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:
- Results of an investigation are reliable and valid
- Rights, safety and welfare of human subjects are protected
- 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.)
- Introduction and Purpose of this Presentation
- The Sponsor: Responsibilities in Clinical Trials
- The Investigator: Responsibilities in Clinical Trials
- FDA’s Oversight of a Clinical Investigation
- Helpful Hints for Conducting a Quality Clinical Investigation
- Pertinent References
Test Your Knowledge
Answers to Quiz
To provide feedback on this training please click: Katherine Needleman