Good Clinical Practice 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
  • African Malaria Network Trust off free web-based training on Basic Health Research Ethics (in English and French) and Good Clinical Practice

African Communication Resources

  • Global Health Trials website

WHO Resources

  • WHO: Operational Guidelines for Ethics Committees That Review Biomedical Research (2000)also available in e.g. French and Portuguese
  • WHO/TDR: Ethical challenges in study design and informed consent for health research in resource-poor settings (2007)

WHO/TDR Workbook for Investigators

  • WHO/TDR Standard Operating Procedures for Clinical Investigators

International GCP Resources

  • International Conference on Harmonisation (ICH) Homepage
  • ICH-GCP Efficacy Guidelines

European ICH Resources

  • ICH Guideline on Good Clinical Practice (CPMP/ICH/135/95) (E6)
  • ICH Guideline on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95) (E3)

European Resources

  • European Medicines Agency (EMEA) - European Regulatory Authority
  • National competent authorities (human)
  • European Commission –Medicinal Product for Human Use

EudraLex - Volume 1, Pharmaceutical Legislation Medicinal Products for Human Useeg translations of the Directives 2001/20/EC and 2005.28/EC on clinical trials

EudraLex - Volume 10, Clinical trials guidelines - including translations of the Detailed Guidance documents

  • EudraLex - Volume 3, Scientific guidelines for medicinal products for human use
  • EudraLex - Volume 4,Good manufacturing practice (GMP) Guidelines - Annex 13, Manufacture of investigational medicinal products 2003
EudraLex - Volume 9, Pharmacovigilance guideline. Volume 9A: Pharmacovigilance for Medicinal Products for Human Use (2008)

UK Resources

  • Medicines and Healthcare products Regulatory Agency (MHRA) – British Regulatory Autority
  • UK Department of Health (DH)
  • DH and MRC Clinical Trials Tool Kit
  • Data and Tissues Tool Kit
  • Experimental Medicine Tool Kit
  • National Research Ethics Service (NRES) - comprises the former COREC and RECs
  • The Institute of Clinical Research (ICR)
  • Records management: NHS code of practice

US Resources

  • US Food and Drug Administration (FDA)

US Guidances (Drugs)

US Clinical / Medical guidance

  • US National Institutes of Health (NIH)
  • US Office of Human Subjects Research (OHSR)

Code of Federal Regulations (CFR) Title 21, Foods and Drugs

  • Code of Federal Regulations (CFR) Title 45, Part 46 Protection of Human Subjects (2005)

MRC Resources

  • MRC Ethics and Research Governance
  • MRC - Human Tissue and Biological Samples for use in Research - Operational and Ethical guidelines (2001)
  • MRC Policy and Procedure for Inquiring into Allegations of Scientific Misconduct (2009)
  • MRC Personal Information in Medical Research (2000)
  • MRC - Personal Information in Medical Research (2000) – Executive Summary
  • MRC Policy on data sharing and preservation
  • MRC Clinical research boosting African health (2006)

Journal Resources

  • Applied Clinical Trials
  • Consolidated Standards of Reporting Trials (CONSORT)
  • Trials

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