Good Clinical Practice is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.
The principles of 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 (for example, safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards, investigators, sponsors, and monitors.
GCP is not just for biomedical research. GCP also applies to behavioral research. Researchers and research team members involved in NIH-funded research that meets the definition of a clinical trial are required to complete GCP training.
Similar to Core IRB Training, the training completion is valid for three years. In addition to NIH, some sponsors require GCP training prior to funding or beginning research. All investigators should confirm what training courses an individual sponsor may require.
Even if you are not conducting a clinical trial, the principles and concepts of GCP can be applied to your research to improve the quality and compliance of the research.
Two training options are listed below. However, they may not meet the requirements for FDA-regulated research. Discuss with OPRS before completing the training.
If your sponsor or funding agency requires GCP training, confirm with OPRS before taking a training that is not listed below.
This is the National Institutes of Health (NIH) training and certification for good clinical practice in social and behavioral research. Effective January 1, 2017, all NIH-funded investigators and staff who are involved in applying for, conducting, overseeing, or managing clinical trials may be required to show documentation of training completion.
The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners.