Release Notes

With this release to the Modernized PRS, the final module of the Results Section, Adverse Events, is now available. Users can now create, edit, and view all results modules in the Modernized PRS and can submit results in the Classic PRS. In addition, several improvements were made in response to user feedback.

What's New

• Results Section:
  • Added the Adverse Events module
  • Users can view and edit this module in the Modernized PRS
  • Added Results validations to see errors and warnings associated with this module

Improvements

• Record List:
  • Column headers now remain visible on the page when users scroll down, and users can scroll horizontally on the page at any time
• Record Summary:
  • Advisory comments provided for published registrations are now included in the System Validation and Review Dashboard
• Protocol Registration:
  • General
    • Additional validations were implemented and the logic for existing validations was updated. For example, issues related to the validation of NIH Grant numbers were resolved
  • Contacts and Locations
    • Validations for Investigators field entries on the Location page now appear in line with the fields that need attention, as well as at the top of the page
• Results Section:
  • General functional improvements were made in the Outcome Measures module

With this release to the Modernized PRS, the Outcome Measures module can now be viewed and edited in the Results Section. In addition, several improvements were made in response to user feedback.

What's New

• Results Section:
  • Added the Outcome Measures module
  • Users can view and edit this module in the Modernized PRS
  • Added Results validations to see errors and warnings associated with this module

Improvements

• Record Summary:
  • Arms and Interventions validations that were not appearing in the System Validation and Review Dashboard are now included
• Protocol Registration:
  • General
    • The Edit Mode toggle now remains in view on the left-hand panel as the user scrolls down the page
  • Study Identification
    • Spaces included in grant numbers are now processed correctly so that the grant numbers are recognized as valid
  • Sponsor and Collaborators
    • Information now transfers to the appropriate fields if the Responsible Party is changed from Sponsor-Investigator to Principal Investigator or the reverse change is made
  • Oversight
    • Updated the Error logic for the U.S. FDA-regulated Device field
  • Study Design
    • Updated the logic to trigger a Warning for the Study Phase field when other entries appear inconsistent
  • Arms, Groups, and Interventions
    • Intervention mapping from the Classic PRS is now visible in the Modern PRS
    • An Error for Interventional studies with Arm Type "No Intervention" no longer appears when Groups in Observational studies are assigned interventions
  • Outcome Measures
    • Updated the logic to trigger a Warning about Outcome Measure Titles that are not sufficiently descriptive
  • Contacts and Locations
    • System validations were updated to replicate the behavior of the Classic PRS
  • References
    • The character limit for URL Links was updated
• Results Section:
  • General functional improvements were made in the Participant Flow and Baseline Characteristics modules

With this release to the Modernized PRS, users can now create new results. In addition, a new module has been added to the Results Section, and several important improvements have been made in response to user feedback. These improvements mainly involve correcting validation errors in different sections of the study record.

What's New

• Results Section:
  • Results can be created for interventional and observational studies
  • Users can now enter Baseline Characteristics data in the modernized system
  • Customized baseline measures for Age, Sex/Gender, and Race/Ethnicity are still under development. To add these, users will need to go to the Classic PRS.

Improvements

• Record List:
  • Enhanced readability by using alternating row colors
  • Included the number of records with problems in parentheses on the Problems column header
• Record Summary:
  • Record Status bar
    • Moved the action buttons (e.g., Approve, Release) and links (e.g., Reset to In-Progress) next to the bar
    • Changed the placement of the bar shading to make it easier to see the status of the study record
  • System Validation and Review Dashboard
    • Adjusted alert icons for internal consistency between the left-hand summary panel and the right-hand listing of modules
• Protocol Registration:
  • Study Identification
    • Fixed a validation so that an error will now appear when an NCT number unrelated to the current study is entered as a Secondary ID
  • Study Status
    • Removed an error that was appearing incorrectly for a valid Verification Date
    • Removed an error that was incorrectly indicating that a month has not been selected for the Study Start Date
    • Updated rules that trigger validations related to Primary Completion Date Type (Anticipated, Actual) so warnings and errors display appropriately
  • Sponsor and Collaborators
    • Corrected the Organization name display on the Protocol Summary page for the Investigator Affiliation, Sponsor, and Collaborators fields
    • Removed repetitive warnings that were incorrectly triggered when a user account was disabled, and a valid error was shown
  • Oversight
    • Corrected the placement of an error so that it aligns with the Unapproved/Uncleared Device field
    • Removed an error that was incorrectly triggered when special characters were used in the email field for Human Subjects Review, Board Contact
    • Corrected a warning for the FDA Drug and FDA Device fields
    • Corrected validations for the Human Subjects Protection Review Board Status field in response to the Overall Recruitment Status field entry
  • Outcome Measures
    • Updated rules that trigger validations when a Primary Outcome Measure hasn't been included so errors and warnings display appropriately
  • Contacts and Locations
    • Implemented errors for locations that are missing a city name, U.S. state name, or U.S. zip code
    • Added an error that is triggered when information is missing from the Overall Study Official "Official's Role" field
    • Updated the Protocol Summary page to display the Recruitment Status for each location when the Overall Recruitment Status is set to "Recruiting"
    • Refined the rules for an error so that it now appears any time a Facility Name has not been provided for a location

