WIRB | Western Institutional Review Board

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Home > Investigator/SMO > Continuing Review Activities and Reports

Overview of WIRB's continuing review activities and reports

Continuing Review
Continuing Review Report Forms (CRRFs)
Study Closure
Site Visits

Continuing Review

During the initial review of a protocol, the Board makes a determination on the required frequency for reporting information related to the studies. FDA regulations regarding continuing review require an IRB to conduct continuing review of the research at intervals appropriate to the degree of risk, but not less than once per year [21 CRF § 56.108 (a)(1) and § 56.109(f)]. The Board normally requires quarterly reporting (four times per year), and conducts full board re-review annually.

Completed Continuing Review Report Forms provide WIRB with the study-related data necessary to monitor the progress of the research at sites. WIRB sends sites a CRRF three weeks prior to the due date established by the Board. Identifying information including investigator name, sponsor name, protocol number and "sequence" number of the form is listed at the top of each form. The due date is also listed at the top of the form. Over the course of a year, studies assigned to a "quarterly" reporting cycle will receive three "Interim" CRRFs and one "Study Renewal" CRRF (approximately 52 days before the study's expiration date).

CRRFs must be filled out completely and returned to WIRB in a timely manner. Even if the site has not started enrolling subjects, this must be indicated on the CRRF and returned to WIRB to inform the Board of the study's status at the site. The Board may take action to suspend or terminate approval of the research if reports are not accurately completed and returned promptly.
Before sending a completed report form to WIRB, verify that the reported data (specifically, enrollment numbers) do not conflict with any previous reports to WIRB. WIRB will not accept data inconsistent with prior reports. If reported data conflicts with the previous report, WIRB will contact the site to obtain corrected information. This may delay or hinder study renewal.

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