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 1 |
Introduction to GCLP |
Module 2 |
Organisation & Personnel |
Module 3 |
Facilities, Equipment, Materials & Reagents |
Module 4 |
Standard Operating Procedures & Analytical Plan |
Module 5 |
Method and System Validation |
Module 6 |
Quality Management |
Module 7 |
Sample 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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