ABSTRACT
PURPOSE The purpose of this guideline is to present acceptable approaches to monitoring clinical investigations. Existing requirements for sponsors of clinical investigations involving new drugs for human and animal use (including biological products for human use) and medical devices under 21 CFR Parts 312 and 511, and 812 and 813, respectively, require that a sponsor monitor the progress of a clinical investigation. The monitoring functions may be delegated to a contract research organization as defined under 21 CFR 312.3. Proper monitoring is necessary to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data submitted to the Food and Drug Administration (FDA).
INTRODUCTION of practice that is acceptable to FDA. A sponsor may rely upon this guideline or may develop different procedures. A sponsor who selects different procedures for monitoring a clinical investigation may, but is not required to, submit those procedures to FDA for review and comment to avoid the possibility of employing monitoring procedures that FDA might later determine to be inadequate. Sponsors wishing to obtain such a review should contact FDA’s Bioresearch Program Coordinator (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
