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)

–Per updated Policy 103.25 “Organization Policy on Registration of Clinical TrialsJohns Hopkins University (JHU) must be identified as the RP

–Benefits of assigning JHU as the RP

  • Careful review of potential issues based on our prior experiences
  • Reduction in the number of comments you will need to respond to
  • We track the comments received to prevent future errors
  • There is no added delay, only greater probability of success!