Good Clinical Practice (GCP) Certification :- Good Clinical Practice (GCP) is a global scientific quality and ethical standard for scheming, conducting, collecting and reporting of clinical study data that engage human subjects.
Approximately every phase of pharmaceutical drug development is subjected to scrutiny and since many years it has been an obligation for regulatory authorities to see that clinical trials are performed and conducted in compliance with Good Clinical Practice (GCP). Therefore all the key personnel like Principal Investigators, sub-investigators, clinical research associates, clinical research coordinators, research nurses and others associated within the industry should have sound knowledge in ICH-GCP. Majority of pharmaceutical companies provide ICH-GCP training for their work force either in-house or from outside sources.
Mere understanding of ICH-GCP is not sufficient but a documented certification from a proper certifying body or a training institute is asked for by sponsors’ for all staff members participating in a clinical study at any capacity or level. The accountability for GCP is shared by all of the players involved, including sponsors, contract research organizations (CROs), investigators and trial site staff, regulatory authorities, and ethics committees.
James Lind Institute offers online GCP training and certification program. It is for all personnel involved in the conduct of clinical studies including clinical research scientists, research nurses, and technicians as well as clinicians.