April 2019: What’s New on ClinicalTrials.gov PRS

New Results Validation Messages

New validation messages now appear when “participants” (and other variants such as “subjects”, “patients”, and “responders”) are entered into the Type of Units Analyzed or Assigned fields in the Participant Flow, Baseline, and Outcome Measures results modules. These messages have been added to prevent and reduce Major Issues coming back after PRS Review. This change will be made effective from April 11, 2019.

The results validation messages will appear as an ERROR in studies with a Primary Completion Date on or after January 18, 2017 (Final Rule Effective Date) and as a WARNING for studies with a Primary Completion Date before January 18, 2017.

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