Data Definitions for Protocol Registration and Results System (PRS) Organization Account Application Form

March 2015

1. Sponsor Information

The sponsoring organization is the entity with primary responsibility for initiating and conducting the studies to be registered. For trials associated with a U.S. Food and Drug Administration investigational new drug application (IND) or investigational device exemption (IDE), the IND/IDE holder is the sponsor.

2. PRS Administrator Information

3. Regulatory Information