" /> Study Site Protocol Version Relationship - CISMeF





Preferred Label : Study Site Protocol Version Relationship;

NCIt related terms : StudySiteProtocolVersionRelationship;

NCIt definition : Specifies the link between a study site and a version of the study protocol used or available for use at that site.;

Alternative definition : BRIDG 3.0.3: Specifies the link between a study site and a version of the study protocol used or available for use at that site. NOTE(S): Even if a study site's IRB has not reviewed the study protocol version, if there is a new version for the study protocol, then there is the potential for a relationship between the site and the version. The dateRange is specified only if the version is approved for this site by the IRB and activated at the site. Retroactive approval means that the dateRange does not have to be on or after the IRB approval date.; BRIDG 5.3: Specifies the link between a study site and a version of the study protocol used or available for use at that site. EXAMPLE(S): OTHER NAME(S): NOTE(S): Even if a study site's IRB has not reviewed the study protocol version, if there is a new version for the study protocol, then there is the potential for a relationship between the site and the version. The dateRange is specified only if the version is approved for this site by the IRB and activated at the site. Retroactive approval means that the dateRange does not have to be on or after the IRB approval date.;

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11/05/2024


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