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Helpful URLs

NCI CIRB

  • About the CIRB, SOPs, Quickguides
     
  • Institution, Network, Board Member Instructions

Cancer Therapy Evaluation Program (CTEP)

http://ctep.cancer.gov/

  • Information on the NIH CTEP Program, policies
  • Investigator Resources, Protocol Development
  • Information on Phase 3 trials under CTEP

Office for Human Research Protections (OHRP)

www.hhs.gov/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)

www.primr.org

  • Conferences and Webinars on Protection of Human Subjects
  • Timely information on industry trends and developments.

The Institutional Review Board (IRB) – Discussion and News Forum

www.irbforum.org

  • Various news articles
  • Questions and Answers on IRB-Specific topics.