Site Reporting

Completed Site Continuing Review Report Forms (CRRFs) provide the IRB with the study-related data necessary to monitor the progress of the research at sites. Identifying information including investigator name, sponsor name, protocol number and the “sequence” number of the form is listed at the top of each form. The CRRF is sent out approximately 86 days before the study’s expiration date, in order to ensure it is completed and sent back to us before the Board conducts the study renewal review. The Board may take action to suspend or terminate approval of the research if a report is not accurately completed and returned promptly.

CRRFs must be filled out completely and returned to us approximately 56 days before the study expiration date. This time frame allows for IRB staff to review the completed form, follow up if they have questions, and send it to Board with the study renewal review. If we have not yet received a completed report form, two “Reminder Notices” are sent out; one at about two weeks and another about four days prior to the due date of the form. 

Even if the site has not started enrolling participants, the site must complete the CRRF and return it to WCG IRB before the due date printed on it, to inform the Board of the study’s status at the site. 

Please ensure reports are complete and consistent with previous reporting. Incomplete and inconsistent information may result in delayed reviews.

As a reminder, it is the Principal Investigator’s responsibility to ensure a current medical license, if applicable, is on file with the IRB.