Introduction to GCLP is now available from the Global Health Training Centre, click here to get started!
Good Clinical Laboratory Practice (GCLP) is a set of guidelines describing 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.
GCLP guidelines have been available since 2003 with face to face training in GCLP available from various organisations and institutions. However, a free, online, open access training course for GCLP that is available to all does not exist!
The 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 is based on existing training materials already in use at PDP organisations and developed by a mini-Working Group comprised of technical experts and non-technical reviewers from several of the PDPs including; International Partnership for Microbicides, International AIDS Vaccine Initiative (IAVI), Infectious Disease Research Institute (IDRI), Aeras Africa, Drugs for Neglected Diseases initiative (DNDi), PATH Vaccine Solutions.
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. It takes between 45 – 60 minutes to complete with a certificate issued upon successful completion of the final quiz.
This Introductory course is also the first module in a series of modules that will combine to form an in-depth, advanced Good Clinical Laboratory Practice Course. This multi-module course will cover each principle of GCLP in more depth, expand on the implementation of each principle and describe in detail how this can be achieved in all laboratory settings. Good Clinical Laboratory Practice will be launched later in 2015. Be sure to keep checking back at our course list to see newly released courses.