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  4. FDA Bioresearch Monitoring Information
  5. PART VI - REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS
  1. FDA Bioresearch Monitoring Information

PART VI - REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS

A. REFERENCES

  1. FDA Laws

    Federal Food Drug and Cosmetic Act (FFDCA)

  2. Most Relevant 21 CFR Regulations

    Part 50 Protection of Human Subjects

    Part 56 Institutional Review Boards

    Part 312 Investigational New Drug Application

    Part 511 New Animal Drugs for Investigational Use

    Part 812 Investigational Device Exemptions

  3. Other 21 CFR Regulations

    Part 11 Electronic Records; Electronic Signatures,

    Part 54 Financial Disclosure by Clinical Investigators

    Part 314 Applications for FDA Approval to Market a New Drug or Antibiotic Drug

    Part 514 New Animal Drug Applications

    Part 601 Licensing (Applications for FDA Approval of a Biologic License)

    Part 814 Premarket Approval of Medical Devices

  4. FDA Guidelines, Guidances, and Inspection Guides

    FDA Information Sheet Guidances for Institutional Review Boards and Clinical Investigators (http://www.fda.gov/oc/ohrt/irbs/default.htm)

    Guidance for Industry: International Conference on Harmonization (ICH) E6, Good Clinical Practice: Consolidated Guidance (http://www.fda.gov/cder/guidance/959fnl.pdf)

    Guidance for Industry: Computerized Systems Used in Clinical Investigations (http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf)
    Guidance for Industry: Part 11: Electronic Records, Electronic Signatures-- Scope and Application (http://www.fda.gov/ohrms/dockets/98fr/5667fnl.pdf)

    Guidance for Industry: Financial Disclosure by Clinical Investigators (http://www.fda.gov/oc/guidance/financialdis.html)

    General Principles of Software Validation; Final Guidance for Industry and FDA Staff (http://www.fda.gov/cdrh/comp/guidance/938.html)

    Investigations Operations Manual (IOM), Sections 5.3.8.3 (Filmed or Electronic Records) and 5.3.8.4 (Requesting and Working with Computerized Complaint and Data Failure) (http://www.fda.gov/ICECI/Inspections/InvestigationsOperationsManual/ucm122531.htm)

    Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators (http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0173-gdl0001.pdf)

    Guidance for Industry (Guidance 85): Veterinary International Conference on Harmonization (VICH) GL9, Good Clinical Practice, Final Guidance (http://www.fda.gov/cvm/vich.html)

    Compliance Policy Guide # 7150.09 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities (http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg120-100.html)

    Compliance Policy Guide # 7151.02 FDA Access to Results of Quality Assurance Program Audits and Inspections (http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg130-300.html)

    Guidance for Industry and Food and Drug Administration Staff: The Review and
    Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program (http://www.fda.gov/cdrh/comp/guidance/1566.pdf)

B. PROGRAM CONTACTS

  1. When medical, technical or scientific questions or issues arise from a specific assignment or if additional information is required about a specific assignment, consult the Center contact identified in the assignment.
  2. For operational questions, contact:

    Office of the Associate Commissioner for Regulatory Affairs
    Office of Regional Operations (ORO)
    Division of Field Investigations: Ruark Lanham, HFC-130
    301-827-6691, FAX 301-443-3757

  3. For questions about GCP and Compliance program issues, specific to a Center product area, contact:

    Center for Drug Evaluation and Research (CDER)
    Division of Scientific Investigations:
    Leslie Ball, M.D., HFD-45
    301-796-3399, FAX 301-847-8748

    Center for Biologics Evaluation and Research (CBER)
    Bioresearch Monitoring Staff:
    Patricia Holobaugh, HFM-664
    301-827-6221, FAX 301-827-6748

    Center for Veterinary Medicine (CVM)
    Bioresearch Monitoring and Administrative Actions Team:
    Vernon Toelle, Ph.D., HFV-234
    240-276-9238, FAX 240-276-9241

    Center for Devices and Radiological Health (CDRH)
    Division of Bioresearch Monitoring:
    Donna Headlee, HFZ-310
    240-276-0125, FAX 240-276-0128

    Center for Food Safety and Applied Nutrition (CFSAN)
    Senior Science and Policy Staff:
    John Welsh, Ph.D., HFS-205
    301-436-1292, FAX 301-436-2972

  4. For crosscutting questions about Good Clinical Practice (GCP) policy and program issues impacting the Agency's BIMO Programs for GCP or HSP, contact:

    Office of Good Clinical Practice
    Office of Special Medical Programs
    Food and Drug Administration
    10903 New Hampshire Avenue., WO032-5103
    Silver Spring, MD 20993
    301-796-8340, FAX 301-827-1169
    gcp.questions@fda.hhs.gov

  5. For information about inspection warrants and final issuance of Notice of Opportunity of Hearing (NOOH) letters for clinical investigator disqualifications, contact:

    Office of Regulatory Affairs
    Office of Enforcement (OE)
    Director, Division of Compliance Management and Operations (HFC-210)
    240-632-6862, FAX 240-632-6859