Resources & Downloads

Documents and guidelines to download:

South African Good Clinical Practice Guideline (SA GCP 3rd edition 2020)

ICH Topic E6 (ICH GCP R2 2016)

WMA Declaration of Helsinki version 2013

Ethics in Health Research: Principles, processes and structures (SA Department of Health 2015)

Useful links:

http://www.sanctr.gov.za/ South African National Clinical Trial Register

http://www.pactr.org/ Pan African Clinical Trial Registry

http://www.nhrec.org.za/ National Health Research Ethics Committee

http://www.cioms.ch/ Council of International Organizations of Medical Science

https://www.ctnbestpractices.org/ Clinical Trials Networks Best Practices

http://www.abpi.org.uk/our-work/library/guidelines/Pages/default.aspx ABPI Guidelines

http://ohsr.od.nih.gov/guidelines/belmont.html The Belmont Report

http://www.mrc.ac.za/ethics/ethics.htm MRC Ethics Guidelines

http://www.sacraza.com/ : South African Clinical Research Association

https://globalhealthtrials.tghn.org/ : Global Health Trials