Skip to main content Skip to main site menu
Georgetown University.
Georgetown University.
Office of Research Oversight/Regulatory Affairs
Close the search box ×
  • Staff
  • Conflict of Interest
    • CMS Open Payments
    • COI Disclosure Requirements in Lectures at GUMC
    • File A Disclosure Form
    • FCOI Policies
    • FCOI Training
    • Approval of Extramural Activity
  • Clinical Trials Registration
    • Updates
  • Data Management
    • ORCID
  • Export Controls
    • Overview of Regulations
    • University Research and Export Controls
    • International Research Relationships and Activities
  • Institutional Animal Care and Use Committee
    • IACUC Committee Meeting
    • IACUC Guidelines, Policies and SOPs
    • IACUC Training Information
    • IACUC Forms
    • IACUC Guidelines for Investigators
    • IACUC Protocol Submission Guidelines
    • IACUC Reporting Animal Welfare Concerns
    • Regulations, Standards and Resources
    • IACUC Accreditation Information
    • IACUC DCM Formulary & Website Link
  • Institutional Review Board
    • IRB Updates and News
    • IRB 101
    • Georgetown-MedStar IRB System
    • eRIC (Decommissioned)
    • Training
    • Calendar & Meeting Schedules
    • IRB Committees: Information, Rosters, Etc.
    • Templates & Forms
    • Policies, Procedures, Manuals, Regulations, & Guidance
    • Student-conducted Research
    • Educational Opportunities, Programs, & Events
    • Federal Wide Assurance (FWA)
    • IRB Fees
    • Statistical & Bioinformatics Consultation Services
    • Report Research Compliance Complaint or Concern
    • Radiation Safety
  • Occupational Health
    • Announcements
  • Office of Research Quality Assurance
    • ORQA Staff
    • ORQA Auditing
    • Data and Safety Monitoring Committees (DSMC)
    • ORQA Policies and Resources
    • ORQA Training & Education
  • Research Integrity & Misconduct
    • Research Integrity Committee
  • Seminars & Education
    • RCR Training
  • Staff
  • Conflict of Interest
    • CMS Open Payments
    • COI Disclosure Requirements in Lectures at GUMC
    • File A Disclosure Form
    • FCOI Policies
    • FCOI Training
    • Approval of Extramural Activity
  • Clinical Trials Registration
    • Updates
  • Data Management
    • ORCID
  • Export Controls
    • Overview of Regulations
    • University Research and Export Controls
    • International Research Relationships and Activities
  • Institutional Animal Care and Use Committee
    • IACUC Committee Meeting
    • IACUC Guidelines, Policies and SOPs
    • IACUC Training Information
    • IACUC Forms
    • IACUC Guidelines for Investigators
    • IACUC Protocol Submission Guidelines
    • IACUC Reporting Animal Welfare Concerns
    • Regulations, Standards and Resources
    • IACUC Accreditation Information
    • IACUC DCM Formulary & Website Link
  • Institutional Review Board
    • IRB Updates and News
    • IRB 101
    • Georgetown-MedStar IRB System
    • eRIC (Decommissioned)
    • Training
    • Calendar & Meeting Schedules
    • IRB Committees: Information, Rosters, Etc.
    • Templates & Forms
    • Policies, Procedures, Manuals, Regulations, & Guidance
    • Student-conducted Research
    • Educational Opportunities, Programs, & Events
    • Federal Wide Assurance (FWA)
    • IRB Fees
    • Statistical & Bioinformatics Consultation Services
    • Report Research Compliance Complaint or Concern
    • Radiation Safety
  • Occupational Health
    • Announcements
  • Office of Research Quality Assurance
    • ORQA Staff
    • ORQA Auditing
    • Data and Safety Monitoring Committees (DSMC)
    • ORQA Policies and Resources
    • ORQA Training & Education
  • Research Integrity & Misconduct
    • Research Integrity Committee
  • Seminars & Education
    • RCR Training
Home ▸ Policies and Procedures Manual

Policies and Procedures Manual

Last Updated: February 2020

Table of Contents
Cover and Table of Contents
(6 pages)
Chapters 1-17
(83 pages)
Appendices
Appendix I – Ethics References
(21 pages)
Appendix II – Regulations and Standards:

  • II-A – FDA Informed Consent Regulations at 21 CFR Part 50
  • II-B – FDA Financial Disclosure by Clinical Investigators Regulations at 21 CFR Part 54
  • II-C – FDA IRB Regulations at 21 CFR Part 56
  • II-D – FDA Investigational New Drug Regulations at 21 CFR Part 312
  • II-E – FDA Biological Products Regulations at 21 CFR Part 600
  • II-F – FDA Investigational Device Regulations at 21 CFR Part 812
  • II-G –  PHS Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought Regulations at 21 CFR Part 54, Subpart F
  • II-H – DHHS Human Subject Regulations at 45 CFR Part 46
  • II-I – International Conference on Harmonisation – Guidelines on Good Clinical Practice [ICH-GCP]
  • II-J FDA Non-Significant and Significant Risk Device Examples
  • II-K DHHS/FDA Expedited Review List
Appendix III – Georgetown University Requirements
(12 pages)
Georgetown University seal.

Office of Research Oversight/Regulatory Affairs

37th and O Streets, N.W.

Washington DC

Phone: 202-687-0100

  • Maps
  • Copyright
  • Privacy
  • Accessibility
  • Notice of Non-Discrimination
  • Full Site Menu