41 |        * bcrf: Blank CRF for submission
  42 |        * acrf: SDTM annotated CRF for submission
  43 |        * book: Complete CRF book with forms repeated by visit
  44 |        Standard name, version, and status are derived from the XML file name externally
  45 |        Any image logo file may be resized to fit the text height of a headline, preserving aspect
  46 |   -->
  47 |   <xsl:param name="parmdisplay" select="spec"/> <!-- Display mode -->
  48 |   <xsl:param name="parmstudy"/>                 <!-- Name of any study or standard defined in the ODM-XML file -->
  49 |   <xsl:param name="parmversion"/>               <!-- Version of the ODM-XML file -->
  50 |   <xsl:param name="parmstatus"/>                <!-- Status of the ODM-XML file -->
  51 |   <xsl:param name="parmname"/>                  <!-- Company name -->
  52 |   <xsl:param name="parmlogo"/>                  <!-- Company logo file name -->
  53 |   <xsl:param name="parmlang"/>                  <!-- Language of TranslatedText (future) -->
  54 |   <xsl:param name="parmcdash" select="1"/>      <!-- Display CDASH annotation from Alias (if present) (0/1) -->
  55 |   <xsl:param name="parmoids"  select="0"/>      <!-- Display identifiers (OIDs)          (if present) (0/1) -->
  56 | 
  57 |   <!-- Keys to sort forms in the order of visit schedule, if present -->
  58 |   <xsl:key name="by_StudyEventRef" match="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:Protocol/odm:StudyEventRef" use="@StudyEventOID"/>
  59 |   <xsl:key name="by_FormRef"       match="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:StudyEventDef/odm:FormRef"  use="@FormOID"/>
  60 | 
  61 |   <!-- Variables for case conversion -->
  62 |   <xsl:variable name="lowercase" select="'abcdefghijklmnopqrstuvwxyz'" />
  63 |   <xsl:variable name="uppercase" select="'ABCDEFGHIJKLMNOPQRSTUVWXYZ'" />
  64 | 
  65 |   <xsl:template match="/">
  66 |     <html>
  67 |       <head>
  68 |         <title>
  69 |           <xsl:call-template name="identifier"/>
  70 |           <xsl:text> </xsl:text>
  71 |           <xsl:value-of select="$parmversion"/>
  72 |           <xsl:text> </xsl:text>
  73 |           <xsl:value-of select="$parmstatus"/>
  74 |         </title>
  75 |         <meta http-equiv="Content-Type"    content="text/html;charset=utf-8"/>
  76 |         <meta http-equiv="X-UA-Compatible" content="IE=9"/>
  77 |         <meta http-equiv="cache-control"   content="no-cache"/>
  78 |         <meta http-equiv="pragma"          content="no-cache"/>
  79 |         <meta http-equiv="expires"         content="0"/>
  80 |         <meta name="Author"                content="Jørgen Mangor Iversen"/>
  81 |         <style>
  82 |           html          { margin: 1em 1em 1em 1em; }
  83 |           *             { font-family: Helvetica, Arial, sans-serif !important; }
  84 |           h1, h2, h3, p { text-align: center; }
  85 |           table         { solid DarkGrey; border-spacing: 0; border-collapse: collapse; page-break-inside: auto; }
  86 |           tr            { page-break-inside:avoid; page-break-after:auto; }
  87 |           th, td        { border: 1px solid DarkGrey; }
  88 |           a:link        { color: black; background-color: transparent; text-decoration: none; }
  89 |           a:visited     { color: black; background-color: transparent; text-decoration: none; }
  90 |           a:hover       { color: blue;  background-color: transparent; text-decoration: underline; }
  91 |           .nohover      { pointer-events: none; }
  92 |           @media print  { .noprint { display: none; } thead { display: table-header-group; } .rotate { padding: 0px 0px 0px 0px; margin: 0px; } }
  93 |           .noprint      { position: fixed; bottom: 0.5em; right: 0.5em; z-index: 99; }
  94 |           .rotate span  { writing-mode: vertical-rl; transform: rotate(180deg); white-space: nowrap; }
  95 |           .noborder     { border: none; }
  96 |           .center       { margin-left: auto; margin-right: auto; }
  97 |           .matrix       { text-align: center; }
  98 |           .check        { color: DarkGreen; }
  99 |           .hidden       { visibility: hidden; display: none; }
 100 |           .maintable    { border: 1px; width: 100%; }
 101 |           .crfhead      { background-color: Gainsboro; }
 102 |           .left         { text-align: left; }
 103 |           .formtitle    { font-style: bold;   font-weight: bold;   font-size: 1.2em; }
 104 |           .note         { font-style: italic; font-weight: normal; font-size: 0.8em; }
 105 |           .plain        { font-weight: normal; }
 106 |           .small        { font-size: 0.7em; vertical-align: midddle;}
 107 |           .inpw         { width: 40%; }
 108 |           .maxw         { width: 100%; }
 109 |           .seqw         { width: 5em !important; }
 110 |           .cdash        { background-color: lightblue; padding: 2px; color: Blue; border: 2px double Blue !important; }
 111 |           <xsl:choose>
 112 |             <xsl:when test="$parmdisplay = 'spec' or $parmdisplay = 'acrf' or normalize-space($parmdisplay) = ''">
 113 |               .anno     { background-color: LightYellow; }
 114 |               .quew     { width: 30%; }
 115 |               .answ     { width: 25%; }
 116 |               .annw     { width: 40%; }
 117 |               .desw     { width: 60%; }
 118 |             </xsl:when>
 119 |             <xsl:otherwise>
 120 |               .anno     { visibility: hidden; display: none; }
 121 |               .quew     { width:  50%; }
 122 |               .answ     { width:  45%; }
 123 |               .desw     { width: 100%; }
 124 |             </xsl:otherwise>
 125 |           </xsl:choose>
 126 |           <xsl:if test="$parmdisplay != 'spec' and normalize-space($parmdisplay) != ''">
 127 |               #internal { visibility: hidden; display: none; }
 128 |           </xsl:if>
 129 |         </style>
 130 |       </head>
 131 |       <body>
 132 |         <xsl:call-template name="buttons"/>
 133 |         <xsl:apply-templates select="/odm:ODM/odm:Study[1]/odm:GlobalVariables"/>
 134 |         <xsl:apply-templates select="/odm:ODM"/>
 135 | <!--
 136 |         <xsl:value-of select="$parmlang"/>
 137 | -->
 138 | 
 139 |         <p style="page-break-before: always; margin-top: 0;"/>
 140 | 
 141 |         <!-- Either Toc or Visit Matrix for navigation -->
 142 |         <xsl:if test="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:StudyEventDef">
 143 |           <xsl:call-template name="visit_matrix"/>
 144 |           <p style="page-break-before: always; margin-top: 0;"/>
 145 |         </xsl:if>
 146 |         <xsl:call-template name="toc"/>
 147 | 
 148 |         <xsl:choose>
 149 |           <xsl:when test="$parmdisplay = 'book'">
 150 |             <!-- for each visit, for each form -->
 151 |             <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:Protocol/odm:StudyEventRef">
 152 |               <xsl:sort select="@OrderNumber" data-type="number"/>
 153 |               <xsl:variable name="studyeventoid" select="@StudyEventOID"/>
 154 |               <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:StudyEventDef[@OID=$studyeventoid]/odm:FormRef">
 155 |                 <xsl:sort select="key('by_FormRef', @OID)/@OrderNumber" data-type="number"/>
 156 |                 <xsl:variable name="formoid"   select="@FormOID"/>
 157 |                 <xsl:variable name="visitname" select="../@Name"/>
 158 |                 <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:FormDef[@OID=$formoid]">
 159 |                   <xsl:call-template name="one_form">
 160 |                     <xsl:with-param name="vis_target" select="$studyeventoid"/>
 161 |                     <xsl:with-param name="vis_name"   select="$visitname"/>
 162 |                   </xsl:call-template>
 163 |                 </xsl:for-each>
 164 |               </xsl:for-each>
 165 |             </xsl:for-each>
 166 |           </xsl:when>
 167 |           <xsl:otherwise>
 168 |             <!-- One table per form becomes one form per page -->
 169 |             <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:FormDef">
 170 |               <!-- If visit structure is not present, forms will be sorted in FormDef tag order of the ODM file itself -->
 171 |               <xsl:sort select="key('by_StudyEventRef', key('by_FormRef', @OID)/../@OID)/@OrderNumber" data-type="number"/>
 172 |               <xsl:sort select="key('by_FormRef', @OID)/@OrderNumber" data-type="number"/>
 173 |               <xsl:call-template name="one_form"/>
 174 |             </xsl:for-each>
 175 |           </xsl:otherwise>
 176 |         </xsl:choose>
 177 | 
 178 |       </body>
 179 |     </html>
 180 |   </xsl:template>
 181 | 
 182 |   <!-- Show one Form -->
 183 |   <xsl:template name="one_form">
 184 |     <xsl:param name="vis_target"/>
 185 |     <xsl:param name="vis_name"/>
 186 |     <table class="maintable">
 187 |       <p style="page-break-before: always;"/>
 188 |       <xsl:call-template name="table_head">
 189 |         <xsl:with-param name="visit_target" select="$vis_target"/>
 190 |         <xsl:with-param name="visit_name"   select="$vis_name"/>
 191 |       </xsl:call-template>
 192 |       <tbody>
 193 |         <xsl:for-each select="odm:ItemGroupRef">
 194 |           <xsl:sort select="@OrderNumber" data-type="number"/>
 195 |           <xsl:variable name="group" select="@ItemGroupOID"/>
 196 |           <xsl:variable name="gnum"  select="@OrderNumber"/>
 197 |           <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:ItemGroupDef[@OID=$group]">
 198 |             <xsl:variable name="domain" select="@Domain"/>
 199 |             <xsl:if test="$parmoids = '1'">
 200 |               <xsl:call-template name="section"/>
 201 |             </xsl:if>
 202 |             <xsl:for-each select="odm:ItemRef">
 203 |               <xsl:sort select="@OrderNumber" data-type="number"/>
 204 |               <xsl:variable name="item" select="@ItemOID"/>
 205 |               <xsl:variable name="inum" select="@OrderNumber"/>
 206 |               <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:ItemDef[@OID=$item]">
 207 |                 <tr>
 208 |                   <td class="seqw">
 209 |                     <xsl:call-template name="sequence_number">
 210 |                       <xsl:with-param name="major"    select="$gnum"/>
 211 |                       <xsl:with-param name="minor"    select="$inum"/>
 212 |                       <xsl:with-param name="has_note" select="normalize-space(
 213 |                         odm:Alias[@Context='implementationNotes']/@Name)
 214 |                           != ''"/> <!-- Implementation Notes -->
 215 |                     </xsl:call-template>
 216 |                   </td>
 217 |                   <td class="quew">
 218 |                     <xsl:call-template name="question"/>
 219 |                   </td>
 220 |                   <td class="answ">
 221 |                     <xsl:call-template name="answer"/>
 222 |                   </td>
 223 |                   <td id="anno" class="annw anno">
 224 |                     <xsl:if test="odm:Alias[@Context='Target']/@Name">
 225 |                       <xsl:call-template name="define_anchor">
 226 |                         <xsl:with-param name="target" select="odm:Alias[@Context='Target']/@Name"/>
 227 |                       </xsl:call-template>
 228 |                     </xsl:if>
 229 |                     <xsl:call-template name="annotation">
 230 |                       <xsl:with-param name="domain" select="$domain"/>
 231 |                     </xsl:call-template>
 232 |                   </td>
 233 |                 </tr>
 234 |               </xsl:for-each>
 235 |             </xsl:for-each>
 236 |           </xsl:for-each>
 237 |         </xsl:for-each>
 238 |       </tbody>
 239 |     </table>
 240 |     <xsl:call-template name="form_notes"/>
 241 |   </xsl:template>
 242 | 
 243 |   <!-- Non printable buttons to turn elements off and on.
 244 |        In-line JavaScript as SCRIPT sections will not execute and onload() will not fire -->
 245 |   <xsl:template name="buttons">
 246 |     <table class="noprint">
 247 |       <tr>
 248 |         <xsl:if test="$parmoids = '1'">
 249 |           <td class="noborder">
 250 |             <button onClick="for(var element of document.querySelectorAll('[id=oids]')) element.style.visibility = (element.style.visibility == 'collapse') ? 'visible' : 'collapse';">
 251 |               Identifiers Off and On
 252 |             </button>
 253 |           </td>
 254 |         </xsl:if>
 255 |         <xsl:if test="$parmdisplay = 'spec' or normalize-space($parmdisplay) = ''">
 256 |           <td class="noborder">
 257 |             <button onClick="for(var element of document.querySelectorAll('[id=anno]')) element.style.visibility   = (element.style.visibility   == 'collapse') ? 'visible' : 'collapse';
 258 |                              for(var element of document.querySelectorAll('[id=anno]')) element.style.borderRight  = (element.style.borderRight  == '0px') ? '1px solid Darkgrey' : '0px';
 259 |                              for(var element of document.querySelectorAll('[id=anno]')) element.style.borderBottom = (element.style.borderBottom == '0px') ? '1px solid Darkgrey' : '0px';
 260 |                              for(var element of document.querySelectorAll('[id=anno]')) element.style.borderTop    = (element.style.borderTop    == '0px') ? '1px solid Darkgrey' : '0px';">
 261 |               SDTM annotations Off and On
 262 |             </button>
 263 |           </td>
 264 |           <td class="noborder">
 265 |             <button onClick="for(var element of document.querySelectorAll('[id=internal]')) element.style.visibility = (element.style.visibility == 'collapse') ? 'visible' : 'collapse';">
 266 |               Internal notes Off and On
 267 |             </button>
 268 |           </td>
 269 |           <td class="noborder">
 270 |             <button onClick="for(var element of document.querySelectorAll('[id=implement]')) element.style.visibility = (element.style.visibility == 'collapse') ? 'visible' : 'collapse';">
 271 |               Implementation notes Off and On
 272 |             </button>
 273 |           </td>
 274 |         </xsl:if>
 275 |         <xsl:if test=".//odm:Alias[@Context='completionInstructions']/@Name">
 276 |           <td class="noborder">
 277 |             <button onClick="for(var element of document.querySelectorAll('[id=complete]')) element.style.visibility = (element.style.visibility == 'collapse') ? 'visible' : 'collapse';">
 278 |               Completion instructions Off and On
 279 |             </button>
 280 |           </td>
 281 |         </xsl:if>
 282 |         <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) != '') and $parmcdash = '1' and .//odm:Alias[@Context='CDASH']">
 283 |           <td class="noborder">
 284 |             <button onClick="for(var element of document.querySelectorAll('[id=cdash]')) element.style.visibility = (element.style.visibility == 'collapse') ? 'visible' : 'collapse';">
 285 |               CDASH annotations Off and On
 286 |             </button>
