The goals of DSI are to:

• To verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications.
• To assure that the rights and welfare of human research subjects are protected.
  

DSI Accomplishes this by:

• Auditing and verifying clinical trial data submitted to the FDA in support of applications to demonstrate the safety and efficacy, or bioequivalence, of drugs for human use; 
• Directing inspections of Institutional Review Boards (IRBs) for compliance with standards and regulations designed to protect the rights and welfare of human research subjects; and 
• Ensuring that investigators, sponsors, and contract research organizations who conduct nonclinical and clinical studies on investigational new drugs comply with United States laws and regulations covering good clinical practice and good laboratory practice.

In the News

• FDA proposes changes to the informed consent elements (December 29, 2009)
• FDA, European Medicines Agency Launch Good Clinical Practices Initiative (August 3, 2009)
• Previous DSI News