Graeme Downes, Senior Director, Clinical and PV QA, AstraZeneca
Anatoly Gorkun, Senior Manager, Scientific and Compliance Training, MedImmune
Abstract: The Good Clinical Practice (GCP) regulations require that each individual involved in conducting a clinical trial be qualified by education, training, and experience to perform the respective tasks. This article provides an overview of the purpose of GCP training, ways of delivering GCP training, and components of the GCP training package. An effective way to build a risk-based GCP training program is described.
Disclaimer: The views and opinions presented here are those of the authors and not of MedImmune or AstraZeneca.
GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global. For example, in the United Kingdom, regulation 28 of the UK SI 2004/1031 states that, “no person shall conduct a clinical trial… otherwise than in accordance with the conditions and principles of GCP.” From a global perspective, the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice §2.8. states: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” This means that each individual involved in conducting a clinical trial must receive training in GCP.
Even though legislative requirements have been in effect for several years and most if not all companies claim to have GCP training programs in place, non-compliance with GCP is frequently identified, as evidenced through monitoring, audit, and inspection findings.
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