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• Instructions for FDAAA Final Rule data element submission during Phase 1.  :
  
  • Use CTRP for trial registration.
   
  • Submit the new/modified FDAAA Final Rule data elements to the CTRO to update the trial record during new trial/amendment abstractions.
   
  • Complete this Microsoft Excel template and submit to the CTRO: FDAAA_Final_Rule_fields-5-2017.xlsx.
  • If you are registering a Device trial, please contact the CTRO.
• After Phase 2, the CTRP trial registration website and services will be able to capture all required FDAAA Final Rule data elements, as long as they are submitted to CTRP during new trial/amendment registrations.
• For questions at any time, contact ncictro@mail.nih.gov.

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