For Industry

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

Purpose:

  • 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.)

  1. Introduction and Purpose of this Presentation
  2. The Sponsor: Responsibilities in Clinical Trials
  3. The Investigator: Responsibilities in Clinical Trials
  4. FDA’s Oversight of a Clinical Investigation
  5. Helpful Hints for Conducting a Quality Clinical Investigation
  6. Pertinent References

Test Your Knowledge
Answers to Quiz

To provide feedback on this training please click: Katherine Needleman

Page Last Updated: 10/27/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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