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 composed 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 comprising 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. This module will focus on sample management, conduct of the work, data recording and data reporting.

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

  • Understand what we mean by data integrity and data governance
  • Identify the characteristics that data should possess to ensure data integrity
  • Understand the nature of the data lifecycle
  • Undertake data risk assessments

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). The Global Health Training Centre is the training platform for the Global Health Network.

Authors:

Alice Neequaye, Quality Manager, Medicines for Malaria Venture (MMV). Web

Reviewers:

Almari Conradie, Director, Clinical Operations, Global Alliance for TB Drug Development. Web

Helen Dell, Training Coordinator, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK Web

Helen Demarest, Associate Director, Clinical Operations, Medicines for Malaria Venture (MMV). Web

Kathryn Rutkowski, Director, Biostatistics and Data Management, International AIDS Vaccine Initiative (IAVI). Web

Liam Boggs, Senior Operations Manager, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK Web

Mahnaz Vahedi, Scientist, Research Capacity Strengthening Unit, Special Programme for Research and Training in Tropical Diseases (WHO TDR). Web

Mariette Malherbe, Clinical Support Manager, International Partnership for Microbicides (IPM). Web

Paramesh Chetty, Associate Director, Clinical Laboratory Programme, International AIDS Vaccine Initiative (IAVI). Web

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

Application Developers:

Kehkashan Shah, Training Assistant, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK Web

Lauren Whelan, Training Officer, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK Web

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 Library

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