Faculty and Staff Resources

Human Research Protections Office (HRPO)

General Clinical Research Center (GCRC)

Office of Research and Development (ORD)

School of Medicine, Office of Research Affairs

(EHS)

ICH E6 Good Clinical Practice: The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants.

Good Clinical Practice in FDA-Regulated Clinical Trials

NIH e-learning course: Good Clinical Practice for Social and Behavioral Research

FDA (Food and Drug Administration)

NIH (National Institutes of Health)

OHRP (Office of Human Research Protection)

VA (Veterans Affairs)

CMS (Centers for Medicare and Medicaid Services)

OIG (Office of the Inspector General)

ORI (DHHS Office of Research Integrity)

ORO (Office of Research Oversight-Veterans Affairs)

Code of Federal Regulations: 45 CFR Part 46

The Belmont Report

Veterans Affairs: Current ORD Policy Documents

FDA Regulations: 21 CFR:

• Part 11 — Electronic Records; Electronic Signatures
• Part 50 — Protection of Human Subjects
• Part 54 — Financial Disclosure by Clinical Investigators
• Part 56 — Institutional Review Boards
• Part 312 — Investigational New Drug Application (IND)
• Part 314 — Applications for FDA Approval to Market a New Drug (NDA)
• Part 600 — Biological Products
• Part 812 — Investigational Device Exemptions

AAHRPP (Association for the Accreditation of Human Research Protections Programs)

AAMC Medical Research

PRIM&R (Public Responsibility in Medicine & Research)

The Hastings Center

ACRP (Association of Clinical Research Professionals)

SOCRA (The Society of Clinical Research Associates)

NIH Bioethics Resources

Clinical Trials.gov

Centerwatch

Certificates of Confidentiality

FDA Information Sheets