 287 |           </td>
 288 |         </xsl:if>
 289 |         <td class="noborder">
 290 |           <button onClick="document.documentElement.scrollTop = 0">
 291 |             Scroll to the top
 292 |           </button>
 293 |         </td>
 294 |       </tr>
 295 |     </table>
 296 |   </xsl:template>
 297 | 
 298 |   <!-- Identifier for title and name -->
 299 |   <xsl:template name="identifier">
 300 |     <xsl:choose>
 301 |       <xsl:when test="normalize-space(/odm:ODM/odm:Study[1]/odm:GlobalVariables/odm:StudyName) = 'Not applicable' and normalize-space($parmstudy) != ''">
 302 |         <xsl:value-of select="$parmstudy"/>
 303 |       </xsl:when>
 304 |       <xsl:when test="normalize-space(/odm:ODM/odm:Study[1]/odm:GlobalVariables/odm:StudyName) = 'Not applicable'">
 305 |         Standard
 306 |       </xsl:when>
 307 |       <xsl:otherwise>
 308 |         <xsl:value-of select="/odm:ODM/odm:Study[1]/odm:GlobalVariables/odm:StudyName"/>
 309 |       </xsl:otherwise>
 310 |     </xsl:choose>
 311 |   </xsl:template>
 312 | 
 313 |  <!-- Title Page -->
 314 |   <xsl:template match="/odm:ODM/odm:Study[1]/odm:GlobalVariables">
 315 |     <xsl:choose>
 316 |       <xsl:when test="$parmdisplay = 'book'">
 317 |         <h1>CRF Book</h1>
 318 |       </xsl:when>
 319 |       <xsl:when test="normalize-space(/odm:ODM/odm:Study[1]/odm:GlobalVariables/odm:StudyName) = 'Not applicable'">
 320 |         <h1>Standard</h1>
 321 |       </xsl:when>
 322 |       <xsl:otherwise>
 323 |         <h1>Study</h1>
 324 |       </xsl:otherwise>
 325 |     </xsl:choose>
 326 |     <h1>CRF Specification for <xsl:call-template name="identifier"/></h1>
 327 |     <xsl:if test="$parmversion != ''">
 328 |       <h3><xsl:value-of select="$parmversion"/></h3>
 329 |     </xsl:if>
 330 |     <xsl:if test="$parmstatus != ''">
 331 |       <h3>Status: <xsl:value-of select="$parmstatus"/></h3>
 332 |     </xsl:if>
 333 |     <xsl:if test="normalize-space(odm:StudyDescription) != 'Not applicable'">
 334 |       <p><xsl:value-of select="odm:StudyDescription"/></p>
 335 |     </xsl:if>
 336 |     <xsl:if test="normalize-space(odm:StudyName) != normalize-space(odm:ProtocolName) and normalize-space(odm:ProtocolName) != 'Not applicable' and normalize-space(odm:ProtocolName) != ''">
 337 |       <h2>Protocol Name: <xsl:value-of select="odm:ProtocolName"/></h2>
 338 |     </xsl:if>
 339 |   </xsl:template>
 340 | 
 341 |   <!-- Title Dates -->
 342 |   <xsl:template match="/odm:ODM">
 343 |     <xsl:if test="normalize-space(@CreationDateTime) != ''">
 344 |       <p>
 345 |         Creation date: <xsl:value-of select="substring-before(@CreationDateTime, 'T')"/>
 346 |         time: <xsl:value-of select="substring-before(substring-after(@CreationDateTime, 'T'), '+')"/>
 347 |       </p>
 348 |     </xsl:if>
 349 |     <xsl:if test="normalize-space(@AsOfDateTime) != ''">
 350 |       <p>
 351 |         Valid from date: <xsl:value-of select="substring-before(@AsOfDateTime, 'T')"/>
 352 |         time: <xsl:value-of select="substring-before(substring-after(@AsOfDateTime, 'T'), '+')"/>
 353 |       </p>
 354 |     </xsl:if>
 355 |     <h3><xsl:value-of select="$parmname"/></h3>
 356 |     <p>
 357 |       <img>
 358 |         <xsl:attribute name="src">
 359 |           <xsl:if test="not(contains($parmlogo, '.'))">data:image/png;base64,</xsl:if><xsl:value-of select="$parmlogo"/>
 360 |         </xsl:attribute>
 361 |       </img>
 362 |     </p>
 363 |   </xsl:template>
 364 | 
 365 |   <!-- Toc, Alfabetic sorting of Forms by name -->
 366 |   <xsl:template name="toc">
 367 |     <table class="center maxw">
 368 |       <thead>
 369 |         <tr>
 370 |           <td class="noborder" colspan="3">
 371 |             <h2 class="center">Table of Contents</h2>
 372 |           </td>
 373 |         </tr>
 374 |       </thead>
 375 |       <tbody>
 376 |         <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:FormDef">
 377 |           <xsl:sort select="@Name" data-type="text"/>
 378 |           <tr>
 379 |             <td colspan="3" class="noborder matrix">
 380 |               <xsl:call-template name="form_link">
 381 |                 <xsl:with-param name="name"  select="@Name"/>
 382 |                 <xsl:with-param name="oid"   select="@OID"/>
 383 |               </xsl:call-template>
 384 |               <p/>
 385 |             </td>
 386 |           </tr>
 387 |         </xsl:for-each>
 388 |       </tbody>
 389 |     </table>
 390 |   </xsl:template>
 391 | 
 392 |   <!-- Vist Matrix -->
 393 |   <xsl:template name="visit_matrix">
 394 |     <table class="center">
 395 |       <thead>
 396 |         <tr>
 397 |           <td class="noborder" colspan="99">
 398 |             <h2 class="center">Visit Matrix</h2>
 399 |           </td>
 400 |         </tr>
 401 |         <tr>
 402 |           <th class="left crfhead">Event/<br/>Form</th>
 403 |           <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:Protocol/odm:StudyEventRef">
 404 |             <xsl:sort select="@OrderNumber" data-type="number"/>
 405 |             <xsl:variable name="visithead" select="@StudyEventOID"/>
 406 |             <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:StudyEventDef[@OID=$visithead]">
 407 |               <th class="crfhead rotate plain">
 408 |                 <xsl:choose>
 409 |                   <xsl:when test="$parmdisplay = 'book'">
 410 |                     <span>
 411 |                       <a>
 412 |                         <xsl:attribute name="href">#<xsl:value-of select="$visithead"/></xsl:attribute>
 413 |                         <xsl:value-of select="@Name"/>
 414 |                       </a>
 415 |                     </span>
 416 |                   </xsl:when>
 417 |                   <xsl:otherwise>
 418 |                     <span><xsl:value-of select="@Name"/></span>
 419 |                   </xsl:otherwise>
 420 |                 </xsl:choose>
 421 |               </th>
 422 |             </xsl:for-each>
 423 |           </xsl:for-each>
 424 |         </tr>
 425 |       </thead>
 426 |       <tbody>
 427 |         <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:FormDef">
 428 |           <xsl:sort select="key('by_StudyEventRef', key('by_FormRef', @OID)/../@OID)/@OrderNumber" data-type="number"/>
 429 |           <xsl:sort select="key('by_FormRef', @OID)/@OrderNumber" data-type="number"/>
 430 |           <xsl:variable name="formrow" select="@OID"/>
 431 |           <tr>
 432 |             <td>
 433 |               <xsl:call-template name="form_link">
 434 |                 <xsl:with-param name="name"  select="@Name"/>
 435 |                 <xsl:with-param name="oid"   select="@OID"/>
 436 |               </xsl:call-template>
 437 |               <xsl:if test="contains(
 438 |                 odm:Alias[@Context='implementationNotes']/@Name,
 439 |                   'Repeating form')"> <!-- Implementation Notes. Candidate for deletion -->
 440 |                 <em class="check"> [<xsl:text>&#8734;</xsl:text>]</em> <!-- ∞ -->
 441 |               </xsl:if>
 442 |             </td>
 443 |             <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:Protocol/odm:StudyEventRef">
 444 |               <xsl:sort select="@OrderNumber" data-type="number"/>
 445 |               <td class="matrix check">
 446 |                 <xsl:variable name="visitbody"  select="@StudyEventOID"/>
 447 |                 <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:StudyEventDef[@OID=$visitbody]">
 448 |                   <xsl:for-each select="odm:FormRef">
 449 |                     <xsl:if test="$formrow = @FormOID">
 450 |                       <xsl:text>&#10004;</xsl:text> <!-- ✔ -->
 451 |                     </xsl:if>
 452 |                   </xsl:for-each>
 453 |                 </xsl:for-each>
 454 |               </td>
 455 |             </xsl:for-each>
 456 |           </tr>
 457 |         </xsl:for-each>
 458 |       </tbody>
 459 |     </table>
 460 |   </xsl:template>
 461 | 
 462 |   <!-- The header of the main table is complex enough to have it's own template -->
 463 |   <xsl:template name="table_head">
 464 |     <xsl:param name="visit_target"/>
 465 |     <xsl:param name="visit_name"/>
 466 |     <thead>
 467 |       <xsl:if test="$parmdisplay = 'book'">
 468 |         <tr>
 469 |           <th colspan="4" class="noborder">
 470 |             <table class="maintable">
 471 |               <tr>
 472 |                 <td class="plain small" rowspan="2">
 473 |                   <xsl:if test="$parmlogo != ''">
 474 |                     <a class="nohover">
 475 |                       <xsl:attribute name="id">
 476 |                         <xsl:value-of select="$visit_target"/>
 477 |                       </xsl:attribute>
 478 |                       <img height="40">
 479 |                         <xsl:attribute name="src">
 480 |                           <xsl:if test="not(contains($parmlogo, '.'))">data:image/png;base64,</xsl:if><xsl:value-of select="$parmlogo"/>
 481 |                         </xsl:attribute>
 482 |                       </img>
 483 |                     </a>
 484 |                   </xsl:if>
 485 |                 </td>
 486 |                 <td class="formtitle">
 487 |                   <xsl:if test="$parmname != ''">
 488 |                     <xsl:value-of select="$parmname"/>
 489 |                   </xsl:if>
 490 |                 </td>
 491 |                 <td class="formtitle">
 492 |                   <xsl:call-template name="identifier"/>
 493 |                 </td>
 494 |                 <td class="plain small">
 495 |                   <xsl:value-of select="$parmversion"/>
 496 |                   <xsl:text> </xsl:text>
 497 |                   <xsl:value-of select="$parmstatus"/>
 498 |                 </td>
 499 |               </tr>
 500 |               <tr>
 501 |                 <td class="plain small">
 502 |                   Site <input type="text" class="inpw"/>
 503 |                 </td>
 504 |                 <td class="plain small">
 505 |                   Subject identifier <input type="text" class="inpw"/>
 506 |                 </td>
 507 |                 <td class="plain small">
 508 |                   <xsl:value-of select="$visit_name"/>
 509 |                 </td>
 510 |               </tr>
 511 |               <tr><th colspan="4" class="noborder"><br/></th></tr>
 512 |             </table>
 513 |           </th>
 514 |         </tr>
 515 |       </xsl:if>
 516 |       <tr>
 517 |         <th colspan="4" class="noborder">
 518 |           <div class="left formtitle">
 519 |             <a class="nohover">
 520 |               <xsl:attribute name="id">
 521 |                 <xsl:value-of select="@OID"/>
 522 |               </xsl:attribute>
 523 |               <span>
 524 |                 <xsl:value-of select="@Name"/>
 525 |               </span>
 526 |             </a>
 527 |             <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) = '') and
 528 |                              normalize-space(odm:Alias[@Context='implementationNotes']/@Name) != ''">
 529 |                                <!-- Implementation Notes -->
 530 |               <text id="implement"> #</text>
 531 |             </xsl:if>
 532 |             <xsl:if test="$parmoids = '1'">
 533 |               <span id="oids" class="note">
 534 |                 <br/>FormDef OID = <xsl:value-of select="@OID"/>
 535 |               </span>
 536 |             </xsl:if>
 537 |           </div>
 538 |         </th>
 539 |       </tr>
 540 |       <xsl:if test="normalize-space(
 541 |         odm:Alias[@Context='completionInstructions']/@Name)
 542 |           != ''"> <!-- Completion Instructions. Candidate for deletion -->
 543 |         <tr id="complete">
 544 |           <th colspan="4" class="noborder left note">
 545 |             <xsl:apply-templates select=
 546 |               "odm:Alias[@Context='completionInstructions']/@Name"/>
 547 |                 <!-- Completion Instructions. Candidate for deletion -->
 548 |           </th>
 549 |         </tr>
 550 |       </xsl:if>
 551 |       <xsl:if test="odm:Description">
 552 |         <tr id="internal">
 553 |           <th colspan="4" class="noborder">
 554 |             <xsl:apply-templates select="odm:Description"/>
 555 |           </th>
 556 |         </tr>
 557 |       </xsl:if>
 558 |       <tr><th colspan="4" class="noborder"><br/></th></tr>
 559 |       <tr>
 560 |         <th class="crfhead seqw left">Ref</th>
 561 |         <th class="crfhead quew">CRF Question</th>
 562 |         <th class="crfhead answ">Data Collected</th>
 563 |         <xsl:if test="$parmdisplay = 'spec' or normalize-space($parmdisplay) = '' or $parmdisplay = 'acrf'">
 564 |           <th class="crfhead annw" id="anno">SDTM Annotations</th>
 565 |         </xsl:if>
 566 |       </tr>
 567 |     </thead>
 568 |   </xsl:template>
 569 | 
 570 | <!--
 571 |   <xsl:template name="translatedtext">
 572 |     <xsl:param name="text"/>
 573 |     <xsl:param name="lang"/>
 574 |     <xsl:choose>
 575 |       <xsl:when test="normalize-space($lang) = ''">
 576 |         <xsl:value-of select="$text"/>
 577 |       </xsl:when>
 578 |       <xsl:when test="string-length($lang) = 2">
 579 |         <xsl:value-of
 580 |       </xsl:when>
 581 |       <xsl:otherwise>
 582 |         <xsl:value-of select="$text"/>
 583 |       </xsl:otherwise>
 584 |     </xsl:choose>
 585 |   </xsl:template>
 586 | 
 587 | -->
 588 |   <!-- Add Note from Description/TranslatedText to Forms -->
 589 |   <xsl:template match="odm:Description">
 590 |     <div id="internal" class="left note">
 591 |       <xsl:value-of select="odm:TranslatedText"/> <!-- Implementation Notes -->
 592 |     </div>
 593 |   </xsl:template>
 594 | 
 595 |   <!-- Create a link to a form -->
 596 |   <xsl:template name="form_link">
 597 |     <xsl:param name="name"/>
 598 |     <xsl:param name="oid"/>
 599 |     <a>
 600 |       <xsl:attribute name="href">#<xsl:value-of select="$oid"/></xsl:attribute>
 601 |       <span>
 602 |         <xsl:value-of select="$name"/>
 603 |       </span>
 604 |     </a>
 605 |   </xsl:template>
 606 | 
 607 |   <!-- Show a section -->
 608 |   <xsl:template name="section">
 609 |     <tr id="oids">
 610 |       <td class="seqw"/>
 611 |       <td class="quew note">
 612 |         ItemGroupDef OID = <xsl:value-of select="@OID"/>
 613 |       </td>
 614 |       <td class="answ"/>
 615 |       <td class="annw anno" id="anno"/>
 616 |     </tr>
 617 |   </xsl:template>
 618 | 
 619 |   <!-- Show the sequence number as a reference to each question -->
 620 |   <xsl:template name="sequence_number">
 621 |     <xsl:param name="major"/>
 622 |     <xsl:param name="minor"/>
 623 |     <xsl:param name="has_note"/>
 624 |     <xsl:value-of select="$major"/>.<xsl:value-of select="$minor"/>
 625 |     <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) = '') and $has_note">
 626 |       <text id="implement"> #</text>
 627 |     </xsl:if>
 628 |   </xsl:template>
 629 | 
 630 |   <!-- Show one question on the form, including guidance text and completion note -->
 631 |   <xsl:template name="question">
 632 |     <xsl:if test="$parmoids = '1'">
 633 |       <div id="oids" class="note">
