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
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/

African Communication Resources

 Global Health Trials website

http://globalhealthtrials.tghn.org/regional-faculties/

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

 WHO/TDR Workbook for Investigators

http://whqlibdoc.who.int/hq/2002/TDR_PRD_GCP_02.1b.pdf

 WHO/TDR Standard Operating Procedures for Clinical Investigators

http://apps.who.int/tdr/svc/publications/tdr-research-publications/standard-operating-
procedures-for-clinical-investigators

International GCP Resources

 International Conference on Harmonisation (ICH) Homepage

http://www.ich.org/

 ICH-GCP Efficacy Guidelines

http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

European ICH Resources

 ICH Guideline on Good Clinical Practice (CPMP/ICH/135/95) (E6)

http://www.ema.europa.eu/ema/index.jsp?
curl=pages/includes/document/document_detail.jsp?
webContentId=WC500002874&murl=menus/document_library/document_library.jsp&mid
=WC0b01ac058009a3dc

 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/

 National competent authorities (human)

http://www.ema.europa.eu/ema/index.jsp?
curl=pages/medicines/general/general_content_000155.jsp&murl=menus/partners_and_n
etworks/partners_and_networks.jsp&mid=WC0b01ac0580036d63

 European Commission – Medicinal Product for Human Use

http://ec.europa.eu/health/human-use/index_en.htm

 EudraLex - Volume 1, Pharmaceutical Legislation Medicinal Products for Human Use

eg translations of the Directives 2001/20/EC and 2005.28/EC on clinical trials
http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm

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

Detailed Guidance documents
http://ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm

 EudraLex - Volume 3, Scientific guidelines for medicinal products for human use
http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm

 EudraLex - Volume 4, Good manufacturing practice (GMP) Guidelines - Annex 13,

Manufacture of investigational medicinal products 2003
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

 EudraLex - Volume 9, Pharmacovigilance guideline. Volume 9A: (2008)

http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm

UK Resources

 Medicines and Healthcare products Regulatory Agency (MHRA) – British Regulatory

Autority
http://www.mhra.gov.uk/index.htm

 UK Department of Health (DH)

http://www.dh.gov.uk/

 DH and MRC Clinical Trials Tool Kit

http://www.ct-toolkit.ac.uk/

 Data and Tissues Tool Kit

http://www.dt-toolkit.ac.uk/home.cfm

 Experimental Medicine Tool Kit

http://www.em-toolkit.ac.uk/home.cfm

 National Research Ethics Service (NRES) - comprises the former COREC and RECs
http://www.nres.npsa.nhs.uk/

 The Institute of Clinical Research (ICR)

http://www.icr-global.org/

 Records management: NHS code of practice

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuid
ance/DH_4131747

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US Resources

 US Food and Drug Administration (FDA)

http://www.fda.gov/

 US Guidances (Drugs)
http://www.fda.gov/cder/guidance/

 US Clinical / Medical guidance

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064
981.htm

 US National Institutes of Health (NIH)

http://www.nih.gov/

 US Office of Human Subjects Research (OHSR)

http://ohsr.od.nih.gov/index.html

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

http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121

 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 Ethics and Research Governance

http://www.mrc.ac.uk/Newspublications/Publications/Ethicsandguidance/index.htm

 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

 MRC Personal Information in Medical Research (2000)

http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002452

 MRC - Personal Information in Medical Research (2000) – Executive Summary

http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002453

 MRC Policy on data sharing and preservation

http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Datasharinginitiative/Policy/M
RC002551#P16_1349

 MRC Clinical research boosting African health (2006)

http://www.mrc.ac.uk/Newspublications/News/MRC001713

Journal Resources

 Applied Clinical Trials

http://www.actmagazine.com

 Consolidated Standards of Reporting Trials (CONSORT)

http://www.consort-statement.org/

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 Trials
http://www.trialsjournal.com/

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