June 2021: What’s New on ClinicalTrials.gov PRS

The below update was posted on the What’s New section of ClinicalTrials.gov PRS Test, which will go live on June 27, 2021:

Late Results Problem Detection: The Late Results problem notification is now removed upon initial release of results rather than when results are posted. Similarly, the Incomplete Results problem notification is now removed upon the first release that includes all primary and secondary outcome measures.

March 2021: What’s New on ClinicalTrials.gov PRS

The below update was posted on the What’s New section of ClinicalTrials.gov PRS for March 04, 2021:

PRS Guided Tutorials
The PRS Guided Tutorials have new and updated content and features to make them more useful in response to feedback obtained through focus groups and survey responses over the past year. Enhancements include updated images and improved zoom functionality, additional study examples from materials developed for the behavioral sciences community, and revisions to the Introduction and tutorial content for added clarity and guidance. Two new sections have also been added: Quick Start Guides are designed to help users get the most from the tutorials, and the PDF Library has all of the tutorial content in a single place, readily available for download. Please note that audio narration has been removed.

January 2021: What’s New on ClinicalTrials.gov PRS

The following update has been posted on ClinicalTrials.gov PRS test, expected to go live on ClinicalTrials.gov PRS on February 01, 2021:

  • Delayed Results and Results Expected Details
    Responsible parties may now only submit certifications for delayed submission of results information prior to the date of (i.e., the day before) the standard submission deadline for results information. The standard submission deadline for results information is no later than 1 year after the ACT’s primary completion date. Related details have also been added to Results Expected date.
  • Field Length Change
    Maximum field length has been increased to 500 for the Results Participant Flow:Period(s):Milestone:Data:Comments field to make it match the allowed length in the Participant Flow:Period(s):Milestone:Comments field.
  • Review History Download
    For administrators, Review History information for all of an organization’s records can now be downloaded as comma-separated values (CSV) for input to spreadsheet applications such as Excel. This function is accessed via the PRS Home page Records menu.

October 2020: What’s New on ClinicalTrials.gov PRS

The below update has been posted on the What’s New section of ClinicalTrials.gov PRS Test, which will go live on October 01, 2020:

Record Information Download

For administrators only, information about all of an organization’s records can now be downloaded as comma-separated values (CSV) for input to spreadsheet applications such as Excel. An extensive list of fields is available with summary and status information from the PRS Home page record list, the Public Site Report, the Planning Report and the PRS Review Comments List page. Additionally, Sponsor, Collaborators, Initial Public Release Date and other fields are available. The additional fields have also been added to the Record Information application program interface (API).

The Record Information Download function is accessed via the PRS Home page Records menu. Administrators may wish to use auto-formatting features of their spreadsheet applications to make the information easier to read.

Field Length Changes

Maximum field lengths have been increased for the following Protocol Section data elements:

  • Why Study Stopped?: 250
  • Arm/Group Title: 100
  • Eligibility Criteria: 20,000

Maximum field lengths have been increased for the following Results Section data elements:

  • Participant Flow: Pre-assignment Details: 500
  • Participant Flow: Recruitment Details: 500
  • Participant Flow: Arm/Group Title: 100
  • Participant Flow: Arm/Group Description: 1500
  • Participant Flow: Period(s): Started: Comments: 500
  • Participant Flow: Period(s): Completed: Comments: 500
  • Participant Flow: Period(s): Additional Milestone(s): Comments: 500
  • Participant Flow: Period(s): Additional Milestone(s): Milestone Title: 100
  • Participant Flow: Period(s): Reason Not Completed: Other Reason: 100
  • Baseline: Arm/Group Title: 100
  • Baseline: Arm/Group Description: 1500
  • Baseline Analysis Population Description: 500
  • Baseline Measure Information: Category or Row Title: 100
  • Baseline Measure Data: NA (Not Available) Explanation: 500
  • Outcome Measure: Arm/Group Title: 100
  • Outcome Measure: Arm/Group Description: 1500
  • Outcome Measure: Analysis Population Description: 500
  • Outcome Measure: Category or Row Title: 100
  • Outcome Measure Data: NA (Not Available) Explanation: 500
  • Outcome Measure: Statistical Analyses: Method of Estimation: Confidence Interval: NA (Not Available) Explanation: 500
  • Adverse Event Information: Arm/Group Title: 100
  • Adverse Event Information: Arm/Group Description: 1500
  • Overall Limitations and Caveats: 500

July 2020: What’s New on ClinicalTrials.gov PRS

The below update has been posted on What’s New section of ClinicalTrials.gov PRS Test, which will go live on July 30, 2020:

  • pACT Results Submission Change

As a result of a recent Federal court decision, some studies determined to be probable applicable clinical trials (pACT) under the FDA Amendments Act (FDAAA) that previously showed “[Not FDAAA required]” for Results Expected dates in the PRS now show “[30 days after approval]” instead. Results Expected dates are shown on the Record Summary page and in the Planning Report. For more information on this change, see the Frequently Asked Questions on the ClinicalTrials.gov public website.

March 2020: What’s New on ClinicalTrials.gov PRS

Following update has been posted on ClinicalTrials.gov PRS Test, which will go live on April 02, 2020:

PRS Guided Tutorials Update

Registration and (PDF/A) Study Document Upload content has been added to the PRS Guided Tutorials. Links to the tutorials have replaced the links to PRS module help pages.

February 2020: What’s New on ClinicalTrials.gov PRS

ClinicalTrials.gov PRS posted following updates for February 13, 2020:

PRS Guided Tutorials: Registration Coming Soon, Tutorials Will Replace PRS Help

Registration content will be added to the PRS Guided Tutorials in early March. At that time, links to the tutorials will replace the current Help content available through PRS module help pages. We will continue to collect feedback on the PRS Guided Tutorials through a survey, intended to help us develop improved content and features.

Provide Your Comments to the ClinicalTrials.gov Request for Information

The National Library of Medicine is requesting public comment to guide efforts to enhance and better support the users of ClinicalTrials.gov, particularly within the following topic areas: Website functionality, information submission processes, and use of data standards. For consideration, your responses must be received electronically by March 14, 2020 using the web-based form linked from the Request for Information.

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

ClinicalTrials.gov PRS posted following update on December 30, 2019:

Changes to Posting Procedures for Applicable Clinical Trials

Consistent with requirements under 42 CFR 11.52, NIH must post results information for applicable clinical trials (ACTs) on the public website within 30 days of submission, regardless of whether the quality control (QC) review process is complete. For more information, see the Final Rule (42 CFR Part 11) Information page.

As of midnight EST (05:00 UTC), January 1, 2020, initial results submissions for ACTs that do not meet QC criteria will be posted publicly on ClinicalTrials.gov along with the brief standardized major issues. For details on the new procedures see the ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures.

Major Comments List

The complete list of ClinicalTrials.gov Major Comments (issues) that may be provided to the responsible party by National Library of Medicine staff during QC review is now available on the ClinicalTrials.gov public website. This list will be updated as major comments are added or retired from use.

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

Update on Review Time for Records with Results

Quality control review of all records with results is now taking less than 30 days, regardless of whether the study appears to be an applicable clinical trial under 42 CFR Part 11 or an NIH-funded study. Previously, applicable clinical trials and NIH-funded studies were prioritized for review to ensure they were reviewed in fewer than 30 days.

Workaround for Users Experiencing Crashes in Google Chrome

Some users have recently reported crashes when using the PRS in the Google Chrome browser. Currently, this issue is not being reported in other browsers. The Google Chrome Help Center has more information on this issue: Aw, Snap! Crashes Following Chrome M78 Update

We have identified a workaround for PRS users who experience this issue when using Chrome:

  1. Choose “Settings” from the Chrome main menu (look for the 3 vertical dots on the upper right side of the browser)
  2. Expand the “Advanced” options
  3. Choose “System”
  4. Disable the “Use hardware acceleration when available” option
  5. Go to chrome://flags (enter into the address bar)
  6. Disable the “Smooth Scrolling” option
  7. Relaunch Chrome

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

The PRS test environment has been updated with the upcoming “What’s New Section on PRS for August 13, 2019”. The update is as follow:

New PRS Guided Tutorials (BETA)

We have launched a new tool to help guide PRS users on how to enter their results information: PRS Guided Tutorials. A preliminary (beta) version of the tutorials is available under the Help menu on the PRS Home page.

Registration (protocol information) tutorials are currently being developed, with availability planned for late 2019.

The PRS Guided Tutorials are intended to replace much of the current PRS Help content. PRS module help pages and other content superseded by the tutorials are expected to be removed when the beta test period ends.