 634 |         ItemDef OID = <xsl:value-of select="@OID"/>
 635 |       </div>
 636 |     </xsl:if>
 637 |     <xsl:choose>
 638 |       <xsl:when test="odm:Question/odm:TranslatedText">
 639 |         <xsl:value-of select="odm:Question/odm:TranslatedText"/>
 640 |       </xsl:when>
 641 |       <xsl:otherwise>
 642 |         <xsl:value-of select="@Name"/>
 643 |       </xsl:otherwise>
 644 |     </xsl:choose>
 645 |     <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) = '') and odm:Alias[@Context='prompt']">
 646 |       <xsl:value-of select="odm:Alias[@Context='prompt']"/>
 647 |     </xsl:if>
 648 |     <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) = '') and odm:Alias[@Context='prompt']">
 649 |       <p class="left">
 650 |         PROMPT:
 651 |         <xsl:value-of select="odm:Alias[@Context='prompt']/@Name"/>
 652 |       </p> <!-- Prompt text for data entry -->
 653 |     </xsl:if>
 654 |     <xsl:if test="odm:Alias[@Context='completionInstructions']/@Name">
 655 |       <p class="note left" id="complete"><xsl:value-of select="odm:Alias[@Context='completionInstructions']/@Name"/></p> <!-- Completion Instructions -->
 656 |     </xsl:if>
 657 | <!--
 658 |     Description at question level contains a repeat of the CDASH Alias in all the CDISC ePortal forms
 659 |     <xsl:apply-templates select="odm:Description"/>
 660 | -->
 661 |   </xsl:template>
 662 | 
 663 |   <!-- Collect the data as answer to the question -->
 664 |   <xsl:template name="answer">
 665 |     <xsl:if test="$parmoids = '1' and odm:CodeListRef/@CodeListOID">
 666 |       <div id="oids" class="note">
 667 |         CodeList OID = <xsl:value-of select="odm:CodeListRef/@CodeListOID"/>
 668 |       </div>
 669 |     </xsl:if>
 670 |     <xsl:choose>
 671 |       <!-- Questions having the text 'all that apply' associated anywhere are data type Checkbox -->
 672 |       <xsl:when test="contains(@Name,                                              'all that apply') or
 673 |                       contains(odm:Question/odm:TranslatedText,                    'all that apply') or
 674 |                       contains(odm:Description/odm:TranslatedText,                 'all that apply') or
 675 |                       contains(odm:Alias[@Context='completionInstructions']/@Name, 'all that apply')">
 676 |         <xsl:variable name="check" select="odm:CodeListRef/@CodeListOID"/>
 677 |         <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:CodeList/odm:CodeListItem[../@OID=$check]">
 678 |           <xsl:sort select="@OrderNumber" data-type="number"/>
 679 |           <input type="checkbox" name="$check"/><label for="$check"><xsl:value-of select="odm:Decode/odm:TranslatedText"/><span class="note"> (<xsl:value-of select="@CodedValue"/>)</span></label><br/>
 680 |         </xsl:for-each>
 681 |       </xsl:when>
 682 |       <!-- Questions having code lists associates without the text 'all that apply' are data type Radio buttons -->
 683 |       <xsl:when test="normalize-space(odm:CodeListRef/@CodeListOID) != ''">
 684 |         <xsl:variable name="radio" select="odm:CodeListRef/@CodeListOID"/>
 685 |         <!-- CodeListItem and EnumeratedItem are mutually exclusive, thus processing them in sequence displays only the one having data -->
 686 |         <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:CodeList/odm:CodeListItem[../@OID=$radio]">
 687 |           <xsl:sort select="@OrderNumber" data-type="number"/>
 688 |           <xsl:variable name="radioname" select="translate(../@OID, ' ', '_')"/>
 689 |           <input type="radio">
 690 |             <xsl:attribute name="name">
 691 |               <xsl:value-of select="$radioname"/>
 692 |             </xsl:attribute>
 693 |           </input>
 694 |           <label>
 695 |             <xsl:attribute name="for">
 696 |               <xsl:value-of select="$radioname"/>
 697 |             </xsl:attribute>
 698 |             <xsl:value-of select="odm:Decode/odm:TranslatedText"/>
 699 |             <xsl:if test="normalize-space(odm:Decode/odm:TranslatedText) = ''">
 700 |               <xsl:value-of select="@CodedValue"/>
 701 |             </xsl:if>
 702 |             <span class="note"> (<xsl:value-of select="@CodedValue"/>)</span>
 703 |           </label>
 704 |           <br/>
 705 |         </xsl:for-each>
 706 |         <!-- Enumerated codelists are simple radio buttons -->
 707 |         <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:CodeList/odm:EnumeratedItem[../@OID=$radio]">
 708 |           <xsl:sort select="@Rank" data-type="number"/>
 709 |           <xsl:variable name="enumname" select="translate(../@OID, ' ', '_')"/>
 710 |           <input type="radio">
 711 |             <xsl:attribute name="name">
 712 |               <xsl:value-of select="$enumname"/>
 713 |             </xsl:attribute>
 714 |           </input>
 715 |           <label>
 716 |             <xsl:attribute name="for">
 717 |               <xsl:value-of select="$enumname"/>
 718 |             </xsl:attribute>
 719 |             <span class="note"><xsl:value-of select="@CodedValue"/></span>
 720 |           </label><br/>
 721 |         </xsl:for-each>
 722 |       </xsl:when>
 723 |       <!-- Data type integer -->
 724 |       <xsl:when test="@DataType = 'integer'">
 725 |         <input type="number"/><span class="note"> Integer</span>
 726 |       </xsl:when>
 727 |       <!-- Data type float -->
 728 |       <xsl:when test="@DataType = 'float'">
 729 |         <input type="number"/><span class="note"> Floating point (<xsl:value-of select="@Length"/>.<xsl:value-of select="@SignificantDigits"/>)</span>
 730 |       </xsl:when>
 731 |       <!-- Data type date -->
 732 |       <xsl:when test="@DataType = 'date'">
 733 |         <input type="text" placeholder="DD-MMM-YYYY"/><span class="note"> Date</span>
 734 |         <p class="note left">
 735 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM
 736 |         </p>
 737 |       </xsl:when>
 738 |       <!-- Data type time -->
 739 |       <xsl:when test="@DataType = 'time'">
 740 |         <input type="text" placeholder="HH:MM"/><span class="note"> Time</span>
 741 |         <p class="note left">
 742 |           Always collect times as HH:MM and store times as ISO8601 in SDTM
 743 |         </p>
 744 |       </xsl:when>
 745 |       <!-- Data type text -->
 746 |       <xsl:when test="@DataType = 'text'">
 747 |         <input type="text"/><span class="note"> Text</span>
 748 |       </xsl:when>
 749 |       <!-- Data type boolean -->
 750 |       <xsl:when test="@DataType = 'boolean'">
 751 |         <xsl:variable name="boolname" select="translate(@OID, ' ', '_')"/>
 752 |         <input type="checkbox">
 753 |           <xsl:attribute name="name">
 754 |             <xsl:value-of select="$boolname"/>
 755 |           </xsl:attribute>
 756 |         </input>
 757 |         <label>
 758 |           <xsl:attribute name="for">
 759 |             <xsl:value-of select="$boolname"/>
 760 |           </xsl:attribute>
 761 |           <xsl:value-of select="odm:Question/odm:TranslatedText"/>
 762 |           <span class="note"> (<xsl:value-of select="translate(odm:Question/odm:TranslatedText, $lowercase, $uppercase)"/>) Boolean</span>
 763 |         </label><br/>
 764 |       </xsl:when>
 765 |       <!-- Unknown data type is marked for debugging -->
 766 |       <xsl:otherwise>
 767 |         <input>
 768 |           <xsl:attribute name="type">
 769 |             <xsl:value-of select="@DataType"/><span class="note">UNKNOWN DATA TYPE</span>
 770 |           </xsl:attribute>
 771 |         </input>
 772 |       </xsl:otherwise>
 773 |     </xsl:choose>
 774 |     <xsl:if test="odm:MeasurementUnitRef">
 775 |       <xsl:variable name="unitoid" select="odm:MeasurementUnitRef/@MeasurementUnitOID"/>
 776 |       <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:BasicDefinitions/odm:MeasurementUnit[@OID=$unitoid]">
 777 |         <xsl:variable name="unitname" select="translate(@OID, ' ', '_')"/>
 778 |         <br/>
 779 |         <input type="radio">
 780 |           <xsl:attribute name="name">
 781 |             <xsl:value-of select="$unitname"/>
 782 |           </xsl:attribute>
 783 |         </input>
 784 |         <label>
 785 |           <xsl:attribute name="for">
 786 |             <xsl:value-of select="$unitname"/>
 787 |           </xsl:attribute>
 788 |           <span class="note">Unit
 789 |             (<xsl:value-of select="odm:Symbol/odm:TranslatedText"/>)
 790 |           </span>
 791 |         </label>
 792 |       </xsl:for-each>
 793 |     </xsl:if>
 794 |     <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) = '') and $parmcdash = '1' and odm:Alias[@Context='CDASH']">
 795 |       <table class="cdash left" id="cdash">
 796 |         <tr>
 797 |           <td>
 798 |             CDASH:
 799 |             <xsl:value-of select="normalize-space(odm:Alias[@Context='CDASH']/@Name)"/>
 800 |           </td>
 801 |         </tr>
 802 |       </table>
 803 |     </xsl:if>
 804 |   </xsl:template>
 805 | 
 806 |   <!-- Show the SDTM annotation to the question -->
 807 |   <xsl:template name="annotation">
 808 |     <xsl:param name="domain"/>
 809 | 
 810 |     <!-- Dataset and Variable -->
 811 |     <xsl:choose>
 812 |       <!-- Dataset and variable are each in Domain and SDSVarname -->
 813 |       <xsl:when test="normalize-space($domain) != '' and normalize-space(@SDSVarName) != ''">
 814 |         <!-- Anchor for domain.variable -->
 815 |         <xsl:call-template name="define_anchor">
 816 |           <xsl:with-param name="target" select="concat($domain, '.', @SDSVarName)"/>
 817 |         </xsl:call-template>
 818 |         <!-- Anchor for variable alone -->
 819 |         <xsl:call-template name="define_anchor">
 820 |           <xsl:with-param name="target" select="@SDSVarName"/>
 821 |         </xsl:call-template>
 822 |         <xsl:value-of select="$domain"/>
 823 |         <xsl:text>.</xsl:text>
 824 |         <xsl:value-of select="@SDSVarName"/>
 825 |         <xsl:if test="odm:Alias[@Context='SDTM']/@Name">
 826 |           <xsl:text>,</xsl:text>
 827 |           <br/>
 828 |         </xsl:if>
 829 |       </xsl:when>
 830 |       <!-- Dataset and Variable are both in SDSVarname separated by a period -->
 831 |       <xsl:when test="normalize-space(@SDSVarName) != '' and contains(substring(@SDSVarName, 1, 9), '.')">
 832 |         <!-- Anchor for variable contents -->
 833 |         <xsl:call-template name="define_anchor">
 834 |           <xsl:with-param name="target" select="@SDSVarName"/>
 835 |         </xsl:call-template>
 836 |         <xsl:value-of select="@SDSVarName"/>
 837 |         <xsl:if test="odm:Alias[@Context='SDTM']/@Name">
 838 |           <xsl:text>,</xsl:text>
 839 |           <br/>
 840 |         </xsl:if>
 841 |       </xsl:when>
 842 |         <!-- No dataset or variable specified, annotation expected in Alias only -->
 843 |       <xsl:otherwise/>
 844 |     </xsl:choose>
 845 | 
 846 |     <!-- Additional annotations beyond Dataset and Variable -->
 847 |     <xsl:choose>
 848 |       <!-- Variable with an optional Dataset prefix are in Alias -->
 849 |       <xsl:when test="contains(odm:Alias[@Context='SDTM']/@Name, ',') and
 850 |                       not(contains(substring-before(odm:Alias[@Context='SDTM']/@Name, ','), '=')) and
 851 |                       not(contains(substring-before(odm:Alias[@Context='SDTM']/@Name, ','), ' '))">
 852 |         <xsl:call-template name="define_anchor">
 853 |           <xsl:with-param name="target" select="substring-before(odm:Alias[@Context='SDTM']/@Name, ',')"/>
 854 |         </xsl:call-template>
 855 |         <xsl:value-of select="substring-before(odm:Alias[@Context='SDTM']/@Name, ',')"/>
 856 |         <xsl:text>,</xsl:text>
 857 |         <br/>
 858 |         <xsl:call-template name="annotation_text">
 859 |           <xsl:with-param name="text_line" select="substring-after(odm:Alias[@Context='SDTM']/@Name, ',')"/>
 860 |         </xsl:call-template>
 861 |       </xsl:when>
 862 |       <!-- Alias contains only additional annotations -->
 863 |       <xsl:when test="contains(odm:Alias[@Context='SDTM']/@Name, ',') or contains(odm:Alias[@Context='SDTM']/@Name, ' ')">
 864 |         <xsl:call-template name="annotation_text">
 865 |           <xsl:with-param name="text_line" select="odm:Alias[@Context='SDTM']/@Name"/>
 866 |         </xsl:call-template>
 867 |       </xsl:when>
 868 |       <!-- Alias contains only a Variable, with an optional Dataset prefix -->
 869 |       <xsl:otherwise>
 870 |         <xsl:call-template name="define_anchor">
 871 |           <xsl:with-param name="target" select="odm:Alias[@Context='SDTM']/@Name"/>
 872 |         </xsl:call-template>
 873 |         <xsl:call-template name="inline_anchor">
 874 |           <xsl:with-param name="inline" select="odm:Alias[@Context='SDTM']/@Name"/>
 875 |         </xsl:call-template>
 876 |         <xsl:value-of select="odm:Alias[@Context='SDTM']/@Name"/>
 877 |       </xsl:otherwise>
 878 |     </xsl:choose>
 879 |   </xsl:template>
 880 | 
 881 |   <!-- Link target for each word of text and splitting of lines -->
 882 |   <xsl:template name="annotation_text">
 883 |     <xsl:param name="text_line"/>
 884 |     <xsl:call-template name="anchor_words">
 885 |       <xsl:with-param name="text_string" select='translate($text_line, ",.=:-_ &apos;", "¤¤¤¤¤¤¤¤")'/>
 886 |     </xsl:call-template>
 887 |     <xsl:call-template name="break_lines">
 888 |       <xsl:with-param name="lines" select="normalize-space($text_line)"/>
 889 |     </xsl:call-template>
 890 |   </xsl:template>
 891 | 
 892 |   <!-- PDF anchor for define.xml. Also create a link to the target to preserve the target -->
 893 |   <xsl:template name="define_anchor">
 894 |     <xsl:param name="target"/>
 895 |     <xsl:if test="$target != '' and not(contains($target, ' '))">
 896 |       <a>
 897 |         <xsl:attribute name="href">
 898 |           #<xsl:value-of select="$target"/>
 899 |         </xsl:attribute>
 900 |       </a>
 901 |       <a class="nohover">
 902 |         <xsl:attribute name="id">
 903 |           <xsl:value-of select="$target"/>
 904 |         </xsl:attribute>
 905 |       </a>
 906 |     </xsl:if>
 907 |   </xsl:template>
 908 | 
 909 |   <!-- Replace occurences of '. ' (period blank) with HTML line break -->
 910 |   <xsl:template name="break_lines">
 911 |     <xsl:param name="lines"/>
 912 |     <xsl:choose>
 913 |       <xsl:when test="$lines = ''">
 914 |         <!-- Prevent this routine from hanging -->
 915 |         <xsl:value-of select="$lines"/>
 916 |       </xsl:when>
 917 |       <!-- Do not split lines when '. ' (period blank) occurs inside single quotes (abbreviations) -->
 918 |       <xsl:when test='contains($lines, ". ") and ((string-length(substring-before($lines, ". ")) - string-length(translate(substring-before($lines, ". "), "&apos;", ""))) mod 2 = 0 or not(contains($lines, "&apos;")))'>
 919 |         <xsl:call-template name="inline_anchor">
 920 |           <xsl:with-param name="inline" select="substring-before($lines, '. ')"/>
 921 |         </xsl:call-template>
 922 |         <xsl:value-of select="substring-before($lines, '. ')"/>.
