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Study Status Reporting: Periodic and Continuing

SponsorsPeriodic Review supports the Research Site reapproval process. If the study at your site will last beyond the approval period, you must fill out a Study Status Report indicating Periodic Review as the report type.

These may be submitted up to eight weeks prior to the expiration date noted on the original approval letter, or most recent reapproval letter, allowing the Board adequate time to conduct the review.

Include a subject-signed and dated copy of the most recent version of the informed consent, as well as any addendum consents and sub-study consents that have not been previously submitted.

A delay in your submission could result in your site conducting research without IRB approval, which is a violation of FDA and Health Canada U.S. and Canadian regulations. If the Board does not receive a report for periodic review in a timely manner, the sponsor or CRO/SMO will be notified and study approval may lapse. In the event that IRB approval lapses, you must stop consenting new subjects and cease all study-related activities during this period.

Once reviewed and any follow-up issues are resolved, we will issue a letter indicating the reapproval status of the study at your site.

What is Continuing Review?

Continuing Review supports the Study Protocols reapproval process. Federal regulations authorize IRBs to approve studies for no more than one year and a Board may approve a protocol for a shorter period, appropriate to the degree of risk.

If the Board does not receive a continuing review request in a timely manner, study approval may lapse. All sites under Schulman review must stop consenting new subjects and cease all study-related activities during the period that IRB approval has lapsed.

Once reviewed and any follow-up issues are resolved, we will issue a letter indicating the reapproval status of the study.