Below is a summary of what was announced on ClinicalTrials.gov “What’s New”. The updates are planned for March 1st, 2016.
- A new Planning Report, accessible via the Reports menu on the Home page, lists all public records using current information in the PRS to support planning for record updates and results submission. The report includes:
- An indication of whether each record is a probable Applicable Clinical Trial (pACT) subject to FDAAA 801, and where applicable, expected dates for next protocol update and results submission
- An extensive set of optional columns, including but not limited to information used to determine whether a study is a pACT
- A download option, for input into spreadsheet applications such as Microsoft Excel
- An indication of whether a study is a pACT subject to FDAAA 801 has been added to the Record Status area on the Record Summary page. Note that the pACT indication is for informational purposes only and that the Responsible Party must determine whether a specific trial is an Applicable Clinical Trial subject to the requirements of FDAAA. For more information, see FDAAA Issues.
- Study Type (Interventional, Observational or Expanded Access) has been added as an optional column in the Public Site Report.
- The Custom Filter for the Home page Record List now includes an option to filter by the symbols used in the first column.
PRS Review Comments
- Indicators and links have been added to PRS web pages, to make it easier to recognize when a record has comments from the previous PRS Review, and to access those comments in the relevant module while editing the record. The comment flag ( ) appearing on a PRS web page indicates that a record, or portion of a record, has comments. The Record Summary page indicates whether modules with comments are unchanged since the PRS Review Comments were provided.
- For records with PRS Review Comments, the comments are now accessible from editing pages for those portions of the record that have comments.
- A validation ERROR will occur when a negative number is entered for: Overall Number of Baseline Participants Analyzed, Outcome Measure Number of Participants Analyzed, Outcome Measure Number of Units Analyzed, Total Number of Participants Affected by Serious Adverse Event, Total Number of Participants At Risk for Serious Adverse Event, Total Number of Participants Affected by any Other (Not Including Serious) Adverse Event, Total Number of Participants At Risk for any Other (Not Including Serious) Adverse Event.
There is a lot of activity in the clinical trial disclosure space. Check out our blog to keep up to date on all of the important activities and events!