Rockville, MD 20857, or by email at 113trials@oc.fda.gov, or by fax at 301–443–4555.

L. Is Institutional Review Board preapproval of the protocol listing required?

No. Section 113 of the Modernization Act does not require prior IRB approval when submitting this information to the Clinical Trials Data Bank. Current FDA guidance recommends that IRB review of listings need not occur when, as here, the system format limits the information provided to basic information, such as title, purpose of the study, protocol summary, basic eligibility criteria, study site locations, and how to contact the site for further information.11

M. Will FDA monitor compliance?

A copy of the protocol listing in ClinicalTrials.gov will be sent to the FDA. FDA’s Office of Special Health Issues intends to initiate a one-year pilot educational program in 2002 that will include a component to evaluate compliance. The primary objective of the pilot program is to educate sponsors about the existence of the guidance document and the availability of the online PRS data entry tool. The secondary objective of the pilot program is to evaluate the success of the educational initiative. The pilot, which will measure the number of protocols (voluntary and required) made available through the ClinicalTrials.gov database, will provide FDA with compliance information.

11  

The 1998 update of Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators provides guidance on IRB review and approval of listings of clinical trials on the Internet. See http://www.fda.gov/oc/ohrt/irbs/toc4.html#recruiting.



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