 923 |         <br/>
 924 |         <xsl:call-template name="break_lines">
 925 |           <xsl:with-param name="lines" select="substring-after($lines, '. ')"/>
 926 |         </xsl:call-template>
 927 |       </xsl:when>
 928 |       <xsl:when test='contains($lines, ". ")'>
 929 |         <xsl:call-template name="inline_anchor">
 930 |           <xsl:with-param name="inline" select="$lines"/>
 931 |         </xsl:call-template>
 932 |         <xsl:value-of select="$lines"/>
 933 |       </xsl:when>
 934 |       <xsl:otherwise>
 935 |         <xsl:call-template name="inline_anchor">
 936 |           <xsl:with-param name="inline" select="$lines"/>
 937 |         </xsl:call-template>
 938 |         <xsl:value-of select="$lines"/>
 939 |       </xsl:otherwise>
 940 |     </xsl:choose>
 941 |   </xsl:template>
 942 | 
 943 |   <!-- Split a string into words -->
 944 |   <xsl:template name="anchor_words">
 945 |     <xsl:param name="text_string" select="''"/>
 946 |     <xsl:param name="separator" select="'¤'"/>
 947 |     <xsl:if test="not($text_string = '' or $separator = '')">
 948 |       <xsl:variable name="head" select="substring-before(concat($text_string, $separator), $separator)"/>
 949 |       <xsl:variable name="tail" select="substring-after($text_string, $separator)"/>
 950 |       <xsl:call-template name="define_anchor">
 951 |         <xsl:with-param name="target" select="$head"/>
 952 |       </xsl:call-template>
 953 |       <xsl:call-template name="anchor_words">
 954 |         <xsl:with-param name="text_string" select="$tail"/>
 955 |         <xsl:with-param name="separator" select="$separator"/>
 956 |       </xsl:call-template>
 957 |     </xsl:if>
 958 |   </xsl:template>
 959 | 
 960 |   <!-- Identify in-text Dataset.Variable constructs and create them a target -->
 961 |   <xsl:template name="inline_anchor">
 962 |     <xsl:param name="inline" select="''"/>
 963 |     <xsl:if test="normalize-space($inline) != ''">
 964 |       <xsl:if test="contains($inline, ',')">
 965 |         <xsl:call-template name="inline_anchor">
 966 |           <xsl:with-param name="inline" select="substring-after($inline, ',')"/>
 967 |         </xsl:call-template>
 968 |       </xsl:if>
 969 |       <xsl:if test="contains(substring-before($inline, '='), '.')">
 970 |         <xsl:call-template name="define_anchor">
 971 |           <xsl:with-param name="target" select="normalize-space(substring-before($inline, '='))"/>
 972 |         </xsl:call-template>
 973 |         <xsl:if test="contains(substring-after($inline, '='), '.') and not(contains(substring-after($inline, '='), ' ')) and not(contains(substring-after($inline, '='), ','))">
 974 |           <xsl:call-template name="define_anchor">
 975 |             <xsl:with-param name="target" select="normalize-space(substring-after($inline, '='))"/>
 976 |           </xsl:call-template>
 977 |         </xsl:if>
 978 |       </xsl:if>
 979 |     </xsl:if>
 980 |   </xsl:template>
 981 | 
 982 |   <!-- Show implementation notes for each question identified by the question reference number -->
 983 |   <xsl:template name="question_notes">
 984 |     <!-- Collect an indicator for each question implementation note for this form -->
 985 |     <xsl:if test="$parmdisplay = 'spec' or normalize-space($parmdisplay) = ''">
 986 |       <xsl:variable name="qnotes">
 987 |         <xsl:for-each select="odm:ItemGroupRef">
 988 |           <xsl:variable name="groupkey1" select="@ItemGroupOID"/>
 989 |           <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:ItemGroupDef[@OID=$groupkey1]">
 990 |             <xsl:for-each select="odm:ItemRef">
 991 |               <xsl:variable name="itemkey1" select="@ItemOID"/>
 992 |               <xsl:if test="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:ItemDef[@OID=$itemkey1]/odm:Alias[@Context='implementationNotes']/@Name"> <!-- Implementation Notes -->
 993 |                 Implementation note
 994 |               </xsl:if>
 995 |             </xsl:for-each>
 996 |           </xsl:for-each>
 997 |         </xsl:for-each>
 998 |       </xsl:variable>
 999 | 
1000 |       <!-- Question implementation note(s), if any -->
1001 |       <xsl:if test="normalize-space($qnotes) != ''">
1002 |         <p/>
1003 |         <table class="desw" id="implement">
1004 |           <thead>
1005 |             <tr><th class="left" colspan="2">Question implementation note(s)</th></tr>
1006 |           </thead>
1007 |           <tbody>
1008 |             <tr><td class="seqw">Question</td><td>Note</td></tr>
1009 |             <xsl:for-each select="odm:ItemGroupRef">
1010 |               <xsl:sort select="@OrderNumber" data-type="number"/>
1011 |               <xsl:variable name="groupnote" select="@ItemGroupOID"/>
1012 |               <xsl:variable name="gnumnote"  select="@OrderNumber"/>
1013 |               <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:ItemGroupDef[@OID=$groupnote]">
1014 |                 <xsl:for-each select="odm:ItemRef">
1015 |                   <xsl:sort select="@OrderNumber" data-type="number"/>
1016 |                   <xsl:variable name="itemnote" select="@ItemOID"/>
1017 |                   <xsl:variable name="inumnote" select="@OrderNumber"/>
1018 |                   <xsl:for-each select="/odm:ODM/odm:Study[1]/odm:MetaDataVersion[1]/odm:ItemDef[@OID=$itemnote]">
1019 |                     <xsl:variable name="questionnote" select="odm:Alias[@Context='implementationNotes']/@Name"/> <!-- Implementation Notes -->
1020 |                     <xsl:if test="normalize-space($questionnote) != ''">
1021 |                       <tr>
1022 |                         <td class="seqw">
1023 |                           <xsl:call-template name="sequence_number">
1024 |                             <xsl:with-param name="major"    select="$gnumnote"/>
1025 |                             <xsl:with-param name="minor"    select="$inumnote"/>
1026 |                             <xsl:with-param name="has_note" select="false"/>
1027 |                           </xsl:call-template>
1028 |                         </td>
1029 |                         <td class="note"><xsl:value-of select="$questionnote"/></td>
1030 |                       </tr>
1031 |                     </xsl:if>
1032 |                   </xsl:for-each>
1033 |                 </xsl:for-each>
1034 |               </xsl:for-each>
1035 |             </xsl:for-each>
1036 |           </tbody>
1037 |         </table>
1038 |       </xsl:if>
1039 |     </xsl:if>
1040 |   </xsl:template>
1041 | 
1042 |   <!-- Form implementation note, if any. Candidate for deletion -->
1043 |   <xsl:template name="form_notes">
1044 |     <xsl:if test="($parmdisplay = 'spec' or normalize-space($parmdisplay) = '') and
1045 |                     normalize-space(odm:Alias[@Context='implementationNotes']/@Name) != ''"> <!-- Implementation Notes -->
1046 |       <p/>
1047 |       <table class="desw" id="implement">
1048 |         <thead>
1049 |           <tr><th class="left">Form implementation note</th></tr>
1050 |         </thead>
1051 |         <tbody>
1052 |           <tr><td class="note"><xsl:value-of select="odm:Alias[@Context='implementationNotes']/@Name"/></td></tr> <!-- Implementation Notes -->
1053 |         </tbody>
1054 |       </table>
1055 |     </xsl:if>
1056 |     <xsl:call-template name="question_notes"/>
1057 |   </xsl:template>
1058 | </xsl:stylesheet>
1059 | 


--------------------------------------------------------------------------------
/examples/Test Trial bcrf.html:
--------------------------------------------------------------------------------
   1 | <!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01//EN" "http://www.w3.org/TR/html4/strict.dtd">
   2 | <html>
   3 | <head>
   4 | <title>Test Trial  </title>
   5 | <meta http-equiv="Content-Type" content="text/html;charset=utf-8">
   6 | <meta http-equiv="X-UA-Compatible" content="IE=9">
   7 | <meta http-equiv="cache-control" content="no-cache">
   8 | <meta http-equiv="pragma" content="no-cache">
   9 | <meta http-equiv="expires" content="0">
  10 | <meta name="Author" content="Jørgen Mangor Iversen">
  11 | <style>
  12 |           html          { margin: 1em 1em 1em 1em; }
  13 |           *             { font-family: Helvetica, Arial, sans-serif !important; }
  14 |           h1, h2, h3, p { text-align: center; }
  15 |           table         { solid DarkGrey; border-spacing: 0; border-collapse: collapse; page-break-inside: auto; }
  16 |           tr            { page-break-inside:avoid; page-break-after:auto; }
  17 |           th, td        { border: 1px solid DarkGrey; }
  18 |           a:link        { color: black; background-color: transparent; text-decoration: none; }
  19 |           a:visited     { color: black; background-color: transparent; text-decoration: none; }
  20 |           a:hover       { color: blue;  background-color: transparent; text-decoration: underline; }
  21 |           .nohover      { pointer-events: none; }
  22 |           @media print  { .noprint { display: none; } thead {display: table-header-group; } }
  23 |           .noprint      { position: fixed; bottom: 0.5em; right: 0.5em; z-index: 99; }
  24 |           .rotate span  { writing-mode: vertical-rl; transform: rotate(180deg); }
  25 |           .noborder     { border: none; }
  26 |           .center       { margin-left: auto; margin-right: auto; }
  27 |           .matrix       { text-align: center; }
  28 |           .check        { color: DarkGreen; }
  29 |           .hidden       { visibility: hidden; display: none; }
  30 |           .maintable    { border: 1px; width: 100%; }
  31 |           .crfhead      { background-color: Gainsboro; }
  32 |           .left         { text-align: left; }
  33 |           .formtitle    { font-style: bold;   font-weight: bold;   font-size: 1.2em; }
  34 |           .note         { font-style: italic; font-weight: normal; font-size: 0.8em; }
  35 |           .plain        { font-weight: normal; }
  36 |           .small        { font-size: 0.7em; vertical-align: midddle;}
  37 |           .inpw         { width: 40%; }
  38 |           .maxw         { width: 100%; }
  39 |           .seqw         { width: 5em !important; }
  40 |           .cdash        { background-color: lightblue; padding: 2px; color: Blue; border: 2px double Blue !important; }
  41 |           
  42 |               .anno     { visibility: hidden; display: none; }
  43 |               .quew     { width:  50%; }
  44 |               .answ     { width:  45%; }
  45 |               .desw     { width: 100%; }
  46 |             </style>
  47 | </head>
  48 | <body>
  49 | <table class="noprint"><tr><td class="noborder"><button onClick="document.documentElement.scrollTop = 0">
  50 |             Scroll to the top
  51 |           </button></td></tr></table>
  52 | <h1>Study</h1>
  53 | <h1>CRF Specification for Test Trial</h1>
  54 | <p>Selection of CRF forms available at CDISC</p>
  55 | <h2>Protocol Name: </h2>
  56 | <p>
  57 |         Creation date: 2022-07-07
  58 |         time: 10:54:53</p>
  59 | <h3>My Company</h3>
  60 | <p><img src="data:image/png;base64,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"></p>
  61 | <p style="page-break-before: always; margin-top: 0;"></p>
  62 | <table class="center">
  63 | <thead>
  64 | <tr><td class="noborder" colspan="99"><h2 class="center">Visit Matrix</h2></td></tr>
  65 | <tr>
  66 | <th class="left crfhead">Event/<br>Form</th>
  67 | <th class="crfhead rotate"><span>Screening</span></th>
  68 | <th class="crfhead rotate"><span>Visit 1</span></th>
  69 | <th class="crfhead rotate"><span>Death</span></th>
  70 | </tr>
  71 | </thead>
  72 | <tbody>
  73 | <tr>
  74 | <td><a href="#f.ie"><span>Subject eligibility</span></a></td>
  75 | <td class="matrix check">✔</td>
  76 | <td class="matrix check"></td>
  77 | <td class="matrix check"></td>
  78 | </tr>
  79 | <tr>
  80 | <td><a href="#F.0005"><span>Demographics</span></a></td>
  81 | <td class="matrix check">✔</td>
  82 | <td class="matrix check"></td>
  83 | <td class="matrix check"></td>
  84 | </tr>
  85 | <tr>
  86 | <td><a href="#F.0001"><span>Background Heart Failure Maintenance Medications Part 1</span></a></td>
  87 | <td class="matrix check">✔</td>
  88 | <td class="matrix check"></td>
  89 | <td class="matrix check"></td>
  90 | </tr>
  91 | <tr>
  92 | <td><a href="#F.0002"><span>Background Heart Failure Maintenance Medications Part 2</span></a></td>
  93 | <td class="matrix check">✔</td>
  94 | <td class="matrix check"></td>
  95 | <td class="matrix check"></td>
  96 | </tr>
  97 | <tr>
  98 | <td><a href="#F.0004"><span>Prior Psoriasis Treatments</span></a></td>
  99 | <td class="matrix check">✔</td>
 100 | <td class="matrix check"></td>
 101 | <td class="matrix check"></td>
 102 | </tr>
 103 | <tr>
 104 | <td><a href="#F.0003"><span>Body Sites of Psoriasis Involvement at Baseline</span></a></td>
 105 | <td class="matrix check">✔</td>
 106 | <td class="matrix check"></td>
 107 | <td class="matrix check"></td>
 108 | </tr>
 109 | <tr>
 110 | <td><a href="#F.0007"><span>Adverse Events</span></a></td>
 111 | <td class="matrix check"></td>
 112 | <td class="matrix check">✔</td>
 113 | <td class="matrix check">✔</td>
 114 | </tr>
 115 | <tr>
 116 | <td><a href="#F.0006"><span>ECG Test Results</span></a></td>
 117 | <td class="matrix check"></td>
 118 | <td class="matrix check">✔</td>
 119 | <td class="matrix check"></td>
 120 | </tr>
 121 | <tr>
 122 | <td><a href="#F.0000"><span>Death</span></a></td>
 123 | <td class="matrix check"></td>
 124 | <td class="matrix check"></td>
 125 | <td class="matrix check">✔</td>
 126 | </tr>
 127 | </tbody>
 128 | </table>
 129 | <p style="page-break-before: always; margin-top: 0;"></p>
 130 | <table class="center maxw">
 131 | <thead><tr><td class="noborder" colspan="3"><h2 class="center">Table of Contents</h2></td></tr></thead>
 132 | <tbody>
 133 | <tr><td colspan="3" class="noborder matrix">
 134 | <a href="#F.0007"><span>Adverse Events</span></a><p></p>
 135 | </td></tr>
 136 | <tr><td colspan="3" class="noborder matrix">
 137 | <a href="#F.0001"><span>Background Heart Failure Maintenance Medications Part 1</span></a><p></p>
 138 | </td></tr>
 139 | <tr><td colspan="3" class="noborder matrix">
 140 | <a href="#F.0002"><span>Background Heart Failure Maintenance Medications Part 2</span></a><p></p>
 141 | </td></tr>
 142 | <tr><td colspan="3" class="noborder matrix">
 143 | <a href="#F.0003"><span>Body Sites of Psoriasis Involvement at Baseline</span></a><p></p>
 144 | </td></tr>
 145 | <tr><td colspan="3" class="noborder matrix">
 146 | <a href="#F.0000"><span>Death</span></a><p></p>
 147 | </td></tr>
 148 | <tr><td colspan="3" class="noborder matrix">
 149 | <a href="#F.0005"><span>Demographics</span></a><p></p>
 150 | </td></tr>
 151 | <tr><td colspan="3" class="noborder matrix">
 152 | <a href="#F.0006"><span>ECG Test Results</span></a><p></p>
 153 | </td></tr>
 154 | <tr><td colspan="3" class="noborder matrix">
 155 | <a href="#F.0004"><span>Prior Psoriasis Treatments</span></a><p></p>
 156 | </td></tr>
 157 | <tr><td colspan="3" class="noborder matrix">
 158 | <a href="#f.ie"><span>Subject eligibility</span></a><p></p>
 159 | </td></tr>
 160 | </tbody>
 161 | </table>
 162 | <table class="maintable">
 163 | <p style="page-break-before: always;"></p>
 164 | <thead>
 165 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="f.ie"><span>Subject eligibility</span></a></div></th></tr>
 166 | <tr><th colspan="4" class="noborder"><br></th></tr>
 167 | <tr>
 168 | <th class="crfhead seqw left">Ref</th>
 169 | <th class="crfhead quew">CRF Question</th>
 170 | <th class="crfhead answ">Data Collected</th>
 171 | </tr>
 172 | </thead>
 173 | <tbody>
 174 | <tr>
 175 | <td class="seqw">1.1</td>
 176 | <td class="quew">Does the subject meet all inclusion criteria and none of the exclusion criteria?</td>
 177 | <td class="answ">
 178 | <input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br><input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br>
 179 | </td>
 180 | <td id="anno" class="annw anno">
 181 | <a href="#SUPPIE.QVAL"></a><a class="nohover" id="SUPPIE.QVAL"></a>SUPPIE.QVAL,<br><a href="#SUPPDM"></a><a class="nohover" id="SUPPDM"></a><a href="#QNAM"></a><a class="nohover" id="QNAM"></a><a href="#IEYN"></a><a class="nohover" id="IEYN"></a><a href="#SUPPDM"></a><a class="nohover" id="SUPPDM"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#All"></a><a class="nohover" id="All"></a><a href="#inclusion/exclusion"></a><a class="nohover" id="inclusion/exclusion"></a><a href="#criteria"></a><a class="nohover" id="criteria"></a><a href="#met"></a><a class="nohover" id="met"></a><a href="#SUPPDM.QLABEL"></a><a class="nohover" id="SUPPDM.QLABEL"></a><a href="#SUPPDM.QNAM"></a><a class="nohover" id="SUPPDM.QNAM"></a>SUPPDM.QNAM=IEYN, SUPPDM.QLABEL='All inclusion/exclusion criteria met'</td>
 182 | </tr>
 183 | <tr>
 184 | <td class="seqw">2.1</td>
 185 | <td class="quew">Seq. no.</td>
 186 | <td class="answ">
 187 | <input type="number"><span class="note"> Integer</span>
 188 | </td>
 189 | <td id="anno" class="annw anno">
 190 | <a href="#IE.IESPID"></a><a class="nohover" id="IE.IESPID"></a>IE.IESPID</td>
 191 | </tr>
 192 | <tr>
 193 | <td class="seqw">2.2</td>
 194 | <td class="quew">Inclusion criteria not met<p class="note left">Tick all that apply</p>
 195 | </td>
 196 | <td class="answ">
 197 | <input type="checkbox" name="$check"><label for="$check">Inclusion 1<span class="note"> (INCL01)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 2<span class="note"> (INCL02)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 3<span class="note"> (INCL03)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 4<span class="note"> (INCL04)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 5<span class="note"> (INCL05)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 6<span class="note"> (INCL06)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 7<span class="note"> (INCL07)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 8<span class="note"> (INCL08)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 9<span class="note"> (INCL09)</span></label><br><input type="checkbox" name="$check"><label for="$check">Inclusion 10<span class="note"> (INCL10)</span></label><br>
 198 | </td>
 199 | <td id="anno" class="annw anno">
 200 | <a href="#IE.IETESTCD"></a><a class="nohover" id="IE.IETESTCD"></a>IE.IETESTCD,<br><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IETEST"></a><a class="nohover" id="IETEST"></a><a href="#TI"></a><a class="nohover" id="TI"></a><a href="#IETEST"></a><a class="nohover" id="IETEST"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IECAT"></a><a class="nohover" id="IECAT"></a><a href="#TI"></a><a class="nohover" id="TI"></a><a href="#IECAT"></a><a class="nohover" id="IECAT"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#failed"></a><a class="nohover" id="failed"></a><a href="#inclusion"></a><a class="nohover" id="inclusion"></a><a href="#criteria"></a><a class="nohover" id="criteria"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IEORRES"></a><a class="nohover" id="IEORRES"></a><a href="#N"></a><a class="nohover" id="N"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IESTRESC"></a><a class="nohover" id="IESTRESC"></a><a href="#N"></a><a class="nohover" id="N"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#failed"></a><a class="nohover" id="failed"></a><a href="#exclusion"></a><a class="nohover" id="exclusion"></a><a href="#criteria"></a><a class="nohover" id="criteria"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IEORRES"></a><a class="nohover" id="IEORRES"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IESTRESC"></a><a class="nohover" id="IESTRESC"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#IE.IECAT"></a><a class="nohover" id="IE.IECAT"></a><a href="#TI.IECAT"></a><a class="nohover" id="TI.IECAT"></a><a href="#IE.IETEST"></a><a class="nohover" id="IE.IETEST"></a>IE.IETEST=TI.IETEST, IE.IECAT=TI.IECAT.
 201 |         <br><a href="#IE.IESTRESC"></a><a class="nohover" id="IE.IESTRESC"></a><a href="#IE.IEORRES"></a><a class="nohover" id="IE.IEORRES"></a>If failed inclusion criteria, IE.IEORRES=N, IE.IESTRESC=N.
