Periodic Site Review
At the time of initial review of research, the Board establishes an approval period for an approved study. Regulations require Continuing Review of the research at least once per year and more frequently if determined necessary by the Board. Approval to investigators to conduct research at their particular site(s) is tied to the protocol approval. The expiration date of an investigator’s Board approval will be noted on the “Notice of Approval”, and “Site Status Reports.” Reminders about the Site Status Report due date will be noted on subsequent “Amended Approvals.”
In order for Board approval of a study to be extended beyond the current approval period’s expiration date, the investigator must submit a completed “Site Status Report for Periodic Site Review” for the site (and, sometimes, for the sponsor in the case of investigator Sponsored Research). The completed form should be returned to Quorum Review IRB at least six (6) weeks prior to the approval expiration date to allow adequate time for Board review.
In the case of principal investigator Generated Studies, the Protocol Continuing Review Report also needs to completed by the principal investigator and returned to Quorum at least six (6) weeks prior to the approval expiration date. The Protocol Continuing Review Report captures study-level information. The Board will conduct a continuing review of the protocol at the same meeting that the site periodic review is performed.
Quorum Review IRB considers a study closed at a site only if there are no actively enrolled participants, all interventions with participants have ceased, and the sponsor/CRO has closed the study site. Please note that being “closed to enrollment” does not meet Quorum Review IRB’s definition of study closure.
Once all participants have completed a study and all interventions with participants have ceased, Quorum Review IRB considers the date of study closure to be the date on which a representative of the sponsor administratively closes the study at the research site. Quorum Review IRB will not accept “Site Status Reports for Closing” that are received before the date of study closure.
Quorum Review IRB will send the investigator and sponsor a letter of acknowledgement of site closure. Although Quorum Review IRB will accept further information submitted for a closed research site, no approvals of additions or changes to research activities will be issued.