The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be:
- The Sponsor of the clinical trial (as defined in 21 CFR 50.3) who initiates the study (i.e., “Johns Hopkins University”)
- The Principal Investigator (PI)
- The Sponsor-Investigator (the individual who both initiates and conducts the study)
As a matter of policy, the “Sponsor” should be listed as the RP.