February 2023: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on February 09, 2023.

The following updates have been made to the ClinicalTrials.gov PRS Beta test system.

    • The oversight module is added to the protocol section.
    • Expanded the help content in the study design module.
    • Developed new design for error handling.
    • Various bugs were fixed.

February 2023: What’s New on ClinicalTrials.gov

On February 08, 2023, the below update was posted on ClinicalTrials.gov, What’s New section:

Good Cause Extension (GCE) Request Process and Criteria.

The Good Cause Extension Request Process and Criteria is a document intended to explain to responsible parties the process of submitting a good cause extension request to extend the deadline for submitting clinical trial results information to ClinicalTrials.gov and the information necessary for the National Institutes of Health (NIH) to evaluate and provide a decision for the GCE requests.

New and Updated FAQs are available to clarify the Good Cause Extension Request Process and Criteria.

    • New FAQs:

The same update was posted on Clinicaltrials.gov PRS Test, which will go live on February 15, 2023:

The ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies document has been updated to reflect edits made to the following data fields in the Delayed Results section.

    • Appeal Justification
    • Requested Submission Date (Day now required)
    • Explanation

January 2023: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on January 26, 2023.

The Study Design, Eligibility, and References modules, among others, have been added to the Protocol Section. Each module has new or updated onscreen guidance, slide-out drawers with additional help, and content specific to the type of study (Interventional, Observational, or Expanded Access).

The key features include:

    • In the Eligibility modules, specific guidance has been added to address Gender-Based Eligibility.
    • In the Reference module, a simplified format for adding citations has been provided.
    • Fields in the condition module are now Medical Subject Headings (MeSH) responsive. It searches for terms found in MeSH and present matches to select from.
    • Compliance with Section 508 of the Rehabilitation Act of 1973 has been improved.

Moreover, the Oversight module will be coming soon.

December 2022: What’s New on ClinicalTrials.gov

On December 19, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

Prerecorded demonstration videos presenting features of PRS Beta and ClinicalTrials.gov Beta and highlighting changes from the classic sites are now available.

New search features, Improvements and bug fixes are added to make the  ClinicalTrials.gov Beta website more user-friendly.

The key features include:

    • Streamlined Homepage to enhance search experience
    • Provision to ‘Add All Filters’ or ‘Reset to Default’ can be accessed by the  Advanced filter dropdown
    • The record history tab has been included in the study records to view a study record’s history of changes. The elements in the study record versions that have changes are highlighted.
    • The dates have been reformatted  from month, day, year (Month DD, YYYY) to year, month, day (YYYY-MM-DD) format.

Moreover, the draft version of the new application programming interface (API) to support the beta website will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

December 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on December 15, 2022:

Users can now view and edit the Study Status module, the IPD Sharing Statement module, and the Conditions module. These modules have new or updated onscreen guidance, slide-out drawers that provide additional help, and content relevant to the selected Study Type. Validation errors will also appear on the top of each module. This release also includes various bug fixes.

The key features include:

  • Addition of an onscreen introductory guidance in the IPD sharing statement section to encourage the inclusion of complete information.
  • Conditions and Keywords can now be added using a single text box. Each entered term will be displayed individually and can be viewed and removed easily

Moreover, in the future,  the text field will be responsive to the MeSH (Medical Subject Headings) thesaurus. It will search for terms found in MeSH and present matches to select from. In addition, the field will separate conditions found in MeSH from conditions that are not.

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November 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on November 10, 2022:

Updates have been made to the PRS Test system to include two modules in the Protocol Section. These redesigned modules include on-demand help tips and guidance to make the data elements more understandable.

The key features include:

  • Users can create a new record and edit the Study Identification and Study Description modules of the Protocol Section.
  • More accessible and understandable help content for protocol data elements have been added.
  • Users can now access modules in any order they choose once the record has been created.

Detailed information on the updates can be found at here

 

July 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on July 06, 2022, which will be available on ClinicalTrials.gov PRS Beta by late July, 2022.

The following updates and improvements were made in the different section of the PRS Beta test system.

Release Notes
    • The Release Notes can now be shared without logging in to PRS Beta
    • Release Notes are now visible on a separate page. Use the back button to return to the Record List Page
Record List Page
    • A banner was added to address users with more than 250 records
      • It explains that up to 250 records can be viewed in PRS Beta
      • It provides guidance for viewing more than 250 records
Record List – Columns and Filters
    • The Planning View and Public Site View have been added
      • These views are only visible to users with Administrator access.
      • These views can be customized, filtered, sorted, and exported just like the Default View
      • Newly included columns can be filtered using a search window
    • The Group column has been added to the Default View for users with Administrator access
Improvements
Record List Page
    • A “View” link and a “Locked” link have been added to the View Record column
    • The View Record column has been removed from the Customize Columns menu and is now a permanent fixture on the left-hand side of the Record List
General
    • Accessibility (508 compliance) was improved across PRS Beta site
Help Content
    • Content was updated in “About PRS Beta”
      • A summarized update on the Planning view and Public view along with other features have been included in the “About PRS Beta” section

A notification about the ClinicalTrials.gov PRS Beta test update was also published on the ClinicalTrials.gov PRS test system.

May 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the What’s New section of ClinicalTrials.gov PRS Beta test system, which will be available on ClinicalTrials.gov PRS Beta by late May, 2022:

The following updates, improvements, and bug fixes were made in the different section of the PRS Beta test system

Record List Page
    • The release version number was added to the top of the page.
    • A loading indicator was added to track the progress of a loading page.
    • A pop-up window was added to the Contact ClinicalTrials.gov button to provide other options for finding answers to questions and getting help with using PRS Beta.
Record List – Columns and Filters
    • The filter display was adjusted so that when you filter one column, all the filter options for the remaining columns can also be seen.
    • The ability to select multiple filter options for one column was added.
    • A column was added that shows which documents, if any, have been added to a study record.
    • An alert was added that displays when the system can’t process a search request.
    • An About menu was added that includes links to the About PRS Beta page and the release notes.
Improvements
Record List Page
    • The welcome banner on PRS Beta was replaced with a pop-up banner that you can click on to close.
    • A redesigned product icon was added.
    • The labels in the page header were updated to make it easier to know which view is currently displayed (e.g., default view, saved view).
Record List – Columns and Filters
    • The filtering for columns with names was updated to make searching easier
      • Pick lists were replaced with search fields.
      • A scrollable list of possible search results was added below search windows.
      • An autocomplete feature was added that narrows the list of search options as you type.
Help Content
    • Tooltips were added for each column heading in the Customize Columns menu to explain the information found there.
    • The About PRS Beta page was updated to include descriptions of the features currently available in PRS Beta.
Style and Visual Changes

Various changes were made to improve the way the site looks. These include:

    • Saved Views menu — Changes to the pop-up window that appears when you select “Save Current View As…”
    • Record List page — Adjusted the view for different screen sizes
    • Record List column headings and filters — Added boldface to column headings and changed the font colors of filters to aid navigation and improve readability
    • Record List columns — Added highlighting to columns when sorting is applied
    • Various buttons — Adjusted the spacing
Bug Fixes
    • Column headings were fixed so that the text wraps when a column is narrowed.
Coming Soon
    • Two new views: Planning View and Public Site View

A notification about the ClinicalTrials.gov PRS Beta test update was also published on the ClinicalTrials.gov PRS test system.