NIH issued a policy, effective January 1, 2017, establishing the requirement that all investigators and staff involved in the conduct, oversight, or management of NIH funded clinical trials must be trained in Good Clinical Practice (GCP).
The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.
Training Information & Resources
GCP training can be completed through the CITI Program: https://www.citiprogram.org