Investigational Drugs
Background
Institutional Review Boards
- IRB Guidebook
Office for Human Research Protections
U.S. Department of Health and Human Services
- Office for Human Research Protections
U.S. Department of Health and Human Services
- Office of Research Integrity
U.S. Department of Health and Human Services
- Research Integrity Officers
U.S. Department of Health and Human Services
- Books
- Kornetsky, Susan; Applied Research Ethics National Association.
Study Guide for Institutional Review Board : Management and Function
Sudbury, Mass. : Jones and Bartlett, c2003 - Dawson, John; Foley, Mary; Peart, Nicola
Research Ethics Commmittees
In: Law of Research : a guide
Dunedin, N.Z. : University of Otago Press, 2003. - Bankert, Elizabeth A; Amdur, Robert J; Amdur, Robert J
Institutional Rreview Board : Management and Function, 2nd ed.
Sudbury, Mass. : Jones and Bartlett, c2006.
- ECRI
Institutional Review Boards : Regulatory and Risk Management Overview
In: Healthcare Risk Control V. 2, Risk Analysis
Plymouth Meeting, Pa. : ECRI, c2005.
Rules, Regulations, and Guidance
- Rozovsky, F.A.; Adams, Rodney K
Clinical Trials and Human Research : A practical guide to regulatory compliance, 1st ed.
San Francisco : Jossey-Bass, 2003
- Code of Federal Regulations
- Title 21--Food and Drugs
Chapter I--Food and Drug Administration
Department of Health and Human Services
Subchapter A--General Part 50 Protection of Human Subjects
- Title 45 -- Public Welfare
Department of Health and Human Services
Part 46 Protection Of Human Subjects
- 1 CFR Part 210, [Docket No. 2005N–0285]
Food and Drug Administration, HHS.
Direct final rule.
Current Good Manufacturing Practice Regulation and Investigational New Drugs (PDF, 65 KB)
Federal Register / Vol. 71, No. 10 / Tuesday, January 17, 2006 / Rules and Regulations
- 1 CFR Part 312, [Docket No. 2000N–1663], RIN 0910–AA61
Food and Drug Administration, HHS.
Direct final rule
Investigational New Drugs: Export Requirements for Unapproved New Drug Products (PDF, 100 KB)
Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations
- 1 CFR Parts 201, 314, and 601,
[Docket No. 2000N–1269] (formerly Docket No. 00N–1269), RIN 0910–AA94
Food and Drug Administration
Final Rule
Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products (PDF, 65 KB)
Fed Register. 2006 Jan 24;71(15):3921-97
- Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
U.S. Food and Drug Administration - Guidances / Guidelines / Points to Consider
U.S. Food and Drug Administration
- HIPAA Privacy Rule and Its Impacts on Research
National Institutes of Health
- Historical Information
- Office for Human Research Protections (OHRP) Policy Guidance
U.S. Department of Health and Human Services
- Quick Reference Guide
Developmental Therapeutics Program National Cancer Institute
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