Load CDASH Metadata

From DOC

Contents 1 Objectives 2 Source File 3 Article Title 4 Article Content 5 Redirects 6 Summary

Objectives

• CDASH is loaded to the Wiki under program control
• Loaded content is to be read only by end-users
• End-users are encouraged to comment on CDASH content using the Discussion (talk) pages behind each CDASH page
• The loaded content will be versioned (in the usual way) such that only updated terms will get a new article version in the Wiki.
• The loaded content is represented both visually and semantically
• One article per CDASH data element
• An additional article per CDASH alias that redirects to the main data element article

Source File

cdash xml

The primary source data is the ItemDef elements. XPATH:

ODM/Study/MetaDataVersion/ItemDef

Each ItemDef results in an article added to the wiki. An example of one ItemDef:

<ItemDef OID="Common_8_2008-10-28" Name="Time of Visit" DataType="text" cdash:Domain="Common" cdash:Core="Optional" Length="999">
  <Description>
    <TranslatedText xml:lang="en">Time the visit took place.</TranslatedText>
  </Description>
  <Question>
    <TranslatedText xml:lang="en">What was the Visit Tims?</TranslatedText>
  </Question>
  <Alias Name="VISTIM" Context="CDASH"/>
    <cdash:InstructionsToSite>
        <TranslatedText xml:lang="en">Record the time the visit took place.</TranslatedText>
    </cdash:InstructionsToSite>
    <cdash:Rationale>
        <TranslatedText xml:lang="en">This may be useful for Phase I trials.</TranslatedText>
    </cdash:Rationale>
</ItemDef>

Article Title

The article title (page name) is composed as follows:

1. Name element
2. A space
3. The string (CDASH)

For example, the article title for the above ItemDef would be:

Time of Visit (CDASH)

Article Content

The ItemDef heading is taken almost verbatim from the ItemDef element:

{{ItemDef (CDASH)|oid=Common_2_2008-10-28|Name=Site Identifier Within a Study
|DataType=text|domain=common|core=Highly Recommended|Length=999}}

The description can be included in the article as it exists in XPath Description/TranslatedText. For example:

Unique identifier for the study site; however, SITEID is also unique within a submission.

The Question (Xpath Question/TranslatedText) must be semantically encoded so it should be represented as a template call:

{{Question (CDASH)|What was the site number?}}

Alias strings, of which there may be more than one, must be semantically encoded.

{{Alias (CDASH)|SITENO}}

Instructions to site must also be semantically encoded.

{{SiteInstructions (CDASH)|Record your clinical site’s identifier as defined by the sponsor.}}

Rationale is free text in the article with a prefix of Rationale:

==== Rationale ====
Paper: This is typically pre-printed in the header of each CRF page for single 
site studies. For studies with multiple sites, this field is typically left 
blank so that the number can be recorded by the site. 
EDC: This should be pre-populated. If SITEID is not used, SITENO should be 
used to derive SITEID for SDTM, depending upon sponsor’s site identification scheme.

Redirects

A separate article should be created fo each Alias entry. The name of the article should be the Alias followed by (CDASH). For example:

SITENO (CDASH)

Note: Verify that the Alias is not the same as the article. CDASH uses a free-text format in alias rather than properly encoded in XML.

The body of the article is just a redirect to the main article. For example:

#REDIRECT [[Time of Visit (CDASH)]]

The target article must be the exact name of the main article.

Summary

A full article should look something like this:

{{ItemDef (CDASH)|oid=Common_2_2008-10-28|Name=Site Identifier Within a Study
|DataType=text|domain=common|core=Highly Recommended|Length=999}}
Unique identifier for the study site; however, SITEID is also unique within a submission.
{{Question (CDASH)|What was the site number?}}
{{Alias (CDASH)|SITENO}}
{{SiteInstructions (CDASH)|Record your clinical site’s identifier as defined by the sponsor.}}
==== Rationale ====
Paper: This is typically pre-printed in the header of each CRF page for single 
site studies. For studies with multiple sites, this field is typically left 
blank so that the number can be recorded by the site. 
EDC: This should be pre-populated. If SITEID is not used, SITENO should be 
used to derive SITEID for SDTM, depending upon sponsor’s site identification scheme.