 202 |         <br><a href="#IE.IESTRESC"></a><a class="nohover" id="IE.IESTRESC"></a><a href="#IE.IEORRES"></a><a class="nohover" id="IE.IEORRES"></a>If failed exclusion criteria, IE.IEORRES=Y, IE.IESTRESC=Y</td>
 203 | </tr>
 204 | <tr>
 205 | <td class="seqw">3.1</td>
 206 | <td class="quew">Seq. no.</td>
 207 | <td class="answ">
 208 | <input type="number"><span class="note"> Integer</span>
 209 | </td>
 210 | <td id="anno" class="annw anno">
 211 | <a href="#IE.IESPID"></a><a class="nohover" id="IE.IESPID"></a>IE.IESPID</td>
 212 | </tr>
 213 | <tr>
 214 | <td class="seqw">3.2</td>
 215 | <td class="quew">Exclusion criteria met<p class="note left">Tick all that apply</p>
 216 | </td>
 217 | <td class="answ">
 218 | <input type="checkbox" name="$check"><label for="$check">Exclusion 1<span class="note"> (EXCL01)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 2<span class="note"> (EXCL02)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 3<span class="note"> (EXCL03)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 4<span class="note"> (EXCL04)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 5<span class="note"> (EXCL05)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 6<span class="note"> (EXCL06)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 7<span class="note"> (EXCL07)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 8<span class="note"> (EXCL08)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 9<span class="note"> (EXCL09)</span></label><br><input type="checkbox" name="$check"><label for="$check">Exclusion 10<span class="note"> (EXCL10)</span></label><br>
 219 | </td>
 220 | <td id="anno" class="annw anno">
 221 | <a href="#IE.IETESTCD"></a><a class="nohover" id="IE.IETESTCD"></a>IE.IETESTCD,<br><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IETEST"></a><a class="nohover" id="IETEST"></a><a href="#TI"></a><a class="nohover" id="TI"></a><a href="#IETEST"></a><a class="nohover" id="IETEST"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IECAT"></a><a class="nohover" id="IECAT"></a><a href="#TI"></a><a class="nohover" id="TI"></a><a href="#IECAT"></a><a class="nohover" id="IECAT"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#failed"></a><a class="nohover" id="failed"></a><a href="#inclusion"></a><a class="nohover" id="inclusion"></a><a href="#criteria"></a><a class="nohover" id="criteria"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IEORRES"></a><a class="nohover" id="IEORRES"></a><a href="#N"></a><a class="nohover" id="N"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IESTRESC"></a><a class="nohover" id="IESTRESC"></a><a href="#N"></a><a class="nohover" id="N"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#failed"></a><a class="nohover" id="failed"></a><a href="#exclusion"></a><a class="nohover" id="exclusion"></a><a href="#criteria"></a><a class="nohover" id="criteria"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IEORRES"></a><a class="nohover" id="IEORRES"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#IE"></a><a class="nohover" id="IE"></a><a href="#IESTRESC"></a><a class="nohover" id="IESTRESC"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#IE.IECAT"></a><a class="nohover" id="IE.IECAT"></a><a href="#TI.IECAT"></a><a class="nohover" id="TI.IECAT"></a><a href="#IE.IETEST"></a><a class="nohover" id="IE.IETEST"></a>IE.IETEST= TI.IETEST, IE.IECAT=TI.IECAT.
 222 |         <br><a href="#IE.IESTRESC"></a><a class="nohover" id="IE.IESTRESC"></a><a href="#IE.IEORRES"></a><a class="nohover" id="IE.IEORRES"></a>If failed inclusion criteria, IE.IEORRES=N, IE.IESTRESC=N.
 223 |         <br><a href="#IE.IESTRESC"></a><a class="nohover" id="IE.IESTRESC"></a><a href="#IE.IEORRES"></a><a class="nohover" id="IE.IEORRES"></a>If failed exclusion criteria, IE.IEORRES=Y, IE.IESTRESC=Y</td>
 224 | </tr>
 225 | </tbody>
 226 | </table>
 227 | <table class="maintable">
 228 | <p style="page-break-before: always;"></p>
 229 | <thead>
 230 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0005"><span>Demographics</span></a></div></th></tr>
 231 | <tr><th colspan="4" class="noborder"><br></th></tr>
 232 | <tr>
 233 | <th class="crfhead seqw left">Ref</th>
 234 | <th class="crfhead quew">CRF Question</th>
 235 | <th class="crfhead answ">Data Collected</th>
 236 | </tr>
 237 | </thead>
 238 | <tbody>
 239 | <tr>
 240 | <td class="seqw">1.1</td>
 241 | <td class="quew">Birth Date</td>
 242 | <td class="answ">
 243 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 244 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 245 |         </p>
 246 | </td>
 247 | <td id="anno" class="annw anno">
 248 | <a href="#DM.BRTHDTC"></a><a class="nohover" id="DM.BRTHDTC"></a>DM.BRTHDTC,<br><a href="#Partial"></a><a class="nohover" id="Partial"></a><a href="#dates"></a><a class="nohover" id="dates"></a><a href="#are"></a><a class="nohover" id="are"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#be"></a><a class="nohover" id="be"></a><a href="#recorded"></a><a class="nohover" id="recorded"></a><a href="#according"></a><a class="nohover" id="according"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#ISO"></a><a class="nohover" id="ISO"></a><a href="#8601"></a><a class="nohover" id="8601"></a>Partial dates are to be recorded according to ISO 8601</td>
 249 | </tr>
 250 | <tr>
 251 | <td class="seqw">1.2</td>
 252 | <td class="quew">Sex</td>
 253 | <td class="answ">
 254 | <input type="radio" name="$radio"><label for="$radio">Female<span class="note"> (F)</span></label><br><input type="radio" name="$radio"><label for="$radio">Male<span class="note"> (M)</span></label><br><input type="radio" name="$radio"><label for="$radio">U; UNK; Unknown<span class="note"> (U)</span></label><br><input type="radio" name="$radio"><label for="$radio">UNDIFFERENTIATED<span class="note"> (UNDIFFERENTIATED)</span></label><br>
 255 | </td>
 256 | <td id="anno" class="annw anno">
 257 | <a href="#DM.SEX"></a><a class="nohover" id="DM.SEX"></a>DM.SEX</td>
 258 | </tr>
 259 | <tr>
 260 | <td class="seqw">1.3</td>
 261 | <td class="quew">Ethnicity</td>
 262 | <td class="answ">
 263 | <input type="radio" name="$radio"><label for="$radio">HISPANIC OR LATINO<span class="note"> (HISPANIC OR LATINO)</span></label><br><input type="radio" name="$radio"><label for="$radio">NOT HISPANIC OR LATINO<span class="note"> (NOT HISPANIC OR LATINO)</span></label><br><input type="radio" name="$radio"><label for="$radio">Not reported<span class="note"> (NOT REPORTED)</span></label><br><input type="radio" name="$radio"><label for="$radio">U; UNK; Unknown<span class="note"> (UNKNOWN)</span></label><br>
 264 | </td>
 265 | <td id="anno" class="annw anno">
 266 | <a href="#DM.ETHNIC"></a><a class="nohover" id="DM.ETHNIC"></a>DM.ETHNIC</td>
 267 | </tr>
 268 | <tr>
 269 | <td class="seqw">1.4</td>
 270 | <td class="quew">Race</td>
 271 | <td class="answ">
 272 | <input type="radio" name="$radio"><label for="$radio">AMERICAN INDIAN OR ALASKA NATIVE</label><br><input type="radio" name="$radio"><label for="$radio">ASIAN</label><br><input type="radio" name="$radio"><label for="$radio">BLACK OR AFRICAN AMERICAN</label><br><input type="radio" name="$radio"><label for="$radio">NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER</label><br><input type="radio" name="$radio"><label for="$radio">NOT REPORTED</label><br><input type="radio" name="$radio"><label for="$radio">UNKNOWN</label><br><input type="radio" name="$radio"><label for="$radio">WHITE</label><br>
 273 | </td>
 274 | <td id="anno" class="annw anno">
 275 | <a href="#DM.RACE"></a><a class="nohover" id="DM.RACE"></a>DM.RACE</td>
 276 | </tr>
 277 | </tbody>
 278 | </table>
 279 | <table class="maintable">
 280 | <p style="page-break-before: always;"></p>
 281 | <thead>
 282 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0001"><span>Background Heart Failure Maintenance Medications Part 1</span></a></div></th></tr>
 283 | <tr><th colspan="4" class="noborder"><div class="left note">Indicate whether the listed class/type of background heart failure medication was prescribed to the subject (see the study protocol for details)</div></th></tr>
 284 | <tr><th colspan="4" class="noborder"><br></th></tr>
 285 | <tr>
 286 | <th class="crfhead seqw left">Ref</th>
 287 | <th class="crfhead quew">CRF Question</th>
 288 | <th class="crfhead answ">Data Collected</th>
 289 | </tr>
 290 | </thead>
 291 | <tbody>
 292 | <tr>
 293 | <td class="seqw">1.1</td>
 294 | <td class="quew">Were any angiotensin-converting enzyme (ACE) inhibitors taken?</td>
 295 | <td class="answ">
 296 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 297 | </td>
 298 | <td id="anno" class="annw anno">
 299 | <a href="#CM.CMOCCUR"></a><a class="nohover" id="CM.CMOCCUR"></a>CM.CMOCCUR,<br><a href="#CM"></a><a class="nohover" id="CM"></a><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CM"></a><a class="nohover" id="CM"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CM"></a><a class="nohover" id="CM"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#ARBs"></a><a class="nohover" id="ARBs"></a><a href="#CM.CMTRT"></a><a class="nohover" id="CM.CMTRT"></a><a href="#CM.CMPRESP"></a><a class="nohover" id="CM.CMPRESP"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='Heart Failure Maintenance Medication', CM.CMPRESP='Y', CM.CMTRT='ARBs'</td>
 300 | </tr>
 301 | <tr>
 302 | <td class="seqw">1.2</td>
 303 | <td class="quew">If No, provide reason for not prescribing ARBs</td>
 304 | <td class="answ">
 305 | <input type="radio" name="$radio"><label for="$radio">Contraindication<span class="note"> (CONTRAINDICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">Treatment not indicated<span class="note"> (TREATMENT NOT INDICATED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Cost<span class="note"> (COST)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown<span class="note"> (UNKNOWN)</span></label><br>
 306 | </td>
 307 | <td id="anno" class="annw anno">
 308 | <a href="#CM.CMREASND"></a><a class="nohover" id="CM.CMREASND"></a>CM.CMREASND,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#ARBs"></a><a class="nohover" id="ARBs"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARBs'</td>
 309 | </tr>
 310 | <tr>
 311 | <td class="seqw">1.3</td>
 312 | <td class="quew">Were any angiotensin receptor/neprilysin inhibitors (ARNIs) taken?</td>
 313 | <td class="answ">
 314 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 315 | </td>
 316 | <td id="anno" class="annw anno">
 317 | <a href="#CM.CMOCCUR"></a><a class="nohover" id="CM.CMOCCUR"></a>CM.CMOCCUR,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#ARNIs"></a><a class="nohover" id="ARNIs"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'</td>
 318 | </tr>
 319 | <tr>
 320 | <td class="seqw">1.4</td>
 321 | <td class="quew">If No, provide reason for not prescribing ARNIs</td>
 322 | <td class="answ">
 323 | <input type="radio" name="$radio"><label for="$radio">Contraindication<span class="note"> (CONTRAINDICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">Treatment not indicated<span class="note"> (TREATMENT NOT INDICATED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Cost<span class="note"> (COST)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown<span class="note"> (UNKNOWN)</span></label><br><input type="radio" name="$radio"><label for="$radio">Cost 2<span class="note"> (COST2)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown 2<span class="note"> (UNKNOWN2)</span></label><br>
 324 | </td>
 325 | <td id="anno" class="annw anno">
 326 | <a href="#CM.CMREASND"></a><a class="nohover" id="CM.CMREASND"></a>CM.CMREASND,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#ARNIs"></a><a class="nohover" id="ARNIs"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'</td>
 327 | </tr>
 328 | <tr>
 329 | <td class="seqw">1.5</td>
 330 | <td class="quew">Were any aldosterone antagonists taken?</td>
 331 | <td class="answ">
 332 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 333 | </td>
 334 | <td id="anno" class="annw anno">
 335 | <a href="#CM.CMOCCUR"></a><a class="nohover" id="CM.CMOCCUR"></a>CM.CMOCCUR,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#Aldosterone"></a><a class="nohover" id="Aldosterone"></a><a href="#Antagonists"></a><a class="nohover" id="Antagonists"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Aldosterone Antagonists'</td>
 336 | </tr>
 337 | <tr>
 338 | <td class="seqw">1.6</td>
 339 | <td class="quew">If No, provide reason for not prescribing aldosterone antagonists</td>
 340 | <td class="answ">
 341 | <input type="radio" name="$radio"><label for="$radio">Contraindication<span class="note"> (CONTRAINDICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">Treatment not indicated<span class="note"> (TREATMENT NOT INDICATED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Cost<span class="note"> (COST)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown<span class="note"> (UNKNOWN)</span></label><br>
 342 | </td>
 343 | <td id="anno" class="annw anno">
 344 | <a href="#CM.CMREASND"></a><a class="nohover" id="CM.CMREASND"></a>CM.CMREASND,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#Aldosterone"></a><a class="nohover" id="Aldosterone"></a><a href="#Antagonists"></a><a class="nohover" id="Antagonists"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Aldosterone Antagonists'</td>
 345 | </tr>
 346 | <tr>
 347 | <td class="seqw">1.7</td>
 348 | <td class="quew">Was any hydralazine taken?</td>
 349 | <td class="answ">
 350 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 351 | </td>
 352 | <td id="anno" class="annw anno">
 353 | <a href="#CM.CMOCCUR"></a><a class="nohover" id="CM.CMOCCUR"></a>CM.CMOCCUR,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#Hydralazine"></a><a class="nohover" id="Hydralazine"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Hydralazine'</td>
 354 | </tr>
 355 | <tr>
 356 | <td class="seqw">1.8</td>
 357 | <td class="quew">If No, provide reason for not prescribing hydralazine</td>
 358 | <td class="answ">
 359 | <input type="radio" name="$radio"><label for="$radio">Contraindication<span class="note"> (CONTRAINDICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">Treatment not indicated<span class="note"> (TREATMENT NOT INDICATED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Cost<span class="note"> (COST)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown<span class="note"> (UNKNOWN)</span></label><br>
 360 | </td>
 361 | <td id="anno" class="annw anno">
 362 | <a href="#CM.CMREASND"></a><a class="nohover" id="CM.CMREASND"></a>CM.CMREASND,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#Hydralazine"></a><a class="nohover" id="Hydralazine"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Hydralazine'</td>
 363 | </tr>
 364 | <tr>
 365 | <td class="seqw">1.9</td>
 366 | <td class="quew">Were any diuretics taken?</td>
 367 | <td class="answ">
 368 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 369 | </td>
 370 | <td id="anno" class="annw anno">
 371 | <a href="#CM.CMOCCUR"></a><a class="nohover" id="CM.CMOCCUR"></a>CM.CMOCCUR,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#Diuretics"></a><a class="nohover" id="Diuretics"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Diuretics'</td>
 372 | </tr>
 373 | <tr>
 374 | <td class="seqw">1.10</td>
 375 | <td class="quew">If No, provide reason for not prescribing diuretics</td>
 376 | <td class="answ">
 377 | <input type="radio" name="$radio"><label for="$radio">Contraindication<span class="note"> (CONTRAINDICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">Treatment not indicated<span class="note"> (TREATMENT NOT INDICATED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Cost<span class="note"> (COST)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown<span class="note"> (UNKNOWN)</span></label><br>
 378 | </td>
 379 | <td id="anno" class="annw anno">
 380 | <a href="#CM.CMREASND"></a><a class="nohover" id="CM.CMREASND"></a>CM.CMREASND,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#Heart"></a><a class="nohover" id="Heart"></a><a href="#Failure"></a><a class="nohover" id="Failure"></a><a href="#Maintenance"></a><a class="nohover" id="Maintenance"></a><a href="#Medication"></a><a class="nohover" id="Medication"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#Diuretics"></a><a class="nohover" id="Diuretics"></a>CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Diuretics'</td>
 381 | </tr>
 382 | </tbody>
 383 | </table>
 384 | <table class="maintable">
 385 | <p style="page-break-before: always;"></p>
 386 | <thead>
 387 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0002"><span>Background Heart Failure Maintenance Medications Part 2</span></a></div></th></tr>
