The Division of Scientific Investigations (DSI) has two major goals:

- 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.

For more information about DSI, please see About DSI.

Need to Contact DSI?
an email, phone, fax or mail a complaint or comment to DSI. Contact DSI.

Training Course for Healthcare Providers
- CDERLearn: New Drug Development in the United States

What's New at DSI

FDA Announces the Availability of Two Guidances Related to Clinical Investigations
(June 4, 2007)

• Guidance for Industry: Computerized Systems Used in Clinical Trials (May 10, 2007)
  
  
• Draft Guidance
  Guidance for Industry Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators (May 10, 2007)
  
  Federal Register Document [HTML] [PDF]
  Comments due July 9, 2007.

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