A PRS individual (user) account is established when a principal investigator wishes to register one or more trials, without coordinating with other investigators within the organization. This allows entry of trial information to begin without delay. ClinicalTrials.gov then assists in identifying the appropriate individual(s) to act as PRS administrator for the investigator's organization.

In order to avoid duplicate registration and to ensure that the appropriate organization or investigator provides the information for each trial, please consider the following questions and take the suggested steps:

1. Has the trial already been registered with ClinicalTrials.gov?
   [Search ClinicalTrials.gov for the trial(s) of interest]
   YES: There is no need to request a PRS account.
   NO: Continue
   
   
   
2. Is the trial under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application with the U.S. FDA?
   NO: Go to 4
   YES: Continue
   
   
   
3. Are you the IND/IDE holder?
   NO: Please ask the IND/IDE holder to apply for the PRS account.
   YES: Go to 6
   
   
   
4. Do you have primary responsibility for patient welfare and conduct of the protocol?
   NO: Please ask the responsible organization to apply for the PRS account.
   YES: Continue
   
   
   
5. Are you funded by the U.S. National Institutes of Health?
   YES: Please send email to register@clinicaltrials.gov including the trial title, grant number and NIH institute or center.
   NO: Continue
   
   
   
6. Is your organization already registered with the PRS?
   [Check the list of ClinicalTrials.gov data providers.]
   YES: Request contact information for your organization's PRS administrator.
   NO: Apply for a PRS account
   
   
   
   

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