Study Site Protocol Version Relationship

Definition 1

Specifies the link between a study site and a version of the study protocol used or available for use at that site. (NCI Thesaurus)

Definition 2

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. (NCI Thesaurus/BRIDG)

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Study Site Planned Duration

The intended period of time for the study site's participation in the study.

Study Site Personnel Telecom Address

A sequence of digits or characters used to identify a particular telephone, fax, or email of a study site personnel.

Study Site Personnel Role Code

The coded value specifying a type of responsibility of the study site personnel.

Study Site Personnel Primary Indicator

Specifies whether this is the main or principal study site personnel.

Study Site Personnel Postal Address

A contact point used to send physical forms of communication to the study site personnel.

Study Site Personnel Effective Date Range

The date and time span for when the study site personnel is active.