Description
This GCP Training: ICH E6(R2) course covers key components of the GCP requirements for clinical trials, found in ICH E6(R2), and relates to the roles and responsibilities of the investigator, sponsor, and other stakeholders. The course covers an introduction to GCP; reviews major regulatory agencies in the United States, European Union, and Japan; describes essential documentation methods; and moves on to cover good documentation practices (GDocP), including ALCOA-C.
Recommended for those new to working with GCP such as clinical research professionals who are in need of a more comprehensive GCP training to better understand the guidelines and to continue growing their career working on clinical trials.
This ICH E6 (R2) GCP Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training
identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
