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:

GCLP: Quality Management is the sixth module of the Good Clinical Laboratory Practice (GCLP) course. The course is designed for all those wanting to gain an in-depth understanding of the Quality Management principles of GCLP, how each principle is applied in a clinical laboratory and the impact implementation of these principles has on the laboratory and the clinical trial. It is highly recommended that you complete the following short courses and modules on the Global Health Training Centre before starting this module:

Summary:
This module examines GCLP guidance on the requirements and implementation of quality management within the laboratory to ensure the quality and accuracy of all aspects of the work performed and reported. 

This module is based on the following guidelines and materials:

ICH Harmonised Guideline – Integrated Addendum to ICH E6(R2): Guideline for Good Clinical Practice (ICH GCP E6 R2 2016)

EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (Feb 2012)

Good Clinical Laboratory Practice (WHO GCLP 2009)

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). 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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