Professional Documents
Culture Documents
GCP Resources Web Links
GCP Resources Web Links
Training Resources
Family Health International (FHI) –provides technical and research services and Free
Research Ethics Training Curriculum also in French, Spanish and Portuguese
http://www.fhi.org/en/index.htm
African Malaria Network Trust off free web-based training on Basic Health Research Ethics
(in English and French) and Good Clinical Practice
http://webcourses.amanet-trust.org/
WHO Resources
WHO: Operational Guidelines for Ethics Committees That Review Biomedical Research
(2000) also available in e.g. French and Portuguese
http://www.who.int/tdr/publications/publications/pdf/ethics.pdf
WHO/TDR: Ethical challenges in study design and informed consent for health research in
resource-poor settings (2007)
http://www.who.int/tdr/publications/publications/pdf/ethical_challenges.pdf
ICH Guideline on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95) (E3)
http://www.ema.europa.eu/ema/index.jsp?
curl=pages/includes/document/document_detail.jsp?
webContentId=WC500002832&murl=menus/document_library/document_library.jsp&mid
=WC0b01ac058009a3dc
European Resources
European Medicines Agency (EMEA) - European Regulatory Authority
http://www.emea.europa.eu/
EudraLex - Volume 3, Scientific guidelines for medicinal products for human use
http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm
UK Resources
National Research Ethics Service (NRES) - comprises the former COREC and RECs
http://www.nres.npsa.nhs.uk/
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US Resources
US Guidances (Drugs)
http://www.fda.gov/cder/guidance/
Code of Federal Regulations (CFR) Title 45, Part 46 Protection of Human Subjects (2005)
http://ohsr.od.nih.gov/guidelines/45cfr46.html
MRC Resources
MRC - Human Tissue and Biological Samples for use in Research - Operational and Ethical
guidelines (2001)
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002420
MRC Policy and Procedure for Inquiring into Allegations of Scientific Misconduct (2009)
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC005820
Journal Resources
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Trials
http://www.trialsjournal.com/
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