GCP Training and CertificationAugust 1, 2013 2013-08-01 17:27
GCP Training and Certification
GCP training and certification :- GCP / ICH-GCP is an international ethical and scientific standard or guiding principles to start, execute, collect and report clinical research outcomes that involve humans as study volunteers. The fulfillment of these principles guarantees end users that the human subjects’ rights, safety and wellbeing are protected according to the principles laid down in the Declaration of Helsinki, and that the data collected and reported out of a clinical study are reliable and true.
The 13 core principles of ICH- GCP are applicable to all clinical research studies that could affect the safety and wellbeing of human subjects.
Good clinical practices in clinical research were transpired by the regulatory authorities of US, EU and Japan collectively by a path-finding committee termed the Tripartite International Conference on Harmonization (ICH) and came into being as ‘guidance to industry’ in 1997. The idea was to evolve at a common standard to make possible the mutual acceptance of clinical study data by the respective local regulatory authorities around the globe.
Clinical research professionals involved in any phase of clinical trial work need to be appropriately qualified to make sure that they comply with Good clinical practices. This is applicable to all concerned departments supporting the clinical trial endeavors. There are no customary qualifications required to get certified however it is obligatory to maintain timely records of GCP training and certification of the study personnel.