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Trial documentation and study versions
Trial documentation has versions in the same way that a trial does. The version of a set of trial documentation is tied to a study version through the VERSIONDESCRIPTION attribute of the following MedML elements:
- STUDYVERSION—Assigns a version to a set of FORMSETS (visits).
- STUDYVERSIONDOC—Assigns a version to a set of trial documentation and associates the trial documentation with a specific study version.
- STUDYVERSIONSITE—Applies a study version and the trial documentation that is associated with it to a site.
If the trial documentation changes after you initially install it, you must update the study version of the trial if you want the new version of the documentation to apply only to new patients.
<MEDMLDATA>
<STUDYVERSION
VERSIONDESCRIPTION="1"
STUDYNAME="Hypertension Study"
PROTOCOL="Protocol XYZZY">
<FORMSET REFNAME="Visit1" TITLE="Week -4"
LANGUAGE="English"TYPE="Visit"
SCHEDULED="true"ORDER="1">
<FORMREF REFNAME="DEM"/>
<FORMREF REFNAME="FH"/>
</FORMSET>
<FORMSET REFNAME="Visit2" TITLE="Week -2"
TYPE="Visit"SCHEDULED="true">
<FORMREF REFNAME="VS"/>
</FORMSET>
<.STUDYVERSION>
</MEDMLDATA>
The VERSIONDESCRIPTION attribute of the trial documentation must match the VERSIONDESCRIPTION attribute of the study version.
<MEDMLDATA>
<!-- Documents -->
<STUDYVERSIONDOC VERSIONDESCRIPTION="1" DOCREFNAME="Protocol" ORDER="1"/>
<STUDYVERSIONDOC VERSIONDESCRIPTION="1" DOCREFNAME="Study" ORDER="2"/>
<STUDYVERSIONDOC VERSIONDESCRIPTION="1" DOCREFNAME="Visit" ORDER="3"/>
<STUDYVERSIONDOC VERSIONDESCRIPTION="1" DOCREFNAME="CRB" ORDER="4"/>
</MEDMLDATA>
The VERSIONDESCRIPTION attribute of the study version and trial documentation must match the VERSIONDESCRIPTION attribute of each site where the versions are updated.
<STUDYVERSIONSITE VERSIONDESCRIPTION="1" SITEMNEMONIC="PF" ACCEPTDATE="6/30/1998" />
<STUDYVERSIONSITE VERSIONDESCRIPTION="1" SITEMNEMONIC="BID" ACCEPTDATE="6/30/1998" />
<STUDYVERSIONSITE VERSIONDESCRIPTION="1" SITEMNEMONIC="BCH" ACCEPTDATE="6/30/1998" />
<STUDYVERSIONSITE VERSIONDESCRIPTION="1" SITEMNEMONIC="MGH" ACCEPTDATE="6/30/1998" />
<STUDYVERSIONSITE VERSIONDESCRIPTION="1" SITEMNEMONIC="BWH" ACCEPTDATE="6/30/1998" />
