Registration Information

ICMJE requires trial registry at or before first patient enrollment as a condition for publication.

Source: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

The Responsible Party (RP) for an Applicable Clinical Trial must submit required clinical trial information through the Protocol Registration and Reporting System (PRS) no later than 21 days after enrollment of the first participant.

Source: https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa

–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!