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

April 18, 2017

1. Sponsor Information

The sponsoring organization is the entity with primary responsibility for initiating and conducting the studies to be registered. When a clinical study is conducted under a U.S. Food and Drug Administration (FDA) investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not conducted under an IND or IDE, the organization who initiates the study, by preparing and/or planning the study, and who has authority and control over the study, is considered the sponsor.

2. PRS Administrator Information

3. Regulatory Information