GCP Training :- Good Clinical Practice (GCP) is a worldwide quality norm implemented by the International Conference on Harmonization (ICH), which elucidates the standards to follow for the proper conduct of clinical research. It delineates the roles and responsibilities of the different stakeholders’ viz., sponsors, investigators, ethics committees and others involved for the protection of human rights as subjects of clinical studies.
Clinical trials should be conducted in compliance with the ethical principles that have their basis in the Declaration of Helsinki, and that are in agreement with GCP and the applicable local regulatory requirements. The ICH-GCP is having a major role in the globalization of clinical research endeavors, since clinical trial data generated in one region is in compliance with ICH-GCP can be potentially used to file a new drug application in other regions.
The training and certification are mandatory to take-up or participate in a clinical study. James Lind Institute’s’ GCP training is a collection of the global ICH-GCP guidelines for the conduct of clinical trials. It offers access to the guidelines in a well-versed manner and in an understandable way reads the global ICH-GCP guidelines, which have been followed by local regulatory bodies of the countries around the World. It will help you comprehend step-by-step process of how to conduct a clinical study with ICH-GCP guidelines as a back drop.