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U.S. Department of Health and Human Services

For Industry

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Sponsor-Investigator Roles and Responsibilities in Clinical Investigations for Drug and Biological Orphan Products


  • To provide awareness to sponsors and investigators of important responsibilities to adequately conduct clinical trials
  • This knowledge is important to ensure:
    1. Results of an investigation are reliable and valid
    2. Rights, safety and welfare of human subjects are protected
    3. Investigation is conducted in compliance with regulatory requirements
Online Video Presentation (with Captioning): (Click each title below to view the section. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.)

I.     Introduction and Purpose of this Presentation 
II.    The Sponsor: Responsibilities in Clinical Trials
III.   The Investigator: Responsibilities in Clinical Trials
FDA’s Oversight of a Clinical Investigation
V.    Helpful Hints for Conducting a Quality Clinical Investigation
VI.   Pertinent References

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To provide feedback on this training please click:  Katherine Needleman