Monitoring of clinical investigations; availability of guideline--FDA. Notice.
The Food and Drug Administration (FDA) announces the availability of a guideline entitled "Guideline for the Monitoring of Clinical Investigations." The guideline describes approaches acceptable to FDA for monitoring clinical investigations involving any FDA-regulated product--human drugs, biological products for human use, medical devices for human use, food additives, color additives, and veterinary drugs. The guideline is intended to facilitate compliance with the requirement for sponsors to monitor the progress of a clinical investigation. Proper monitoring of a clinical investigation is necessary to assure protection of the rights of human subjects involved in the investigation, the safety of all subjects involved, and the quality and integrity of the resulting data submitted to FDA.
D002986:Clinical Trials as Topic / Q000592:standards*; D006805:Human Experimentation; D014481:United States; D014486:United States Food and Drug Administration