Resources: Reference library, Glossary

Module Overview

Duration:
This module should take 60-120 minutes to complete

Certification:
A certificate is issued once a minimum of 80% is achieved in the final quiz section

GCLP: Standard Operating Procedures and Analytical Plan is the fourth 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

Summary:

This module provides a detailed analysis of GCLP guidance for the planning of the work to be conducted in the clinical trial laboratory and covers the documentation required to detail the work conducted in the analysis of participant samples, namely the analytical plan and standard operating procedures (SOPs). This module is based on the following guidelines and materials:

Objectives:

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

  • Explain the relationship between the clinical trial protocol, the analytical plan and standard operating procedures.
  • Establish high quality standard operating procedures which will ensure quality and integrity of the data produced in the laboratory
  • List and define the components of an SOP
  • Establish a system for SOP development
  • Understand the function and purpose of the analytical plan 
  • Develop an analytical plan for a clinical trial in your laboratory

Acknowledgements

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. Web

Carmelita Africa - Clinical Project Associate, International Partnership for Microbicides. 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

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 - Managing Director, Aeras Africa. 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

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:

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:

Felicity BakaTraining 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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