This page collects together resources about reviewing, training and inspecting GCP in international research. Please email us on info@globalhealthreviewers.org with any suggestions for further additions.
Online resources from regulatory agencies and other stakeholders
The European Medicine’s Agency resources on international research include an overview of patient recruitment and the geographical location of investigator sites around the world and a reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU regulatory authorities. Presentations from Africa and Asia about conducting GCP Inspections at the the EU GCP Inspectors Working Group Workshop in November 2012 are also available.
The European Forum for Good Clinical Practice has a number of resources including a report on Ethical Review of Protocols for Clinical Research Projects in the Europe and Beyond
The US Food and Drug Administration website has a comprehensive section on its International Programmes including details of its permanent in-country presence in China, India, Europe, Latin America, Middle East and North Africa, and Sub-Saharan Africa.
The UK’s Medicines and Healthcare products Regulatory Agency website has a comprehensive section on GCP.
The Danish Health and Medicines Authority website has useful resources on GCP Inspection.
The UK National Institute of Health Research’s Clinical Research Network has produced a 162 page compilation of GCP resources. While primarily focused on the UK, many of the resources are of broader relevance and interest.
Online training courses on Good Clinical Practice
Following are links providers of self-paced online training courses on GCP and GMP. If you go to our eLearning Directory you can find further details about the languages the courses are available in, as well as costs and whether certification is offered.
Epigeum UK – Good Clinical Practice
Global Ethics Education Initiative (GEEI)/MERETI - Essentials of Good Clinical Practice
Global Health Training Centre -ICH Good Clinical Practice Course
Society of Clinical Research Associates - cGMP for Investigational New Drugs in Phase I Clinical Trials and What you should know before the FDA Arrives
Training and resources in research ethics evaluation for Africa (TRREE) Good Clinical Practice
U.S. Department of Health and Human Services Ethical and regulatory aspects of clinical research
University of London, Infonetica Ltd. Good Clinical Practice
International Guidance on GCP
IInternational Conference on Harmonization (ICH)
E6 Good Clinical Practice: Consolidated Guidance (1996)
WHO Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2002)
For national guidance on GCP please search for the relevant county in the 2013 OHRP International Compilation of Human Research Standards or visit the Global Health Regulatory Requirements Database.
Join the conversations
There are discussion threads about ICH GCP, and GCP training and a blog post on experiences of GCP training at our sister site, Global Health Trials. Please use the search function at the top right hand corner to find further resources on GCP on the Global Health Network sites. One recent article focuses on Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice.