Responsible Party

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.