Resources: Reference libraryGlossary

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:

  1. ICH Good Clinical Practice

  2. Introduction to Good Clinical Laboratory Practice

  3. GCLP: Organisation & Personnel

  4. GCLP: Facilities, Equipment, Materials & Reagents

  5. GCLP: Standard Operating Procedures & Analytical Plan

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:

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 Foundationthe World-Wide Antimalarial Resistance Network and The East African Consortium for Clinical Research.

Authors: 

Marci Aderiye Associate Director, Regulatory Affairs, Aeras. 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

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 libraryGlossary

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