Course Overview

We are pleased to announce that as of June 1st 2017 this course has been updated to incorporate additional information from the latest International Conference on Harmonisation E6 (R2) Guidelines for GCP and re-named ‘ICH Good Clinical Practice E6 (R2)’ to reflect this update. Please take the revised version of this course for the latest updates and to gain the required certification.

Duration:

This course should take on average 45 - 60 minutes to complete

Certification:

A certificate is issued once a minimum of 80% is achieved in the final quiz section.

Summary:

Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.

Objectives:

Upon completion of this course, you will have an understanding of:

  1. What Good Clinical Practice (GCP) is
  2. The basic principles of GCP
  3. What being ‘GCP’ qualified means and why conducting a study according to GCP is important
  4. The responsibilities of the investigator
  5. How GCP should be adopted in the conduct of clinical research

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the Bill and Melinda Gates Foundation, the World-Wide Antimalarial Resistance Network and the East African Consortium for Clinical Research.  

Editors:

  • Mary Logan - Global Health Network Training Manager
  • Liam Boggs - Global Health Network Training Manager
  • Lauren Whelan - Global Health Network Training Assistant
  • Felicity Baka - Global Health Network Training Assistant

Reviewers:

  • Steve Wandiga - Kenya Medical Research Institute (KEMRI)/Centers for Disease Prevention and Control (CDC) - KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya.
  • Andy Burke - CTSU, Oxford University

Funders:

This module has been funded by the WorldWide Antimalarial Resistance Network (WWARN).

Source Material:

This course is based on material very kindly supplied by the MRC Unit, The Gambia, from their taught course ‘Good Clinical Practice’.

Use and reproduction of these elearning materials:

These e-learning materials are owned by The Global Health Network. You are free to share or adapt this material but you must attribute it to The Global Health Network using the link www.theglobalhealthnetwork.org.

The Following translations do not currently include the E6 (R2) update: 

 

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