Clinical Research Support

Annual Renewal

Follow-up reviews are required for several of the bodies that review studies initially. Generally the review cycle is once a year, but it is sometimes more frequent. Below you'll find information about some of the review processes you may encounter during the conduct of a study. For further information, contact Clinical Research Support.

Food and Drug Administration (FDA)

An annual report is a summary of the progress of the clinical investigation and information obtained during the previous year's clinical and non-clinical investigations.

Annual reports to the FDA are due within 60 days of the anniversary of the effective date. For example, if an IND was submitted on February 17, 2005, and FDA did not have any comments or questions, then the IND went into effect on March 17, 2005 (after the 30-day waiting period). Thus, the annual report is due on or before May 17, 2006. The annual report is due on or before the same day of each subsequent year.

When is an IND 'in effect'? The IND goes into effect thirty days (30) after the FDA receives the IND, unless the FDA notifies that the investigation described in the IND is subject to a clinical hold, or FDA notifies the sponsor that the described investigation may begin. The format and content of the annual report is described in 21 CFR 312.33.

Radiation Safety Committee

Radiation Safety Committees require review yearly.  More information can be found here.

Institutional Review Board (IRB)

DHHS regulation 45CFR46.109(e) requires that the IRB review human subjects research at intervals appropriate to the degree of risk, but not less than once per year. You can find out more about the IRB review process here.

Protocol Data Monitoring Committee (PDMC)

Protocol Data Monitoring Committee is part of the Protocol Review & Monitoring System along with Scientific Review.  This review is conducted just prior to IRB review using some of the same materials.  More information can be found here.

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