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  1. Clinical Trials and Human Subject Protection

Good Clinical Practice Contacts

Office of Good Clinical Practice (OGCP)

Contact the Office of Good Clinical Practice if you have:

  • Questions about FDA good clinical practice regulations and policy
  • Questions about FDA human subject protection regulations and policy
  • Questions about or suggestions related to FDA's Information Sheets for IRBs and Clinical Investigators or FDA guidance on good clinical practice or human subject protection issues
  • 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)]

How to contact the Office of 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.)

E-mail: gcp.questions@fda.hhs.gov
Telephone: 301-796-8340
Facsimile: 301-847-8640
Write:
Food and Drug Administration
Office of Good Clinical Practice
Office of Medical Products and Tobacco
10903 New Hampshire Ave., WO32-5103
Silver Spring, MD 20993


Members of our staff:

  • Joanne R. Less, Ph.D., Director, Office of Good Clinical Practice
  • Sheila Brown, R.N., M.S., Policy Analyst
  • Janet Donnelly, RAC, Policy Analyst
  • Carol Drew, JD, Senior Regulatory Counsel
  • Bridget Foltz, MS, MT(ASCP), Policy Analyst
  • Doreen Kezer, M.S.N., Senior Health Policy Analyst
  • Patrick McNeilly, Ph.D., R.Ph., Senior Health Policy Analyst
  • Janet Norden, M.S.N., R.N., Senior Regulatory Policy Advisor
  • Kevin A. Prohaska, D.O., M.P.H., Senior Medical Policy Analyst
  • Jeff Ramsay, PMP, Project Manager