Sponsor Reporting

Before each annual review, WCG IRB sends out a Protocol Continuing Review Report (PCRR) to the sponsor or CRO contact that we have on file. The PCRR is designed to collect protocol-wide data as recommended in the FDA guidance document titled “IRB Continuing Review after Clinical Investigation Approval.” In this guidance, FDA recommends several times that both central and local IRBs should obtain and review protocol information. We ask that you complete and return the PCRR before the due date indicated on the form. The individual study sites will continue to receive separate site progress reports to complete and submit as well. 

WCG IRB aims to make the PCRR process as efficient as possible for all parties. Therefore, WCG IRB will accept receipt of the completed PCRR form from any party.

In addition, FDA notes in the guidance that existing sponsor reports containing the requested data could be re-purposed for the purposes of reporting protocol wide information to the IRB, such as annual Progress Reports or the Development Safety Update Reports (DSUR) Executive Summary. WCG IRB is flexible as to the format in which this information is received and will accept other reports that provide the same basic information.

The PCRR is sent out approximately 100 days before the protocol’s expiration date and are due approximately 56 days before the expiration date in order to ensure it is completed and sent back to WCG IRB before the Board conducts the continuing review of the study. 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. The Board may take action to suspend or terminate approval of the research if a report is not accurately completed and returned promptly.

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