Study Document (PDF/A) Upload Changes: When uploading a document, if it is determined not to be in valid PDF/A format, the PRS now attempts to automatically convert the document to valid PDF/A. If the conversion is successful, a message appears indicating that the conversion has taken place and requests that the changed document be reviewed carefully before the study record is Released. The conversion to valid PDF/A is automatically noted in the Record Log. All documents should still be converted to PDF/A format prior to uploading. That is, this mechanism should not be relied upon to convert PDF to PDF/A.
The full study protocol and statistical analysis plan (SAP) must be uploaded as part of results information submission, for studies with a Primary Completion Date on or after January 18, 2017. However, an option is now provided to indicate when there was not an SAP for a study, which will remove the ERROR message for a missing SAP. If that option is chosen, a statement that the SAP does not exist will also be shown on the ClinicalTrials.gov public website.
New Results Validation Messages Intended to Reduce Major Issues: The following new 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.
- If a Baseline or Outcome Measure Title starts with “percentage of participants with [or who]…” or “number of participants with [or who]…”, the Unit of Measure should include some variant for “percent” or “participant,” respectively
- The Unit of Measure in an Outcome or Baseline Measure may not include placeholder values (e.g., “NA”) or ONLY numerals
- The Time Frame in an Outcome Measure may not ONLY be a numeral
- In an Outcome or Baseline Measure, a continuous Measure Type (e.g., mean, median, etc.) may not have a Unit of Measure of “participants” or “subjects” or “patients”
- A Baseline or Outcome Measure with a Unit of Measure of “participants” or “subjects” or “patients” should have data in whole numbers
- If the Number Analyzed in a Baseline or Outcome Measure is greater than the number Started in Participant Flow (and the Baseline or Outcome Measure Arms/Groups are similar to those in the Participant Flow), then the Baseline or Outcome Measure Analysis Population Description must include text to explain why the Number Analyzed is greater
- If the total Number at Risk for All-Cause Mortality, Serious Adverse Events, or Other (Not including Serious) Adverse Events is greater than the number Started in Participant Flow (and the respective Arms/Groups are similar to those in Participant Flow), then the Adverse Event Reporting Description must include text to explain why the Total Number at Risk is greater
- If the Enrollment specified in the Protocol Section is less than the total number Started in Participant Flow, the discrepancy should be addressed or there must be text to explain the difference in Pre-assignment Details
- In a Baseline or Outcome Measure, if a Row Title includes information about the numbers analyzed (e.g., “n= “), then the content in the Number Analyzed per Row must match
Results Edit Participant Flow: Moved the entry field for Protocol Enrollment to the Results Section, Edit Participant Flow screen to facilitate ease of entering consistent enrollment and number Started.
Update on PRS Review Time: The PRS Review time for registration study records is now back to the typical 2 – 5 business 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.