June 2018: What’s New on ClinicalTrials.gov PRS

PRS Review Time: Due to high volume of incoming records and current staffing, PRS Review is taking longer than usual. PRS Review of registration records is currently taking up to 10 days. PRS Review of records with results is currently taking up to 30 days, if the study appears to be an applicable clinical trial under 42 CFR Part 11 or an NIH-funded study. Other types of study records with results will take longer for review. We will post an update on these review times as needed.

Uploaded Study Document Indicator: A new Study Documents symbol has been added to the PRS Home page Record List to indicate which records include one or more uploaded study documents (Study Protocol, Statistical Analysis Plan, or Informed Consent Form). Administrators can also now filter records with Study Documents using the Custom Filter.

New Validation Messages:

New Error and Warning messages have been added to prevent and reduce Major Issues coming back after PRS Review.

  • In Protocol and Results Sections, a WARNING will appear when a non-specific outcome measure title (e.g., “Safety”, “Tolerability”, “Feasibility”, “Efficacy”, “Satisfaction”) is entered.
  • In the Adverse Event module (Results Section), an ERROR will occur if the Adverse Events Reporting Description does not explain why zero participants were at risk for all-cause-mortality, serious, or other adverse events.
  • In Baseline and Outcome Measures modules (Results Section), an ERROR will occur when the Analysis Population Description field does not explain why zero (participants or other units) were analyzed. Studies with a Primary Completion Date before January 18, 2017 will show a WARNING.

Disabled Principal Investigator as Responsible Party User Account: An ERROR is typically issued if the PRS user account selected for a PrincipaI Investigator as Responsible Party is disabled. This has been modified to a WARNING (or NOTE for studies with a Primary Completion Date before January 2008) if the study is finished and the record appears not to need further updates. Specifically, Overall Recruitment Status must be Completed, Terminated or Withdrawn. Results must either not be expected (i.e., non-ACT) or results for all primary and secondary outcome measures must be posted (i.e., no problem type of Late Results or Incomplete Results).

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