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PART I - BACKGROUND
Since the Investigational New Drug Regulations went into effect in 1963, *the Food and Drug Administration (FDA)* has exercised oversight of the conduct of studies with regulated products. The Bioresearch Monitoring Program was established in 1977 by a task force, *that* included representatives from the drug, biologic, devices, veterinary *drug* and food areas. *Compliance programs (CP) were developed *to provide uniform guidance and specific instruction for* inspections of clinical investigators (CP 7348.811), sponsors (CP 7348.810), biopharmaceutic laboratories (CP 7348.001) now known as in-vivo bioequivalence, institutional review boards (CP 7348.809) and *nonclinical* laboratories (CP 7348.808).
New regulations dealing with obligations of clinical investigators, sponsors and monitors (21 CFR Parts 312, 314, 511 and 514) were published on March 19, 1987, and became effective on June 17, 1987. Regulations *for clinical investigations of devices* (21 CFR Part 812) became effective January 18, 1980.*
*Guidance documents for the monitoring of clinical investigations were published in January 1988 and May 1997, ICH Good Clinical Practice: Consolidated Guideline* (for human drugs and biologics); and Good Target Animal Study Practices: Clinical Investigators and Monitors (for veterinary drugs).*
*Current Changes*
Hypertext updated August 20,1998 by djv