Data Definitions for PRS Application Form

Last Modified August 2005

1. Organization/Sponsor Information

The sponsoring organization is the entity with primary responsibility for initiating and conducting the trial(s) to be registered. For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the U.S. FDA, the IND/IDE holder is the sponsor.

2. Administrator Information

3. Regulatory Information