 388 | <tr><th colspan="4" class="noborder"><div class="left note">List the specific background heart failure medications used. Include all heart failure medications that are to be continued. When a subject has frequent changes in the dose and schedule for oral diuretics, the dosing information can be recorded as PRN</div></th></tr>
 389 | <tr><th colspan="4" class="noborder"><br></th></tr>
 390 | <tr>
 391 | <th class="crfhead seqw left">Ref</th>
 392 | <th class="crfhead quew">CRF Question</th>
 393 | <th class="crfhead answ">Data Collected</th>
 394 | </tr>
 395 | </thead>
 396 | <tbody>
 397 | <tr>
 398 | <td class="seqw">1.1</td>
 399 | <td class="quew">What was the medication name?</td>
 400 | <td class="answ">
 401 | <input type="text"><span class="note"> Text</span>
 402 | </td>
 403 | <td id="anno" class="annw anno">
 404 | <a href="#CM.CMTRT"></a><a class="nohover" id="CM.CMTRT"></a>CM.CMTRT</td>
 405 | </tr>
 406 | <tr>
 407 | <td class="seqw">1.2</td>
 408 | <td class="quew">What was the individual dose of the medication per administration?</td>
 409 | <td class="answ">
 410 | <input type="number"><span class="note"> Integer</span>
 411 | </td>
 412 | <td id="anno" class="annw anno">
 413 | <a href="#CM.CMDOSE"></a><a class="nohover" id="CM.CMDOSE"></a>CM.CMDOSE</td>
 414 | </tr>
 415 | <tr>
 416 | <td class="seqw">1.3</td>
 417 | <td class="quew">What is the unit of the medication per administration?</td>
 418 | <td class="answ">
 419 | <input type="radio" name="$radio"><label for="$radio">mcg<span class="note"> (ug)</span></label><br><input type="radio" name="$radio"><label for="$radio">mg<span class="note"> (mg)</span></label><br><input type="radio" name="$radio"><label for="$radio">g<span class="note"> (g)</span></label><br><input type="radio" name="$radio"><label for="$radio">Ml<span class="note"> (mL)</span></label><br><input type="radio" name="$radio"><label for="$radio">Application<span class="note"> (APPLICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">International Unit (IU)<span class="note"> (IU)</span></label><br><input type="radio" name="$radio"><label for="$radio">Tablet<span class="note"> (TABLET)</span></label><br><input type="radio" name="$radio"><label for="$radio">Capsule<span class="note"> (CAPSULE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Other<span class="note"> (OTHER)</span></label><br>
 420 | </td>
 421 | <td id="anno" class="annw anno">
 422 | <a href="#CM.CMDOSU"></a><a class="nohover" id="CM.CMDOSU"></a>CM.CMDOSU,<br><a href="#CM.CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CM.CMCAT='ANTIPSORIATIC'"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='ANTIPSORIATIC'</td>
 423 | </tr>
 424 | <tr>
 425 | <td class="seqw">1.4</td>
 426 | <td class="quew">What was the frequency of the medication?</td>
 427 | <td class="answ">
 428 | <input type="radio" name="$radio"><label for="$radio">BD; Twice per day<span class="note"> (BID)</span></label><br><input type="radio" name="$radio"><label for="$radio">As needed<span class="note"> (PRN)</span></label><br>
 429 | </td>
 430 | <td id="anno" class="annw anno">
 431 | <a href="#CM.CMDOSFRQ"></a><a class="nohover" id="CM.CMDOSFRQ"></a>CM.CMDOSFRQ</td>
 432 | </tr>
 433 | <tr>
 434 | <td class="seqw">1.5</td>
 435 | <td class="quew">What was the route of administration of the medication?</td>
 436 | <td class="answ">
 437 | <input type="radio" name="$radio"><label for="$radio">ORAL</label><br><input type="radio" name="$radio"><label for="$radio">SUBCUTANEOUS</label><br><input type="radio" name="$radio"><label for="$radio">TOPICAL</label><br><input type="radio" name="$radio"><label for="$radio">TRANSDERMAL</label><br>
 438 | </td>
 439 | <td id="anno" class="annw anno">
 440 | <a href="#CM.CMROUTE"></a><a class="nohover" id="CM.CMROUTE"></a>CM.CMROUTE,<br><a href="#CM.CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CM.CMCAT='ANTIPSORIATIC'"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='ANTIPSORIATIC'</td>
 441 | </tr>
 442 | <tr>
 443 | <td class="seqw">1.6</td>
 444 | <td class="quew">Start Date</td>
 445 | <td class="answ">
 446 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 447 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 448 |         </p>
 449 | </td>
 450 | <td id="anno" class="annw anno">
 451 | <a href="#CM.CMSTDTC"></a><a class="nohover" id="CM.CMSTDTC"></a>CM.CMSTDTC</td>
 452 | </tr>
 453 | <tr>
 454 | <td class="seqw">1.7</td>
 455 | <td class="quew">Is the medication ongoing?</td>
 456 | <td class="answ">
 457 | <input type="radio" name="$radio"><label for="$radio">AFTER</label><br><input type="radio" name="$radio"><label for="$radio">BEFORE</label><br><input type="radio" name="$radio"><label for="$radio">COINCIDENT</label><br><input type="radio" name="$radio"><label for="$radio">DURING</label><br><input type="radio" name="$radio"><label for="$radio">DURING/AFTER</label><br><input type="radio" name="$radio"><label for="$radio">ONGOING</label><br><input type="radio" name="$radio"><label for="$radio">UNKNOWN</label><br>
 458 | </td>
 459 | <td id="anno" class="annw anno">
 460 | <a href="#CM.CMENRTPT"></a><a class="nohover" id="CM.CMENRTPT"></a>CM.CMENRTPT</td>
 461 | </tr>
 462 | <tr>
 463 | <td class="seqw">1.8</td>
 464 | <td class="quew">End Date</td>
 465 | <td class="answ">
 466 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 467 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 468 |         </p>
 469 | </td>
 470 | <td id="anno" class="annw anno">
 471 | <a href="#CM.CMENDTC"></a><a class="nohover" id="CM.CMENDTC"></a>CM.CMENDTC,<br><a href="#CM.CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CM.CMCAT='ANTIPSORIATIC'"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='ANTIPSORIATIC'</td>
 472 | </tr>
 473 | <tr>
 474 | <td class="seqw">2.1</td>
 475 | <td class="quew">If applicable, was the medication given at the recommended regimen?</td>
 476 | <td class="answ">
 477 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 478 | </td>
 479 | <td id="anno" class="annw anno">
 480 | <a href="#SUPPCM.QVAL"></a><a class="nohover" id="SUPPCM.QVAL"></a>SUPPCM.QVAL,<br><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QNAM"></a><a class="nohover" id="QNAM"></a><a href="#CMRRGYN"></a><a class="nohover" id="CMRRGYN"></a><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#Was"></a><a class="nohover" id="Was"></a><a href="#medication"></a><a class="nohover" id="medication"></a><a href="#given"></a><a class="nohover" id="given"></a><a href="#at"></a><a class="nohover" id="at"></a><a href="#recom"></a><a class="nohover" id="recom"></a><a href="#regimen"></a><a class="nohover" id="regimen"></a><a href="#SUPPCM.QLABEL"></a><a class="nohover" id="SUPPCM.QLABEL"></a><a href="#SUPPCM.QNAM"></a><a class="nohover" id="SUPPCM.QNAM"></a>SUPPCM.QNAM='CMRRGYN', SUPPCM.QLABEL='Was medication given at recom. regimen'</td>
 481 | </tr>
 482 | <tr>
 483 | <td class="seqw">2.2</td>
 484 | <td class="quew">If applicable, why was the medication not given at the recommended regimen?</td>
 485 | <td class="answ">
 486 | <input type="text"><span class="note"> Text</span>
 487 | </td>
 488 | <td id="anno" class="annw anno">
 489 | <a href="#SUPPCM.QVAL"></a><a class="nohover" id="SUPPCM.QVAL"></a>SUPPCM.QVAL,<br><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QVAL"></a><a class="nohover" id="QVAL"></a><a href="#CMRRGREA"></a><a class="nohover" id="CMRRGREA"></a><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#Why"></a><a class="nohover" id="Why"></a><a href="#the"></a><a class="nohover" id="the"></a><a href="#medication"></a><a class="nohover" id="medication"></a><a href="#not"></a><a class="nohover" id="not"></a><a href="#given"></a><a class="nohover" id="given"></a><a href="#at"></a><a class="nohover" id="at"></a><a href="#regimen"></a><a class="nohover" id="regimen"></a><a href="#SUPPCM.QLABEL"></a><a class="nohover" id="SUPPCM.QLABEL"></a><a href="#SUPPCM.QVAL"></a><a class="nohover" id="SUPPCM.QVAL"></a>SUPPCM.QVAL='CMRRGREA', SUPPCM.QLABEL='Why the medication not given at regimen'</td>
 490 | </tr>
 491 | </tbody>
 492 | </table>
 493 | <table class="maintable">
 494 | <p style="page-break-before: always;"></p>
 495 | <thead>
 496 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0004"><span>Prior Psoriasis Treatments</span></a></div></th></tr>
 497 | <tr><th colspan="4" class="noborder"><br></th></tr>
 498 | <tr>
 499 | <th class="crfhead seqw left">Ref</th>
 500 | <th class="crfhead quew">CRF Question</th>
 501 | <th class="crfhead answ">Data Collected</th>
 502 | </tr>
 503 | </thead>
 504 | <tbody>
 505 | <tr>
 506 | <td class="seqw">1.1</td>
 507 | <td class="quew">Has the subject had any psoriasis treatments before the study start?</td>
 508 | <td class="answ">
 509 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 510 | </td>
 511 | <td id="anno" class="annw anno">
 512 | <a href="#CM.CMOCCUR"></a><a class="nohover" id="CM.CMOCCUR"></a>CM.CMOCCUR,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#ANTIPSORIATIC"></a><a class="nohover" id="ANTIPSORIATIC"></a><a href="#CMTRT"></a><a class="nohover" id="CMTRT"></a><a href="#ANTIPSORIATIC"></a><a class="nohover" id="ANTIPSORIATIC"></a><a href="#CMPRESP"></a><a class="nohover" id="CMPRESP"></a><a href="#Y"></a><a class="nohover" id="Y"></a><a href="#CMSTRF"></a><a class="nohover" id="CMSTRF"></a><a href="#BEFORE"></a><a class="nohover" id="BEFORE"></a>CMCAT='ANTIPSORIATIC', CMTRT='ANTIPSORIATIC', CMPRESP='Y', CMSTRF='BEFORE'</td>
 513 | </tr>
 514 | <tr>
 515 | <td class="seqw">1.2</td>
 516 | <td class="quew">What is the subcategory for the treatment?</td>
 517 | <td class="answ">
 518 | <input type="radio" name="$radio"><label for="$radio">Biologic<span class="note"> (BIOLOGIC)</span></label><br><input type="radio" name="$radio"><label for="$radio">Non-Biologic<span class="note"> (NON-BIOLOGIC)</span></label><br><input type="radio" name="$radio"><label for="$radio">Phototherapy<span class="note"> (PHOTOTHERAPY)</span></label><br>
 519 | </td>
 520 | <td id="anno" class="annw anno">
 521 | <a href="#CM.CMSCAT"></a><a class="nohover" id="CM.CMSCAT"></a>CM.CMSCAT,<br><a href="#CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CMCAT='ANTIPSORIATIC'"></a>CMCAT='ANTIPSORIATIC'</td>
 522 | </tr>
 523 | <tr>
 524 | <td class="seqw">1.3</td>
 525 | <td class="quew">What was the name of the treatment?</td>
 526 | <td class="answ">
 527 | <input type="text"><span class="note"> Text</span>
 528 | </td>
 529 | <td id="anno" class="annw anno">
 530 | <a href="#CM.CMTRT"></a><a class="nohover" id="CM.CMTRT"></a>CM.CMTRT,<br><a href="#CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CMCAT='ANTIPSORIATIC'"></a>CMCAT='ANTIPSORIATIC'</td>
 531 | </tr>
 532 | <tr>
 533 | <td class="seqw">1.4</td>
 534 | <td class="quew">What was the route of administration of the medication?</td>
 535 | <td class="answ">
 536 | <input type="radio" name="$radio"><label for="$radio">ORAL</label><br><input type="radio" name="$radio"><label for="$radio">SUBCUTANEOUS</label><br><input type="radio" name="$radio"><label for="$radio">TOPICAL</label><br><input type="radio" name="$radio"><label for="$radio">TRANSDERMAL</label><br>
 537 | </td>
 538 | <td id="anno" class="annw anno">
 539 | <a href="#CM.CMROUTE"></a><a class="nohover" id="CM.CMROUTE"></a>CM.CMROUTE,<br><a href="#CM.CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CM.CMCAT='ANTIPSORIATIC'"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='ANTIPSORIATIC'</td>
 540 | </tr>
 541 | <tr>
 542 | <td class="seqw">1.5</td>
 543 | <td class="quew">If the treatment was systemic, what was the individual dose?</td>
 544 | <td class="answ">
 545 | <input type="text"><span class="note"> Text</span>
 546 | </td>
 547 | <td id="anno" class="annw anno">
 548 | <a href="#CM.CMDOSTXT"></a><a class="nohover" id="CM.CMDOSTXT"></a>CM.CMDOSTXT,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#ANTIPSORIATIC"></a><a class="nohover" id="ANTIPSORIATIC"></a><a href="#CMDOSE"></a><a class="nohover" id="CMDOSE"></a><a href="#if"></a><a class="nohover" id="if"></a><a href="#all"></a><a class="nohover" id="all"></a><a href="#values"></a><a class="nohover" id="values"></a><a href="#of"></a><a class="nohover" id="of"></a><a href="#CMDOSTXT"></a><a class="nohover" id="CMDOSTXT"></a><a href="#are"></a><a class="nohover" id="are"></a><a href="#numeric"></a><a class="nohover" id="numeric"></a>CMCAT='ANTIPSORIATIC', CMDOSE if all values of CMDOSTXT are numeric</td>
 549 | </tr>
 550 | <tr>
 551 | <td class="seqw">1.6</td>
 552 | <td class="quew">What is the unit of the medication per administration?</td>
 553 | <td class="answ">
 554 | <input type="radio" name="$radio"><label for="$radio">mcg<span class="note"> (ug)</span></label><br><input type="radio" name="$radio"><label for="$radio">mg<span class="note"> (mg)</span></label><br><input type="radio" name="$radio"><label for="$radio">g<span class="note"> (g)</span></label><br><input type="radio" name="$radio"><label for="$radio">Ml<span class="note"> (mL)</span></label><br><input type="radio" name="$radio"><label for="$radio">Application<span class="note"> (APPLICATION)</span></label><br><input type="radio" name="$radio"><label for="$radio">International Unit (IU)<span class="note"> (IU)</span></label><br><input type="radio" name="$radio"><label for="$radio">Tablet<span class="note"> (TABLET)</span></label><br><input type="radio" name="$radio"><label for="$radio">Capsule<span class="note"> (CAPSULE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Other<span class="note"> (OTHER)</span></label><br>
 555 | </td>
 556 | <td id="anno" class="annw anno">
 557 | <a href="#CM.CMDOSU"></a><a class="nohover" id="CM.CMDOSU"></a>CM.CMDOSU,<br><a href="#CM.CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CM.CMCAT='ANTIPSORIATIC'"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='ANTIPSORIATIC'</td>
 558 | </tr>
 559 | <tr>
 560 | <td class="seqw">2.1</td>
 561 | <td class="quew">If the medication was a biologic, what device was used for drug administration?</td>
 562 | <td class="answ">
 563 | <input type="radio" name="$radio"><label for="$radio">Single-dose pen<span class="note"> (SINGLE-DOSE PEN)</span></label><br><input type="radio" name="$radio"><label for="$radio">Multiple-dose pen<span class="note"> (MULTIPLE-DOSE PEN)</span></label><br><input type="radio" name="$radio"><label for="$radio">Pre-filled syringe<span class="note"> (PRE-FILLED SYRINGE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Syringe<span class="note"> (SYRINGE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Not Applicable<span class="note"> (NOT APPLICABLE)</span></label><br>
 564 | </td>
 565 | <td id="anno" class="annw anno">
 566 | <a href="#SUPPCM.QVAL"></a><a class="nohover" id="SUPPCM.QVAL"></a>SUPPCM.QVAL,<br><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QNAM"></a><a class="nohover" id="QNAM"></a><a href="#SPDEVID"></a><a class="nohover" id="SPDEVID"></a><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#Device"></a><a class="nohover" id="Device"></a><a href="#Identifier"></a><a class="nohover" id="Identifier"></a><a href="#SUPPCM.QLABEL"></a><a class="nohover" id="SUPPCM.QLABEL"></a><a href="#SUPPCM.QNAM"></a><a class="nohover" id="SUPPCM.QNAM"></a>SUPPCM.QNAM='SPDEVID', SUPPCM.QLABEL='Device Identifier'</td>
 567 | </tr>
 568 | <tr>
 569 | <td class="seqw">3.1</td>
 570 | <td class="quew">Start Date</td>
 571 | <td class="answ">
 572 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 573 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 574 |         </p>
 575 | </td>
 576 | <td id="anno" class="annw anno">
 577 | <a href="#CM.CMSTDTC"></a><a class="nohover" id="CM.CMSTDTC"></a>CM.CMSTDTC,<br><a href="#CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CMCAT='ANTIPSORIATIC'"></a>CMCAT='ANTIPSORIATIC'</td>
 578 | </tr>
 579 | <tr>
 580 | <td class="seqw">3.2</td>
 581 | <td class="quew">Is the medication ongoing?</td>
 582 | <td class="answ">
 583 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 584 | </td>
 585 | <td id="anno" class="annw anno">
 586 | <a href="#CM.CMENRTPT"></a><a class="nohover" id="CM.CMENRTPT"></a>CM.CMENRTPT,<br><a href="#CMCAT"></a><a class="nohover" id="CMCAT"></a><a href="#ANTIPSORIATIC"></a><a class="nohover" id="ANTIPSORIATIC"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#Yes"></a><a class="nohover" id="Yes"></a><a href="#CMENRTPT"></a><a class="nohover" id="CMENRTPT"></a><a href="#ONGOING"></a><a class="nohover" id="ONGOING"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#No"></a><a class="nohover" id="No"></a><a href="#CMENRF"></a><a class="nohover" id="CMENRF"></a><a href="#blank"></a><a class="nohover" id="blank"></a>CMCAT='ANTIPSORIATIC', If Yes, CMENRTPT='ONGOING'.
