Compliance Program 7348.809 - Part VI - References, Attachments, and Program Contacts

1. REFERENCES

1. FDA Laws
   
   Federal Food, Drug, and Cosmetic Act (FD&C Act)
   
    

2. Most Relevant 21 CFR Regulations
   
   

   Part 50	Protection of Human Subjects
   Part 56	Institutional Review Boards
   Part 312	Investigational New Drug Application
   Part 812	Investigational Device Exemptions

    

3. Other 21 CFR Regulations
   
   

   Part 11	Electronic Records; Electronic Signatures,
   Part 814	Premarket Approval of Medical Devices (includes HDE Requirements in 814.100)
   Part 320	Bioavailability and Bioequivalence Requirements

   
    

4. FDA Guidelines, Guidances, and Inspection Guides
   
    

• Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRB—Improving Human Subject Protection (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf)
  
   
• Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf)
  
   
• Guidance for Industry: IRB Review of Stand-Alone HIPPA Authorizations Under FDA Regulations (http://www.fda.gov/downloads/RegulatoryInformation/sGuidances/UCM126952.pdf)
  
   
• FDA Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors (http://www.fda.gov/oc/ohrt/irbs/default.htm)
  
   
• Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors: Process for Handling Referrals to FDA under 21 CFR 50.54 – Additional Safeguards for Children in Clinical Investigations (Guidances > Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations) 
  
   
• Guidance for Industry: International Conference on Harmonization (ICH) E6, Good Clinical Practice:  Consolidated Guidance (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.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 IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf)
  
   
• Humanitarian Device Exemption (HDE) Regulation: Questions and Answers; Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators and FDA Staff (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf)
  
   
• Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors —Frequently Asked Questions About Medical Devices (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf)
  
   
• Investigations Operational Manual (IOM) (http://www.fda.gov/ICECI/Inspections/IOM/default.htm)
  
   
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm)
  
   
• 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:  Using a Centralized IRB Review Process in Multicenter Clinical Trials (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127013.pdf)
  
   
• Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors -- Significant Risk and Nonsignificant Risk Medical Device Studies (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf)
  
   

2. 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 Domestic Field Investigations:
   301-796-5403, FAX 301-827-4090
   
    
3. For questions about GCP and Compliance program issues, specific to a Center product area, contact:
   
   Center for Drug Evaluation and Research (CDER)
   Office of Scientific Investigations:
   301-796-3399, FAX 301-847-8748
   
   Center for Biologics Evaluation and Research (CBER)
   Bioresearch Monitoring Staff:
   301-827-6221, FAX 301-827-6748
   
   Center for Devices and Radiological Health (CDRH)
   Division of Bioresearch Monitoring:
   301-796-5490, FAX 301-847-8136
   
   Center for Food Safety and Applied Nutrition (CFSAN)
   Office of Food Additive Safety;
   Division of Petition Review
   240-402-1265, FAX 301-436-2972
   
    
4. For crosscutting questions about GCP policy and program issues impacting the Agency’s BIMO Programs, or suggestions to improve this compliance program, contact:
   
   Office of Good Clinical Practice
   Office of Special Medical Programs
   Office of the Commissioner
   301-796-8340, FAX 301-847-8640