Good Laboratory Practice: Clinical (English)

Good Clinical Laboratory Practice (GCLP) Training for Laboratories, Manufacturers and Suppliers of Pharmaceutical products. The Good Clinical Laboratory Practice (GCLP) course describes the standards to be followed by laboratories that perform analysis or evaluation of clinical trial samples. The GCLP rules were introduced because the GCP guidance contains insufficient detail to provide specific guidance to clinical laboratories. Updated May 2019. The course covers all aspects of GCLP from the setup and planning of the analytical lab (based on the type and quantity of samples to be processed), right through to the documentation and analysis itself. The author, Louise Handy, is Chair of the RQA (formerly BARQA), who published the original GCLP guidance that is now recognized worldwide.

Good Clinical Laboratory Practice (GCLP) is a crucial supplement to the broader GCP rules that govern clinical trials. The principles should be followed by all labs involved in analysing samples from clinical trials to ensure that the work is reliable, and ethical and can accurately be used to support the findings of the trial. This course is recommended for - lab managers, QA personnel, lab project managers, and other lab staff, plus senior management considering a move into clinical trials work within - clinical laboratories, university labs, pharmaceutical company labs, and hospital labs involved with clinical trials.