Resources: Reference LibraryGlossary

Course Overview

Duration:
This short course should take 60 - 120 minutes to complete.

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

Prerequisite:

ICH Good Clinical Practice

Background:
The Global Health Clinical Consortium (GHCC) is comprised of clinical operations leaders from 14 Product Development Partners (PDPs). These organisations are conducting ~125 ongoing and planned trials to develop vaccines, microbicides/preventatives, therapeutic products and diagnostics covering more than 20 disease areas at more than 260 clinical research sites in resource-limited settings. The GHCC functions as a platform to share learnings and pool resources to leverage expertise across PDPs. This course was developed in collaboration with The Global Health Network, using existing training already in use at PDP organisations. A mini-Working Group comprised of technical experts and non-technical reviewers from several of the PDPs developed this eLearning course. This course has also been reviewed by three technical peer reviewers.    

Summary:
Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analyses of samples from clinical trials while ensuring the purpose and objectives of the Good Clinical Practice principles are maintained. In so doing, the reliability, quality, consistency and integrity of data generated by clinical trial laboratories can be assured which is crucial to the outcome of any clinical trial. Introduction to Good Clinical Laboratory Practice is a stand-alone short course for all those wanting to gain an understanding of GCLP and its application in laboratories. This peer reviewed course provides an introduction to GCLP, summarises the principles of GCLP and offers an overview of the implementation of GCLP within a clinical trial.

Objectives: 
Upon successful completion of this course, you should be able to:

  • describe the differences between Good Clinical Practice, Good Laboratory Practice and Good Clinical Laboratory Practice guidelines
  • identify how GCLP compliance benefits laboratories
  • know the principles of GCLP and understand the requirements of each principle
  • identify how GCLP is implemented across the whole clinical trial process 
  • understand how GCLP guidelines could be interpreted and implemented in your laboratory

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the Bill and Melinda Gates Foundation (http://www.gatesfoundation.org/), the World-Wide Antimalarial Resistance Network (www.wwarn.org) and The East African Consortium for Clinical Research (www.eaccr.org).

Authors:

Carmelita Africa - Clinical Project Associate, International Partnership for Microbicides. Web

Liam Boggs - Training Manager, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford. Web

Paramesh Chetty - Senior Manager,Clinical Laboratory Programme - Africa, International AIDS Vaccine Initiative (IAVI). Web

Rhea Coler - MSc, PhD, VP, Preclinical Biology, Infectious Disease Research Institute (IDRI). Web

Andries Engelrecht - Quality Management & Compliance Specialist, International Partnership for Microbicides. Web

Sebastian Gelderbloem Managing Director, Aeras Africa. Web

Lakshmi Jayashankar - Senior Scientific Officer, Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD. Web

Wendy Keller - Quality Assurance Manager, DNDi - Drugs for Neglected Diseases initiative. Web

Maureen Power - PATH Vaccine Solutions. Web

Reviewers:

Hannelie Carstens, PhD - Director Quality Management and Compliance, International Partnership for Microbicides

Maureen Lambrick - Sr. Manager Lab Development Services, Tuberculosis, Aeras Africa

Motiur Rahman, MBBS, PhD - Head of Laboratories, Centre for Tropical Medicine, Oxford University Clinical Research Unit, HO CHi Minh City, Vietnam

Use and reproduction of these e-learning 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.

Resources: Reference LibraryGlossary

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