Resources: Reference Library, Glossary
This short course should take 60-120 minutes to complete.
A certificate is issued once a minimum of 80% is achieved in the final quiz section.
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:
- ICH Good Clinical Practice
- Introduction to Good Clinical Laboratory Practice
- GCLP: Organisation & Personnel
- GCLP: Facilities, Equipment, Materials & Reagents
- GCLP: Standard Operating Procedures & Analytical Plan
- GCLP: Method & Systems Validation
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:
Good Clinical Laboratory Practice (WHO GCLP 2009)
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
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.
Alice Neequaye, Quality Manager, Medicines for Malaria Venture (MMV). Web
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
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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