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 research. 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)]. Beginning in May 2009, for most types of research, the Board requires two reports per approval period, and conducts full board re-review annually. For a few types of research, however, full board review is conducted more frequently than once a year. The Board normally determines that a full review of phase I research, investigator-initiated single-site interventional studies of investigational drugs and devices, emergency research conducted under 21 CFR 50.24, and child research conducted under 45 CFR 46.407 should be conducted every six months. The Board may also direct more frequent than annual review for other research as deemed appropriate. Sites approved for 6 months at a time should expect to receive and complete four reports per year (two for each six month approval period).

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, according to the frequency established by the Board. 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 due date is also listed at the top of the form. Over the course of a year, studies assigned to a two per period reporting cycle will receive one "Interim" CRRF and one "Study Renewal" CRRF. The Study Renewal CRRF is sent out approximately 50 days before the study's expiration date, in order to ensure it is completed and sent back to WIRB before the Board conducts the study renewal review. The Board may take action to suspend or terminate approval of the research if reports are not accurately completed and returned promptly.

CRRFs must be filled out completely and returned to WIRB in a timely manner. Even if the site has not started enrolling subjects, the site must complete the CRRF and return it he WIRB before the due date printed on it, to inform the Board of the study's status at the site.

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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