What is GCP?
Good Clinical Practice (GCP) is an international quality standard for conducting clinical trials that is provided by the International Conference on Harmonization (ICH), an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
Who Needs GCP Training?
Effective January 1, 2017 – NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP). Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.
What are my Training Options?
The NIH policy does not require a particular GCP course or program. Training in GCP may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. NIH also offers GCP training that is free of charge, including options from NIAID, NIDA, and NCATS. Other free courses as well as fee-based courses are available.
The UF myTraining system lists several Good Clinical Practice courses. See https://mytraining-ufshands.sumtotal.host/Core/search.
Who Can Help?
The UF Clinical and Translational Science Institute (CTSI) and Office of Clinical Research (OCR) provides assistance and resources to help UF clinical research staff comply with laws and regulations covering GCP, including:
- Clinical Research Toolkit
- Regulatory Binder Guidance (NIH)
- Templates for Regulatory Checklists and Logs
- Quality Management Tools
- Institutional Review Board (IRB) Tools
- Standard Operating Procedure (SOP) Documentation
Questions?
- Contact Sheila Austin, MS, CIP, sheila.austin@ufl.edu