 587 |         <br>If No, CMENRF=blank</td>
 588 | </tr>
 589 | <tr>
 590 | <td class="seqw">3.3</td>
 591 | <td class="quew">End Date</td>
 592 | <td class="answ">
 593 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 594 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 595 |         </p>
 596 | </td>
 597 | <td id="anno" class="annw anno">
 598 | <a href="#CM.CMENDTC"></a><a class="nohover" id="CM.CMENDTC"></a>CM.CMENDTC,<br><a href="#CM.CMCAT='ANTIPSORIATIC'"></a><a class="nohover" id="CM.CMCAT='ANTIPSORIATIC'"></a><a href="#CM.CMCAT"></a><a class="nohover" id="CM.CMCAT"></a>CM.CMCAT='ANTIPSORIATIC'</td>
 599 | </tr>
 600 | <tr>
 601 | <td class="seqw">4.1</td>
 602 | <td class="quew">What was the reason for treatment discontinuation?</td>
 603 | <td class="answ">
 604 | <input type="radio" name="$radio"><label for="$radio">Inadequate efficiacy<span class="note"> (INADEQUATE EFFICACY)</span></label><br><input type="radio" name="$radio"><label for="$radio">Adverse event<span class="note"> (ADVERSE EVENT)</span></label><br><input type="radio" name="$radio"><label for="$radio">Other-not related to efficacy/adverse event<span class="note"> (OTHER-NOT RELATED TO EFFICACY/ADVERSE EVENTS)</span></label><br>
 605 | </td>
 606 | <td id="anno" class="annw anno">
 607 | <a href="#SUPPCM.QVAL"></a><a class="nohover" id="SUPPCM.QVAL"></a>SUPPCM.QVAL,<br><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QNAM"></a><a class="nohover" id="QNAM"></a><a href="#CMRSDISC"></a><a class="nohover" id="CMRSDISC"></a><a href="#SUPPCM"></a><a class="nohover" id="SUPPCM"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#Reason"></a><a class="nohover" id="Reason"></a><a href="#for"></a><a class="nohover" id="for"></a><a href="#treatment"></a><a class="nohover" id="treatment"></a><a href="#discontinuation"></a><a class="nohover" id="discontinuation"></a><a href="#SUPPCM.QLABEL"></a><a class="nohover" id="SUPPCM.QLABEL"></a><a href="#SUPPCM.QNAM"></a><a class="nohover" id="SUPPCM.QNAM"></a>SUPPCM.QNAM='CMRSDISC', SUPPCM.QLABEL='Reason for treatment discontinuation'</td>
 608 | </tr>
 609 | </tbody>
 610 | </table>
 611 | <table class="maintable">
 612 | <p style="page-break-before: always;"></p>
 613 | <thead>
 614 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0003"><span>Body Sites of Psoriasis Involvement at Baseline</span></a></div></th></tr>
 615 | <tr><th colspan="4" class="noborder"><div class="left note">CRF Instructions: Use one page per affected area</div></th></tr>
 616 | <tr><th colspan="4" class="noborder"><br></th></tr>
 617 | <tr>
 618 | <th class="crfhead seqw left">Ref</th>
 619 | <th class="crfhead quew">CRF Question</th>
 620 | <th class="crfhead answ">Data Collected</th>
 621 | </tr>
 622 | </thead>
 623 | <tbody>
 624 | <tr>
 625 | <td class="seqw">1.1</td>
 626 | <td class="quew">What was the location of psoriasis lesion involvement?</td>
 627 | <td class="answ">
 628 | <input type="radio" name="$radio"><label for="$radio">FACE<span class="note"> (FACE)</span></label><br><input type="radio" name="$radio"><label for="$radio">GENITALIA<span class="note"> (GENITALIA)</span></label><br><input type="radio" name="$radio"><label for="$radio">Hand<span class="note"> (HAND)</span></label><br><input type="radio" name="$radio"><label for="$radio">HEAD<span class="note"> (HEAD)</span></label><br><input type="radio" name="$radio"><label for="$radio">Lower Extremity<span class="note"> (LIMB, LOWER)</span></label><br><input type="radio" name="$radio"><label for="$radio">Upper Extremity<span class="note"> (LIMB, UPPER)</span></label><br><input type="radio" name="$radio"><label for="$radio">SCALP<span class="note"> (SCALP)</span></label><br><input type="radio" name="$radio"><label for="$radio">Torso<span class="note"> (TRUNK)</span></label><br>
 629 | </td>
 630 | <td id="anno" class="annw anno">
 631 | <a href="#QS.QSLOC"></a><a class="nohover" id="QS.QSLOC"></a>QS.QSLOC,<br><a href="#QSTESTCD"></a><a class="nohover" id="QSTESTCD"></a><a href="#LESIDENT"></a><a class="nohover" id="LESIDENT"></a><a href="#QSTEST"></a><a class="nohover" id="QSTEST"></a><a href="#Lesion"></a><a class="nohover" id="Lesion"></a><a href="#Identification"></a><a class="nohover" id="Identification"></a>QSTESTCD='LESIDENT',QSTEST='Lesion Identification'</td>
 632 | </tr>
 633 | <tr>
 634 | <td class="seqw">1.2</td>
 635 | <td class="quew">If applicable, what was the laterality of the anatomical location?</td>
 636 | <td class="answ">
 637 | <input type="radio" name="$radio"><label for="$radio">LEFT</label><br><input type="radio" name="$radio"><label for="$radio">RIGHT</label><br><input type="radio" name="$radio"><label for="$radio">NOT APPLICABLE</label><br>
 638 | </td>
 639 | <td id="anno" class="annw anno">
 640 | <a href="#QS.QSLAT"></a><a class="nohover" id="QS.QSLAT"></a>QS.QSLAT,<br><a href="#QSTESTCD"></a><a class="nohover" id="QSTESTCD"></a><a href="#LESIDENT"></a><a class="nohover" id="LESIDENT"></a><a href="#QSTEST"></a><a class="nohover" id="QSTEST"></a><a href="#Lesion"></a><a class="nohover" id="Lesion"></a><a href="#Identification"></a><a class="nohover" id="Identification"></a>QSTESTCD='LESIDENT', QSTEST='Lesion Identification'</td>
 641 | </tr>
 642 | <tr>
 643 | <td class="seqw">1.3</td>
 644 | <td class="quew">If applicable, what was the directionality of the anatomical location?</td>
 645 | <td class="answ">
 646 | <input type="radio" name="$radio"><label for="$radio">ANTERIOR</label><br><input type="radio" name="$radio"><label for="$radio">POSTERIOR</label><br><input type="radio" name="$radio"><label for="$radio">NOT APPLICABLE</label><br>
 647 | </td>
 648 | <td id="anno" class="annw anno">
 649 | <a href="#QS.QSDIR"></a><a class="nohover" id="QS.QSDIR"></a>QS.QSDIR,<br><a href="#QSTESTCD"></a><a class="nohover" id="QSTESTCD"></a><a href="#LESIDENT"></a><a class="nohover" id="LESIDENT"></a><a href="#QSTEST"></a><a class="nohover" id="QSTEST"></a><a href="#Lesion"></a><a class="nohover" id="Lesion"></a><a href="#Identification"></a><a class="nohover" id="Identification"></a>QSTESTCD='LESIDENT', QSTEST='Lesion Identification'</td>
 650 | </tr>
 651 | </tbody>
 652 | </table>
 653 | <table class="maintable">
 654 | <p style="page-break-before: always;"></p>
 655 | <thead>
 656 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0007"><span>Adverse Events</span></a></div></th></tr>
 657 | <tr><th colspan="4" class="noborder"><br></th></tr>
 658 | <tr>
 659 | <th class="crfhead seqw left">Ref</th>
 660 | <th class="crfhead quew">CRF Question</th>
 661 | <th class="crfhead answ">Data Collected</th>
 662 | </tr>
 663 | </thead>
 664 | <tbody>
 665 | <tr>
 666 | <td class="seqw">1.1</td>
 667 | <td class="quew">Were any adverse events experienced?</td>
 668 | <td class="answ">
 669 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 670 | </td>
 671 | <td id="anno" class="annw anno">
 672 | <a href="#NOT"></a><a class="nohover" id="NOT"></a><a href="#SUBMITTED"></a><a class="nohover" id="SUBMITTED"></a>NOT SUBMITTED</td>
 673 | </tr>
 674 | <tr>
 675 | <td class="seqw">1.2</td>
 676 | <td class="quew">AE Group ID</td>
 677 | <td class="answ">
 678 | <input type="text"><span class="note"> Text</span>
 679 | </td>
 680 | <td id="anno" class="annw anno">
 681 | <a href="#AE.AEGRPID"></a><a class="nohover" id="AE.AEGRPID"></a>AE.AEGRPID</td>
 682 | </tr>
 683 | <tr>
 684 | <td class="seqw">1.3</td>
 685 | <td class="quew">What is the adverse event term?</td>
 686 | <td class="answ">
 687 | <input type="text"><span class="note"> Text</span>
 688 | </td>
 689 | <td id="anno" class="annw anno">
 690 | <a href="#AE.AETERM"></a><a class="nohover" id="AE.AETERM"></a>AE.AETERM</td>
 691 | </tr>
 692 | <tr>
 693 | <td class="seqw">2.1</td>
 694 | <td class="quew">AE Identifier</td>
 695 | <td class="answ">
 696 | <input type="number"><span class="note"> Integer</span>
 697 | </td>
 698 | <td id="anno" class="annw anno">
 699 | <a href="#AE.AESPID"></a><a class="nohover" id="AE.AESPID"></a>AE.AESPID</td>
 700 | </tr>
 701 | <tr>
 702 | <td class="seqw">2.2</td>
 703 | <td class="quew">What is the date the adverse event started?</td>
 704 | <td class="answ">
 705 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 706 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 707 |         </p>
 708 | </td>
 709 | <td id="anno" class="annw anno">
 710 | <a href="#AE.AESTDTC"></a><a class="nohover" id="AE.AESTDTC"></a>AE.AESTDTC,<br><a href="#Partial"></a><a class="nohover" id="Partial"></a><a href="#dates"></a><a class="nohover" id="dates"></a><a href="#are"></a><a class="nohover" id="are"></a><a href="#stored"></a><a class="nohover" id="stored"></a><a href="#according"></a><a class="nohover" id="according"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#ISO8601"></a><a class="nohover" id="ISO8601"></a>Partial dates are stored according to ISO8601</td>
 711 | </tr>
 712 | <tr>
 713 | <td class="seqw">2.3</td>
 714 | <td class="quew">Is the adverse event still ongoing?</td>
 715 | <td class="answ">
 716 | <input type="text"><span class="note"> Text</span>
 717 | </td>
 718 | <td id="anno" class="annw anno">
 719 | <a href="#AE.AEENTPT"></a><a class="nohover" id="AE.AEENTPT"></a>AE.AEENTPT,<br><a href="#If"></a><a class="nohover" id="If"></a><a href="#Yes"></a><a class="nohover" id="Yes"></a><a href="#AE"></a><a class="nohover" id="AE"></a><a href="#AEENTPT"></a><a class="nohover" id="AEENTPT"></a><a href="#ONGOING"></a><a class="nohover" id="ONGOING"></a><a href="#If"></a><a class="nohover" id="If"></a><a href="#No"></a><a class="nohover" id="No"></a><a href="#AE"></a><a class="nohover" id="AE"></a><a href="#AEENTPT"></a><a class="nohover" id="AEENTPT"></a><a href="#BEFORE"></a><a class="nohover" id="BEFORE"></a><a href="#AE.AEENTPT"></a><a class="nohover" id="AE.AEENTPT"></a>If Yes, AE.AEENTPT=ONGOING.
 720 |         <br><a href="#AE.AEENTPT"></a><a class="nohover" id="AE.AEENTPT"></a>If No, AE.AEENTPT=BEFORE</td>
 721 | </tr>
 722 | <tr>
 723 | <td class="seqw">2.4</td>
 724 | <td class="quew">End date</td>
 725 | <td class="answ">
 726 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 727 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 728 |         </p>
 729 | </td>
 730 | <td id="anno" class="annw anno">
 731 | <a href="#AE.AEENDTC"></a><a class="nohover" id="AE.AEENDTC"></a>AE.AEENDTC,<br><a href="#Partial"></a><a class="nohover" id="Partial"></a><a href="#dates"></a><a class="nohover" id="dates"></a><a href="#are"></a><a class="nohover" id="are"></a><a href="#stored"></a><a class="nohover" id="stored"></a><a href="#according"></a><a class="nohover" id="according"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#ISO8601"></a><a class="nohover" id="ISO8601"></a>Partial dates are stored according to ISO8601</td>
 732 | </tr>
 733 | <tr>
 734 | <td class="seqw">2.5</td>
 735 | <td class="quew">What is the toxicity grade of the adverse event?</td>
 736 | <td class="answ">
 737 | <input type="radio" name="$radio"><label for="$radio">Absent<span class="note"> (0)</span></label><br><input type="radio" name="$radio"><label for="$radio">Mild<span class="note"> (1)</span></label><br><input type="radio" name="$radio"><label for="$radio">Moderate<span class="note"> (2)</span></label><br><input type="radio" name="$radio"><label for="$radio">Severe<span class="note"> (3)</span></label><br><input type="radio" name="$radio"><label for="$radio">Life Threatening<span class="note"> (4)</span></label><br><input type="radio" name="$radio"><label for="$radio">Fatal<span class="note"> (5)</span></label><br>
 738 | </td>
 739 | <td id="anno" class="annw anno">
 740 | <a href="#AE.AETOXGR"></a><a class="nohover" id="AE.AETOXGR"></a>AE.AETOXGR</td>
 741 | </tr>
 742 | <tr>
 743 | <td class="seqw">2.6</td>
 744 | <td class="quew">Is the adverse event serious?</td>
 745 | <td class="answ">
 746 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 747 | </td>
 748 | <td id="anno" class="annw anno">
 749 | <a href="#AE.AESER"></a><a class="nohover" id="AE.AESER"></a>AE.AESER</td>
 750 | </tr>
 751 | <tr>
 752 | <td class="seqw">2.7</td>
 753 | <td class="quew">Congenital Anomaly or Birth Defect</td>
 754 | <td class="answ">
 755 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 756 | </td>
 757 | <td id="anno" class="annw anno">
 758 | <a href="#AE.AESCONG"></a><a class="nohover" id="AE.AESCONG"></a>AE.AESCONG</td>
 759 | </tr>
 760 | <tr>
 761 | <td class="seqw">2.8</td>
 762 | <td class="quew">Significant Disability</td>
 763 | <td class="answ">
 764 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 765 | </td>
 766 | <td id="anno" class="annw anno">
 767 | <a href="#AE.AESDISAB"></a><a class="nohover" id="AE.AESDISAB"></a>AE.AESDISAB</td>
 768 | </tr>
 769 | <tr>
 770 | <td class="seqw">2.9</td>
 771 | <td class="quew">Death</td>
 772 | <td class="answ">
 773 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 774 | </td>
 775 | <td id="anno" class="annw anno">
 776 | <a href="#AE.AESDTH"></a><a class="nohover" id="AE.AESDTH"></a>AE.AESDTH</td>
 777 | </tr>
 778 | <tr>
 779 | <td class="seqw">2.10</td>
 780 | <td class="quew">Hospitalization</td>
 781 | <td class="answ">
 782 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 783 | </td>
 784 | <td id="anno" class="annw anno">
 785 | <a href="#AE.AESHOSP"></a><a class="nohover" id="AE.AESHOSP"></a>AE.AESHOSP</td>
 786 | </tr>
 787 | <tr>
 788 | <td class="seqw">2.11</td>
 789 | <td class="quew">Life Threatening</td>
 790 | <td class="answ">
 791 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 792 | </td>
 793 | <td id="anno" class="annw anno">
 794 | <a href="#AE.AESLIFE"></a><a class="nohover" id="AE.AESLIFE"></a>AE.AESLIFE</td>
 795 | </tr>
 796 | <tr>
 797 | <td class="seqw">2.12</td>
 798 | <td class="quew">Occurs with Overdose</td>
 799 | <td class="answ">
 800 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 801 | </td>
 802 | <td id="anno" class="annw anno">
 803 | <a href="#AE.AESOD"></a><a class="nohover" id="AE.AESOD"></a>AE.AESOD</td>
 804 | </tr>
 805 | <tr>
 806 | <td class="seqw">2.13</td>
 807 | <td class="quew">Other Medically Important Event</td>
 808 | <td class="answ">
 809 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 810 | </td>
 811 | <td id="anno" class="annw anno">
 812 | <a href="#AE.AESMIE"></a><a class="nohover" id="AE.AESMIE"></a>AE.AESMIE</td>
 813 | </tr>
 814 | <tr>
 815 | <td class="seqw">2.14</td>
 816 | <td class="quew">Concomitant or Additional Treament Given</td>
 817 | <td class="answ">
 818 | <input type="checkbox" name="$check"><label for="$check">No<span class="note"> (N)</span></label><br><input type="checkbox" name="$check"><label for="$check">Yes<span class="note"> (Y)</span></label><br>
 819 | </td>
 820 | <td id="anno" class="annw anno">
 821 | <a href="#AE.AECONTRT"></a><a class="nohover" id="AE.AECONTRT"></a>AE.AECONTRT</td>
 822 | </tr>
 823 | <tr>
 824 | <td class="seqw">2.15</td>
 825 | <td class="quew">Is this event related to study treatment?</td>
 826 | <td class="answ">
 827 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 828 | </td>
 829 | <td id="anno" class="annw anno">
 830 | <a href="#AE.AEREL"></a><a class="nohover" id="AE.AEREL"></a>AE.AEREL</td>
 831 | </tr>
 832 | <tr>
 833 | <td class="seqw">2.16</td>
 834 | <td class="quew">Relationship to Non-Study Treatment</td>
 835 | <td class="answ">
 836 | <input type="radio" name="$radio"><label for="$radio">Adjunct Therapy<span class="note"> (ADJUNCT THERAPY)</span></label><br><input type="radio" name="$radio"><label for="$radio">Concomitant Therapy<span class="note"> (CONCOMITANT THERAPY)</span></label><br><input type="radio" name="$radio"><label for="$radio">Study Device<span class="note"> (STUDY DEVICE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Study Disease<span class="note"> (STUDY DISEASE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Study Procedure<span class="note"> (STUDY PROCEDURE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Other Medical Condition<span class="note"> (OTHER MEDICAL CONDITION)</span></label><br>
 837 | </td>
 838 | <td id="anno" class="annw anno">
 839 | <a href="#AE.AERELNST"></a><a class="nohover" id="AE.AERELNST"></a>AE.AERELNST</td>
 840 | </tr>
 841 | <tr>
 842 | <td class="seqw">2.17</td>
 843 | <td class="quew">What was the outcome of this adverse event?</td>
 844 | <td class="answ">
 845 | <input type="radio" name="$radio"><label for="$radio">Fatal<span class="note"> (FATAL)</span></label><br><input type="radio" name="$radio"><label for="$radio">Not recovered/not resolved<span class="note"> (NOT RECOVERED/NOT RESOLVED )</span></label><br><input type="radio" name="$radio"><label for="$radio">Recovered/resolved with sequelae<span class="note"> (RECOVERED/RESOLVED WITH SEQUELAE )</span></label><br><input type="radio" name="$radio"><label for="$radio">Recovered/resolved<span class="note"> (RECOVERED/RESOLVED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Recovering/resolving<span class="note"> (RECOVERING/RESOLVING )</span></label><br><input type="radio" name="$radio"><label for="$radio">Unkmown<span class="note"> (C49496)</span></label><br>
 846 | </td>
 847 | <td id="anno" class="annw anno">
 848 | <a href="#AE.AEOUT"></a><a class="nohover" id="AE.AEOUT"></a>AE.AEOUT</td>
 849 | </tr>
 850 | <tr>
 851 | <td class="seqw">2.18</td>
 852 | <td class="quew">What action was taken with study treatment?</td>
 853 | <td class="answ">
 854 | <input type="radio" name="$radio"><label for="$radio">Dose not changed<span class="note"> (DOSE NOT CHANGED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Dose reduced<span class="note"> (DOSE REDUCED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Dose increased<span class="note"> (DOSE INCREASED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Drug interrupted<span class="note"> (DRUG INTERRUPTED)</span></label><br><input type="radio" name="$radio"><label for="$radio">Drug withdrawn<span class="note"> (DRUG WITHDRAWN)</span></label><br><input type="radio" name="$radio"><label for="$radio">Not applicable<span class="note"> (NOT APPLICABLE)</span></label><br><input type="radio" name="$radio"><label for="$radio">Unknown<span class="note"> (UNKNOWN)</span></label><br>
 855 | </td>
 856 | <td id="anno" class="annw anno">
 857 | <a href="#AE.AEACN"></a><a class="nohover" id="AE.AEACN"></a>AE.AEACN</td>
 858 | </tr>
 859 | <tr>
 860 | <td class="seqw">3.1</td>
 861 | <td class="quew">Is this event a dose limiting toxicity?</td>
 862 | <td class="answ">
 863 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 864 | </td>
 865 | <td id="anno" class="annw anno">
 866 | <a href="#SUPPAE.QVAL"></a><a class="nohover" id="SUPPAE.QVAL"></a>SUPPAE.QVAL,<br><a href="#SUPPAE"></a><a class="nohover" id="SUPPAE"></a><a href="#QNAM"></a><a class="nohover" id="QNAM"></a><a href="#AEDLTOXF"></a><a class="nohover" id="AEDLTOXF"></a><a href="#SUPPAE"></a><a class="nohover" id="SUPPAE"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#Dose"></a><a class="nohover" id="Dose"></a><a href="#Limiting"></a><a class="nohover" id="Limiting"></a><a href="#Toxicity"></a><a class="nohover" id="Toxicity"></a><a href="#SUPPAE.QLABEL"></a><a class="nohover" id="SUPPAE.QLABEL"></a><a href="#SUPPAE.QNAM"></a><a class="nohover" id="SUPPAE.QNAM"></a>SUPPAE.QNAM=AEDLTOXF, SUPPAE.QLABEL='Dose Limiting Toxicity'</td>
 867 | </tr>
 868 | </tbody>
 869 | </table>
 870 | <table class="maintable">
 871 | <p style="page-break-before: always;"></p>
 872 | <thead>
 873 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0006"><span>ECG Test Results</span></a></div></th></tr>
 874 | <tr><th colspan="4" class="noborder"><br></th></tr>
 875 | <tr>
 876 | <th class="crfhead seqw left">Ref</th>
 877 | <th class="crfhead quew">CRF Question</th>
 878 | <th class="crfhead answ">Data Collected</th>
 879 | </tr>
 880 | </thead>
 881 | <tbody>
 882 | <tr>
 883 | <td class="seqw">1.1</td>
 884 | <td class="quew">Was the ECG performed?</td>
 885 | <td class="answ">
 886 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 887 | </td>
 888 | <td id="anno" class="annw anno">
 889 | <a href="#NOT"></a><a class="nohover" id="NOT"></a><a href="#SUBMITTED"></a><a class="nohover" id="SUBMITTED"></a>NOT SUBMITTED</td>
 890 | </tr>
 891 | <tr>
 892 | <td class="seqw">2.1</td>
 893 | <td class="quew">What was the ECG date?</td>
 894 | <td class="answ">
 895 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 896 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 897 |         </p>
 898 | </td>
 899 | <td id="anno" class="annw anno">
 900 | <a href="#EG.EGSTDTC"></a><a class="nohover" id="EG.EGSTDTC"></a>EG.EGSTDTC,<br><a href="#Date"></a><a class="nohover" id="Date"></a><a href="#and"></a><a class="nohover" id="and"></a><a href="#time"></a><a class="nohover" id="time"></a><a href="#are"></a><a class="nohover" id="are"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#be"></a><a class="nohover" id="be"></a><a href="#combined"></a><a class="nohover" id="combined"></a><a href="#into"></a><a class="nohover" id="into"></a><a href="#one"></a><a class="nohover" id="one"></a><a href="#variable"></a><a class="nohover" id="variable"></a><a href="#according"></a><a class="nohover" id="according"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#ISO"></a><a class="nohover" id="ISO"></a><a href="#8601"></a><a class="nohover" id="8601"></a>Date and time are to be combined into one variable according to ISO 8601</td>
 901 | </tr>
 902 | <tr>
 903 | <td class="seqw">2.2</td>
 904 | <td class="quew">What was the ECG time?</td>
 905 | <td class="answ">
 906 | <input type="text" placeholder="HH:MM"><span class="note"> Time</span><p class="note left">
 907 |           Always collect times as HH:MM and store times as ISO8601 in SDTM.
 908 |         </p>
 909 | </td>
 910 | <td id="anno" class="annw anno">
 911 | <a href="#EG.EGSTDTC"></a><a class="nohover" id="EG.EGSTDTC"></a>EG.EGSTDTC,<br><a href="#Date"></a><a class="nohover" id="Date"></a><a href="#and"></a><a class="nohover" id="and"></a><a href="#time"></a><a class="nohover" id="time"></a><a href="#are"></a><a class="nohover" id="are"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#be"></a><a class="nohover" id="be"></a><a href="#combined"></a><a class="nohover" id="combined"></a><a href="#into"></a><a class="nohover" id="into"></a><a href="#one"></a><a class="nohover" id="one"></a><a href="#variable"></a><a class="nohover" id="variable"></a><a href="#according"></a><a class="nohover" id="according"></a><a href="#to"></a><a class="nohover" id="to"></a><a href="#ISO"></a><a class="nohover" id="ISO"></a><a href="#8601"></a><a class="nohover" id="8601"></a>Date and time are to be combined into one variable according to ISO 8601</td>
 912 | </tr>
 913 | <tr>
 914 | <td class="seqw">2.3</td>
 915 | <td class="quew">What was the result of the ECG?</td>
 916 | <td class="answ">
 917 | <input type="radio" name="$radio"><label for="$radio">Normal<span class="note"> (NORMAL)</span></label><br><input type="radio" name="$radio"><label for="$radio">Abnormal<span class="note"> (ABNORMAL)</span></label><br>
 918 | </td>
 919 | <td id="anno" class="annw anno">
 920 | <a href="#EG.EGORRES"></a><a class="nohover" id="EG.EGORRES"></a>EG.EGORRES</td>
 921 | </tr>
 922 | <tr>
 923 | <td class="seqw">3.1</td>
 924 | <td class="quew">Was the ECG clinically significant?</td>
 925 | <td class="answ">
 926 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 927 | </td>
 928 | <td id="anno" class="annw anno">
 929 | <a href="#SUPPEG.QVAL"></a><a class="nohover" id="SUPPEG.QVAL"></a>SUPPEG.QVAL,<br><a href="#SUPPEG"></a><a class="nohover" id="SUPPEG"></a><a href="#QNAM"></a><a class="nohover" id="QNAM"></a><a href="#EGCLSIG"></a><a class="nohover" id="EGCLSIG"></a><a href="#SUPPEG"></a><a class="nohover" id="SUPPEG"></a><a href="#QLABEL"></a><a class="nohover" id="QLABEL"></a><a href="#ECG"></a><a class="nohover" id="ECG"></a><a href="#clinically"></a><a class="nohover" id="clinically"></a><a href="#significant"></a><a class="nohover" id="significant"></a><a href="#SUPPEG.QLABEL"></a><a class="nohover" id="SUPPEG.QLABEL"></a><a href="#SUPPEG.QNAM"></a><a class="nohover" id="SUPPEG.QNAM"></a>SUPPEG.QNAM='EGCLSIG', SUPPEG.QLABEL='ECG clinically significant'</td>
 930 | </tr>
 931 | </tbody>
 932 | </table>
 933 | <table class="maintable">
 934 | <p style="page-break-before: always;"></p>
 935 | <thead>
 936 | <tr><th colspan="4" class="noborder"><div class="left formtitle"><a class="nohover" id="F.0000"><span>Death</span></a></div></th></tr>
 937 | <tr><th colspan="4" class="noborder"><br></th></tr>
 938 | <tr>
 939 | <th class="crfhead seqw left">Ref</th>
 940 | <th class="crfhead quew">CRF Question</th>
 941 | <th class="crfhead answ">Data Collected</th>
 942 | </tr>
 943 | </thead>
 944 | <tbody>
 945 | <tr>
 946 | <td class="seqw">1.1</td>
 947 | <td class="quew">Were any death detail assessments collected?</td>
 948 | <td class="answ">
 949 | <input type="radio" name="$radio"><label for="$radio">No<span class="note"> (N)</span></label><br><input type="radio" name="$radio"><label for="$radio">Yes<span class="note"> (Y)</span></label><br>
 950 | </td>
 951 | <td id="anno" class="annw anno">
 952 | <a href="#NOT"></a><a class="nohover" id="NOT"></a><a href="#SUBMITTED"></a><a class="nohover" id="SUBMITTED"></a>NOT SUBMITTED</td>
 953 | </tr>
 954 | <tr>
 955 | <td class="seqw">2.1</td>
 956 | <td class="quew">Collection Date</td>
 957 | <td class="answ">
 958 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 959 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 960 |         </p>
 961 | </td>
 962 | <td id="anno" class="annw anno">
 963 | <a href="#DD.DDDTC"></a><a class="nohover" id="DD.DDDTC"></a>DD.DDDTC</td>
 964 | </tr>
 965 | <tr>
 966 | <td class="seqw">3.1</td>
 967 | <td class="quew">Death Date</td>
 968 | <td class="answ">
 969 | <input type="text" placeholder="DD-MMM-YYYY"><span class="note"> Date</span><p class="note left">
 970 |           Always collect dates as DD-MMM-YYYY and store dates as ISO8601 in SDTM.
 971 |         </p>
 972 | </td>
 973 | <td id="anno" class="annw anno">
 974 | <a href="#DD.DTHDTC"></a><a class="nohover" id="DD.DTHDTC"></a>DD.DTHDTC</td>
 975 | </tr>
 976 | <tr>
 977 | <td class="seqw">4.1</td>
 978 | <td class="quew">What is the primary cause of death?</td>
 979 | <td class="answ">
 980 | <input type="text"><span class="note"> Text</span>
 981 | </td>
 982 | <td id="anno" class="annw anno">
 983 | <a href="#DD.DDORRES"></a><a class="nohover" id="DD.DDORRES"></a>DD.DDORRES,<br><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTESTCD"></a><a class="nohover" id="DDTESTCD"></a><a href="#DIAGPRIM"></a><a class="nohover" id="DIAGPRIM"></a><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTEST"></a><a class="nohover" id="DDTEST"></a><a href="#Primary"></a><a class="nohover" id="Primary"></a><a href="#Diagnosis"></a><a class="nohover" id="Diagnosis"></a><a href="#DD.DDTEST"></a><a class="nohover" id="DD.DDTEST"></a><a href="#DD.DDTESTCD"></a><a class="nohover" id="DD.DDTESTCD"></a>DD.DDTESTCD='DIAGPRIM', DD.DDTEST='Primary Diagnosis'</td>
 984 | </tr>
 985 | <tr>
 986 | <td class="seqw">4.2</td>
 987 | <td class="quew">What is the secondary cause of death?</td>
 988 | <td class="answ">
 989 | <input type="text"><span class="note"> Text</span>
 990 | </td>
 991 | <td id="anno" class="annw anno">
 992 | <a href="#DD.DDORRES"></a><a class="nohover" id="DD.DDORRES"></a>DD.DDORRES,<br><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTESTCD"></a><a class="nohover" id="DDTESTCD"></a><a href="#DIAGSEC"></a><a class="nohover" id="DIAGSEC"></a><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTEST"></a><a class="nohover" id="DDTEST"></a><a href="#Secondary"></a><a class="nohover" id="Secondary"></a><a href="#Diagnosis"></a><a class="nohover" id="Diagnosis"></a><a href="#DD.DDTEST"></a><a class="nohover" id="DD.DDTEST"></a><a href="#DD.DDTESTCD"></a><a class="nohover" id="DD.DDTESTCD"></a>DD.DDTESTCD='DIAGSEC', DD.DDTEST='Secondary Diagnosis'</td>
 993 | </tr>
 994 | <tr>
 995 | <td class="seqw">4.3</td>
 996 | <td class="quew">What is the location of death?</td>
 997 | <td class="answ">
 998 | <input type="radio" name="$radio"><label for="$radio">Home<span class="note"> (HOME)</span></label><br><input type="radio" name="$radio"><label for="$radio">Hospital<span class="note"> (HOSPITAL)</span></label><br><input type="radio" name="$radio"><label for="$radio">Nursing/Rehabilitation Home<span class="note"> (NURSING/REHABILITATION HOME)</span></label><br>
 999 | </td>
1000 | <td id="anno" class="annw anno">
1001 | <a href="#DD.DDORRES"></a><a class="nohover" id="DD.DDORRES"></a>DD.DDORRES,<br><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTESTCD"></a><a class="nohover" id="DDTESTCD"></a><a href="#LOCDTH"></a><a class="nohover" id="LOCDTH"></a><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTEST"></a><a class="nohover" id="DDTEST"></a><a href="#What"></a><a class="nohover" id="What"></a><a href="#is"></a><a class="nohover" id="is"></a><a href="#the"></a><a class="nohover" id="the"></a><a href="#location"></a><a class="nohover" id="location"></a><a href="#of"></a><a class="nohover" id="of"></a><a href="#death"></a><a class="nohover" id="death"></a><a href="#DD.DDTEST"></a><a class="nohover" id="DD.DDTEST"></a><a href="#DD.DDTESTCD"></a><a class="nohover" id="DD.DDTESTCD"></a>DD.DDTESTCD='LOCDTH', DD.DDTEST='What is the location of death'</td>
1002 | </tr>
1003 | <tr>
1004 | <td class="seqw">4.4</td>
1005 | <td class="quew">Was the death witnessed?</td>
1006 | <td class="answ">
1007 | <input type="text"><span class="note"> Text</span>
1008 | </td>
1009 | <td id="anno" class="annw anno">
1010 | <a href="#DD.DDORRES"></a><a class="nohover" id="DD.DDORRES"></a>DD.DDORRES,<br><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTESTCD"></a><a class="nohover" id="DDTESTCD"></a><a href="#DTHWIT"></a><a class="nohover" id="DTHWIT"></a><a href="#DD"></a><a class="nohover" id="DD"></a><a href="#DDTEST"></a><a class="nohover" id="DDTEST"></a><a href="#Was"></a><a class="nohover" id="Was"></a><a href="#Death"></a><a class="nohover" id="Death"></a><a href="#Witnessed"></a><a class="nohover" id="Witnessed"></a><a href="#DD.DDTEST"></a><a class="nohover" id="DD.DDTEST"></a><a href="#DD.DDTESTCD"></a><a class="nohover" id="DD.DDTESTCD"></a>DD.DDTESTCD='DTHWIT', DD.DDTEST='Was Death Witnessed'</td>
1011 | </tr>
1012 | </tbody>
1013 | </table>
1014 | </body>
1015 | </html>
1016 | 


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