Good Clinical Practice (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. 

The UF Clinical and Translational Science Institute (CTSI) 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