Are annual IRB reviews required when all studies are reviewed by the IRB each quarter?

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The IRB records for each study's initial and continuing review should note the frequency (not to exceed one year) for the next continuing review in either months or other conditions, such as after a number of subjects are enrolled.

An IRB may decide to review all studies on a quarterly basis. If every quarterly report contains sufficient information for an adequate continuing review and is reviewed by the IRB under procedures that meet FDA requirements for continuing review, FDA would not require an additional "annual" review.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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