NCI CIRB
- About the CIRB, SOPs, Quickguides
- Institution, Network, Board Member Instructions
Cancer Therapy Evaluation Program (CTEP)
- Information on the NIH CTEP Program, policies
- Investigator Resources, Protocol Development
- Information on Phase 3 trials under CTEP
Office for Human Research Protections (OHRP)
- Topic-specific references, Guidance Documents, FAQs, and DHHS Regulations.
Food and Drug Administration (FDA)
www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
- Topic-specific references, Guidance Documents, FAQs, and FDA Regulations.
U.S. Department of Health and Human Services (DHHS) Regulations
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- 45 CFR 46
FDA Regulations
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm
- 21 CFR 50
- 21 CFR 56
Public Responsibility in Medicine and Research (PRIM&R)
- Conferences and Webinars on Protection of Human Subjects
- Timely information on industry trends and developments.
The Institutional Review Board (IRB) – Discussion and News Forum
- Various news articles
- Questions and Answers on IRB-Specific topics.