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.

Data and Safety Monitoring Committee (DSMC)

All clinical trials subject to SRC review are required to submit information to the Data and Safety Monitoring Committee (DSMC) at annual renewal. This committee has replaced the Protocol Data Monitoring Committee (PDMC).

DSMC reviews study information depending on type of trial (as outlined below) and may recommend continuation, suspension, or closure of a study.

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.

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.

Radiation Safety Committee

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

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