Contract research organization
Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.
Source
21 CFR § 312.3
Scoping language
The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part: