good clinical laboratory practice free online course

Last Updated on December 14, 2022 by Omoyeni Adeniyi

Good Clinical Laboratory Practice course is a mandatory and essential training for any clinical laboratory technician related to the Health and Medical industry. This free online course can be taken by physicians, lab technicians, biochemists, pathology assistants and other healthcare workers related to lab work.

Good Clinical Laboratory Practice

About this Course

The Global Health Clinical Consortium (GHCC) is comprised of clinical operations leaders from 14 Product Development Partners (PDPs). These organisations are conducting ~125 ongoing and planned trials to develop vaccines, microbicides/preventatives, therapeutic products and diagnostics covering more than 20 disease areas at more than 260 clinical research sites in resource-limited settings. The GHCC functions as a platform to share learnings and pool resources to leverage expertise across PDPs. This course was developed in collaboration with The Global Health Network, using existing training already in use at PDP organisations. A mini-Working Group comprised of technical experts and non-technical reviewers from several of the PDPs developed this eLearning course. Each module has also been reviewed by three technical peer reviewers.

Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analyses of samples from clinical trials while ensuring the purpose and objectives of the Good Clinical Practice principles are maintained. In so doing, the reliability, quality, consistency and integrity of data generated by clinical trial laboratories can be assure which is crucial to the outcome of any clinical trial. Good Clinical Laboratory Practice is a multi-module course for all those wanting to gain an in-depth understanding of GCLP and how each principle of GCLP can be applied in clinical trial laboratory.

How to get the most from the course

It is strongly suggested that each module is taken in numerical order as listed below and that all hyperlinks to additional information, resources and glossary terms are followed to gain the maximum amount of information from the course. Introduction to GCLP is designed to be an individual short course and is also the first module of this multi-module course. Because this course is still under development the modules will be released as they become available and a certificate of completion will be awarded for each individual module once a minimum of 80% is achieved in the module quiz sections. 

Prerequisite

ICH Good Clinical Practice

Course Contents

Module 1Introduction to GCLP
Module 2Organisation & Personnel
Module 3Facilities, Equipment, Materials & Reagents
Module 4Standard Operating Procedures & Analytical Plan
Module 5Method and System Validation
Module 6Quality Management
Module 7Sample Management, Conduct of The Work, Data Recording, and Data Reporting

Resources 

Reference library

Glossary

This peer reviewed course has been created by a team of experts from across the globe using donated training materials, referenced guidelines and articles and various other resources

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Introduction to Good Clinical Laboratory Practice

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ESPAÑOL PORTUGUÊS FRANÇAIS

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:
The Global Health Clinical Consortium (GHCC) is comprised of clinical operations leaders from 14 Product Development Partners (PDPs). These organisations are conducting ~125 ongoing and planned trials to develop vaccines, microbicides/preventatives, therapeutic products and diagnostics covering more than 20 disease areas at more than 260 clinical research sites in resource-limited settings. The GHCC functions as a platform to share learnings and pool resources to leverage expertise across PDPs. This course was developed in collaboration with The Global Health Network, using existing training already in use at PDP organisations. A mini-Working Group comprised of technical experts and non-technical reviewers from several of the PDPs developed this eLearning course. This course has also been reviewed by three technical peer reviewers.    

Summary:
Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analyses of samples from clinical trials while ensuring the purpose and objectives of the Good Clinical Practice principles are maintained. In so doing, the reliability, quality, consistency and integrity of data generated by clinical trial laboratories can be assured which is crucial to the outcome of any clinical trial. Introduction to Good Clinical Laboratory Practice is a stand-alone short course for all those wanting to gain an understanding of GCLP and its application in laboratories. This peer reviewed course provides an introduction to GCLP, summarises the principles of GCLP and offers an overview of the implementation of GCLP within a clinical trial.

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).

Authors:

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

Andries Engelrecht – Quality Management & Compliance Specialist, International Partnership for Microbicides. Web

Sebastian Gelderbloem – Managing Director, Aeras Africa. Web

Lakshmi Jayashankar – Senior Scientific Officer, Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD. Web

Wendy Keller – Quality Assurance Manager, DNDi – Drugs for Neglected Diseases initiative. Web

Maureen Power – PATH Vaccine Solutions. Web

Reviewers:

Hannelie Carstens, PhD – Director Quality Management and Compliance, International Partnership for Microbicides

Maureen Lambrick – Sr. Manager Lab Development Services, Tuberculosis, Aeras Africa

Motiur Rahman, MBBS, PhD – Head of Laboratories, Centre for Tropical Medicine, Oxford University Clinical Research Unit, HO CHi Minh City, Vietnam

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.

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Resources: Reference LibraryGlossary

Your feedback is greatly appreciated; please take a couple of minutes to tell us your thoughts on this course: 

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Good Clinical Laboratory Practice

Current StatusNOT ENROLLEDPrice££159Get StartedTake this Course

Download Course Summary Leaflet

Good Clinical Laboratory Practice (GCLP) was first drafted and published in 2003. Then in 2006, the World Health Organisation (WHO) published GCLP guidance on its website as the standard for laboratories undertaking samples from Clinical Trials.

GCLP guidance identifies the systems required and procedures to be followed within any organisation that conducts analysis of samples from Clinical Trials in compliance with the requirements of Good Clinical Practice (GCP).

This interactive and engaging GCLP course provides sponsors, laboratory management, project managers, CRAs and quality assurance personnel with an understanding of the framework for a quality system in analysis of clinical trial samples. It will ensure that all laboratory processes and results are GCLP compliant.

Learning Objectives

  • Briefly examine Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) to understand why they differ from Good
  • Clinical Laboratory Practice (GCLP)
  • Understand why GCLP is needed and how it was developed
  • Consider all the area the principles of GCLP cover including: 
  • Organisation and Personnel Facilities Equipment, materials and reagents Standard Operating Procedures (SOPs) Planning of the work Sub-contracting Trial materials Conduct of the work Reporting Quality Control (QC) and Quality Audit (QA) Storage and retention of records Confidentiality, blinding & participant safety.
  • Learn how to implement the principles of GCLP to ensure workplace compliance
  • Understand the contents of a clinical trial protocol and analytical plan, and learn how to create them to support GCLP compliance
  • Know how to collect, transport, receive and analyse samples effectively
  • Understand how to report, record and archive effectively according to GCLP expectations.

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Course Content

Course IntroductionModule 1 – Introduction to GCLPModule 2 – GCLP requirementsModule 3 – Practical implications of GCLPGCLP – Summary & Exam