What We Do
In relation to Good Clinical Practice, the Good Clinical Practice Program:
- Coordinates FDA policies
- Provides leadership and direction through the administration of FDA's Human
Subject Protection/Good Clinical Practice Steering Committee
- Coordinates FDA's Bioresearch Monitoring program with respect to clinical
trials, working together with FDA's Office of Regulatory Affairs (ORA)
- Contributes to international Good Clinical Practice harmonization activities
- Plans and conducts training and outreach programs
- Serves as a liaison with the HHS Office of Human Research Protection (OHRP)
and other federal agencies and external stakeholders committed to the protection
of human research participants.
