Introduction to Good Clinical Laboratory Practice

0 STUDENTS ENROLLED

    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 assure 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

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