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March 2023: What’s New on ClinicalTrials.gov

On March 09, 2023, an update was posted on ClinicalTrials.gov, What’s New section, as follows:

Virtual Webinar on ClinicalTrials.gov Modernization

On April 25, 2023, from 12:30 to 3:00 pm Eastern Time, a webinar will take place providing an extensive update on the current Beta website and progress updates. Attendees will have the opportunity to hear from and interact with members of the ClinicalTrials.gov modernization team and other stakeholders via chat.

To attend the webinar, registration in advance can be done through the webinar registration page. The meeting will be recorded and the recording as well as presentation slides will be available on the ClinicalTrials.gov Modernization webpage following the event.

March 2023: ClinicalTrials.gov Beta Website Update

On March 08, 2023, an update was posted on the Release notes section of the ClinicalTrials.gov Beta website, which reads as follows:

To enhance user-friendliness, the ClinicalTrials.gov Beta website has incorporated new features such as Table view, as well as improvements, and bug fixes.

The key features include:

    • The interventional and observational studies on ClinicalTrials.gov Beta now feature a new Table View that organizes study information in a way that caters to the needs of data researchers and journal editors.
    • To provide more accurate search results, a new label has been added to study records in the Table View.
    • Users can conveniently access studies by including study hyperlinks in CSV downloads.

Additionally, ClinicalTrials.gov Beta will soon introduce a feature that allows users to view record history and compare versions.

For more detailed information on these updates, please visit the Release Notes section of the Beta ClinicalTrials.gov website.

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.

January 2023: What’s New on ClinicalTrials.gov

On January 31, 2023, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

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

The key features include:

Moreover, the tabular view of the study record 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

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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December 2022: What’s New on ClinicalTrials.gov

On December 07, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

Webinar on ClinicalTrials.gov Modernization and Beta Website Progress

The recording and slides for the ClinicalTrials.gov Modernization and Beta Website Progress webinar conducted on October 27, 2022, have been added to the ClinicalTrials.gov Modernization page. The webinar featured an update on the modernization effort and a demonstration of the ClinicalTrials.gov Beta and Protocol Registration and Results System (PRS) Beta websites.

Additionally, the Report that presents an update on the ClinicalTrials.gov Beta and PRS Beta websites, future modernization activities, and more, is accessible.

November 2022: What’s New on ClinicalTrials.gov

On November 17, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

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

The key features include:

    • In addition to expanded tabular view of search results, the card view of search results is also added.
    • Users can also select and reorder the columns displayed onscreen.
    • Printer-friendly layouts for selected study records have  been included
    • Navigation and accessibility for both the desktop and mobile versions of the website have been enhanced

Moreover, the feature for ‘Study record history’ will be coming soon.

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