Resources: Reference library, Glossary
Module Overview
Duration:
This module should take 40-60 minutes to complete
Certification:
A certificate is issued once a minimum of 80% is achieved in the final quiz section
GCLP: Method and System Validation is the fifth 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 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 for the selection and validation of the analytical methods to be used in the laboratory and the computer systems required by the laboratory to receive, capture, process and report clinical trial data. 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)
- Good Clinical Laboratory Practice (WHO GCLP 2009)
- Good Clinical Laboratory Practice (RQA GCLP 2012)
- Good Laboratory Practice (OECD GLP 1997)
Objectives:
Upon successful completion of this course, you should be able to:
- Identify the different types of analytical methods
- Understand the process involved in selecting an appropriate analytical method
- Know when the validation of a method should take place
- Identify and understand each step of the method validation process
- Define the verification and keyvalidation elements details for validation of bioanalyticalanalytical methods
- Identify computerised systems in a laboratory
- Define the required elements for validation of a computerised system
- Understand and develop user acceptance testing
- Ensure the integrity of clinical trial laboratory data through effective validation and operation of computerised systems and analytical methods
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.
Authors:
Marci Aderiye - Associate Director, Regulatory Affairs, Aeras.
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
Almari Conradie - Senior Clinical Operations Manager at Global Alliance for TB Drug Development. Web
Tracey Day - Ph.D. Scientist, Infectious Disease Research Institute (IDRI). Web
Helen Demarest - Associate Director, Clinical Operations, Medicines for Malaria Venture (MMV). Web
Sabine Dittrich - Senior Scientific Officer, Foundation for Innovative New Diagnostics (FIND). Web
Sebastian Gelderbloem - Global Health Laboratories Coordinator, The Global Health Network. Web
Lakshmi Jayashankar - PhD, Senior Scientific Officer, Columbus Technologies and Services, Contractor to National Institutes of Health, USA.
Wendy Keller - Quality Assurance Manager, DNDi - Drugs for Neglected Diseases initiative. Web
Amresh Kumar - Team Leader/Senior Medical Officer, PATH Web
Troy Leader - PhD, Scientific Program Officer, Diagnostics Global Program, PATH. Web
Alice Neequaye - Quality Officer, Medicines for Malaria Venture (MMV). Web
Mahnaz Vahedi - Special Programme for Research and Training in Tropical Diseases. Web
Reviewers:
Hannelie Carstens - Laboratory Consultant
John Parker - Director and Principal Consultant, ClinParkQA Ltd. web
Maureen Lambrick - Lab Consultant for Aeras
Motiur Rahman, MBBS, PhD - Head of Laboratories, Centre for Tropical Medicine, Oxford University Clinical Research Unit, HO CHi Minh City, Vietnam
Application developers:
Lauren Whelan - Training Assistant, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK Web
Felicity Baka - Training Assistant, 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, Glossary
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