Good Clinical Practice Program

Mission

The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA. In relation to Good Clinical Practice, the Good Clinical Practice Program:

• Coordinates FDA policies
• Contributes to leadership and direction through participation in FDA's Human Subject Protection/Bioresearch Monitoring Council
• 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 for Human Research Protection (OHRP) and other federal agencies and external stakeholders committed to the protection of human research participants