U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials

The US Food and Drug Administrations (FDA) Good Clinical Practice Program coordinates FDA policies, provides leadership and direction, contributes to international Good Clinical Practice harmonization activities, plans and conducts training and outreach programs, and 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. Listed below are some websites that provide guidance on the conduct of clinical research:

• Guidance for Institutional Review Boards and Clinical Investigators
• FDA Information for Health Professionals: Clinical Trials and Human Subject Protection
• FDA Information Sheets Guidance for Institutional Review Boards (IRB) and Clinical Investigators
• Information for Clinical Investigators-Drugs (CDER)
• Information for Clinical Investigators-Devices (CDRH)
• Information for Clinical Investigators-Biologic (CBER)

Related Information about NINDS Clinical Research
Policies and Regulatory Matters Regarding Human Subjects Research
Clinical Research General Information