Good Clinical Practice Contacts

Good Clinical Practice Program (GCPP)

Members of our staff:

• David A. Lepay, M.D., Ph.D., Senior Advisor for Clinical Science and Director, Good Clinical Practice Program
• Patricia Beers Block, Special Assistant to the Director
• Bonnie M. Lee, Associate Director for Human Subject Protection Policy
• Stan W. Woollen, Associate Director for Bioresearch Monitoring
• Carolyn Hommel, Expert Consumer Safety Officer

Contact the Good Clinical Practice Program if you have:

• general questions about FDA good clinical practice regulations and policy
• general questions about the FDA clinical Bioresearch Monitoring Program, and specifically clinical investigator, Institutional Review Board (IRB), sponsor, monitor, and contract research organization programs
• questions about or suggestions related to FDA's Information Sheets for IRB's and Clinical Investigators
• questions about reports made pursuant to 21 CFR 56.108(b) and 56.113 involving an FDA-regulated product if you do not know which FDA Center has jurisdiction (e.g., drug, medical device, biological product), including:
  • unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)]
  • serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations [21 CFR 56.108(b)(2)]
  • suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]

Questions about Good Clinical Practice

Submit questions via email, in writing, or direct them to our general telephone number. We try to respond to each question as soon as possible. (Please note: FDA cannot comment about products that are in the review process. We cannot comment about clinical trials for specific products, diseases, or conditions. We cannot answer questions about when a new product subject to pre-market approval will be approved or not approved.)

Enforcement Information

Division of Compliance Policy
Office of Enforcement
Office of Regulatory Affairs
Phone: 301-827-0425
Fax: 301-827-0482

Contact the Division of Compliance Policy for questions about:

• questions about the overall FDA Bioresearch Monitoring Program, and specifically the Good Laboratory Practice (GLP, nonclinical laboratories) Program
• general Bioresearch Monitoring program enforcement issues

Drug Products

Division of Scientific Investigations (DSI)
Office of Medical Policy
Center for Drug Evaluation and Research (CDER)
Telephone: 301-594-0020
Facsimile: 301-594-1204
Website: www.fda.gov/cder/Offices/DSI/index.htm

Contact the Division of Scientific Investigations for questions about:

• Human subject protection regulations pertaining to drugs (21 CFR Parts 50, 56, 312, 361)
• CDER-assigned IRB inspections (e.g., FDA-483's)
• Reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a drug product including:
  • unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)]
  • serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations [21 CFR 56.108(b)(2)]
  • suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]
• reporting complaints related to human subject protection/Good Clinical Practice in FDA-regulated drug trials

Biological Products

Bioresearch Monitoring Branch
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research (CBER)
Telephone: 301-827-6221
Facsimile: 301-827-6748

Contact the Bioresearch Monitoring Branch for questions about:

• The legal status of a test article
• Human subject production regulations relating to biologics
• CBER assigned IRB inspections
• CBER assigned Clinical Investigator inspections
• Reports made pursant to 21 CFR 56.108(b) and 56.113 involving a biologic product including:
  • unanticipated problems involving risks to subjects
  • serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations
  • suspension or termination of IRB approval of a protocol

Medical Devices

Division of Bioresearch Monitoring
Office of Compliance
Center for Device and Radiological Health (CDRH)
Phone: 301-594-4718
Fax: 301-594-4731
Website: www.fda.gov/cdrh/comp/bimo.html

Contact the Division of Bioresearch Monitoring for questions about:

• Human subject protection regulations pertaining to devices [21 CFR Parts 50, 56, and 812]
• Informed consent, standard operating procedures, records and reports
• Serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations involving a medical device [21 CFR 56.108(b)(2)]
• Reporting complaints related to human subject protection/Good Clinical Practice in FDA-regulated medical device trial