With this release to the Modernized PRS, the Participant Flow, Limitations and Caveats, and More Information modules of the Results Section can be viewed and edited in the Modernized PRS. Users will need to go to the Classic PRS to work on Results Section modules that are still being developed (Baseline Characteristics, Outcome Measures and Statistical Analyses, and Adverse Events) and to submit records with results. Data entered in Modernized PRS will be saved in both the Classic and Modernized sites. In addition, several important fixes were made in response to user feedback. These updates mainly involve correcting validation errors in different sections of the study record.

What's New

• Results Section:
  • Added Participant Flow, Limitations and Caveats, and More Information modules.
    • Users can view and edit these modules in the Modernized PRS if the Results Section has already been added to the record in the Classic PRS
    • Added Results validations to see errors and warnings associated with each Results module
  • Included a Results Summary page
    • Users can view summary information for the Participant Flow, Limitations and Caveats, and More Information modules
    • Users can click on buttons to open and edit the Participant Flow, Limitations and Caveats, and More Information modules in the Modernized PRS, and to open the remaining modules in the Classic PRS

Improvements

• Protocol Section:
  • Study Status
    • Anticipated Study Start Dates now trigger errors when the entry is in the past, unless the Overall Recruitment Status is Withdrawn
  • Oversight
    • False errors are no longer displaying when answers to U.S. FDA-regulated Drug/Device or U.S. FDA IND/IDE questions are changed from "Yes" to "No"
  • Arms and Interventions
    • Validations for Device Feasibility studies were updated so that an Error or Warning displays for the Intervention data element if a device intervention has not been clearly included
  • Contacts and Locations
    • Validations for the Central Contact Backup field were updated to behave as they do in the classic system
  • Sponsors and Collaborators
    • Validations for the Sponsor, Investigator Affiliation, and Collaborator fields have been updated so that organizations names are recognized as they are in the classic system
  • Outcome Measures
    • Validations now display at the top of the page for the module

• Emails to the Responsible Party for a record are now being sent when someone other than the Responsible Party completes data entry

With this release to the Modernized PRS, several important fixes were made in response to user feedback. These include updates to make the behavior of several validations in the Protocol Section consistent with the classic system.

Improvements

• Protocol Section:
  • Various modules
    • Corrected validations for Human Subjects Protection Review Board Status fields to be more consistent with regulatory requirements
    • Removed an error message that incorrectly appeared when the correct citation format was entered in the References module
    • Removed an error that was incorrectly shown for an anticipated Study Start Date displayed using the month and year
  • Contacts and Locations
    • U.S. phone numbers for a study's central contact are now recognized and no warning message appears
    • Validations for the Investigator's last name and role are now displayed
    • A validation error no longer appears for Location cards that have been removed from the Contacts and Locations module
  • Observational Studies
    • Added a missing validation rule for the Target Duration Follow Up field for observational studies
    • Fixed an incorrect error that appeared when no intervention was entered for an observational study

• Record Summary:
  • People menu
    • Updated the Change Record Owner and Record Access lists on the People menu to include the appropriate user
    • When the Record Owner is updated using the People menu, the change is now reflected in the Status Details and Record Owner section of the Record Summary page

With this release to the Modernized PRS, several important bug fixes were made in response to user feedback and improvements were made to the record access list. In addition, two new demonstration videos were posted on Fast Forward from ClinicalTrials.gov that show how to use some of the features in the Modernized PRS. These videos can be accessed through the About menu in the Modernized PRS.

Improvements

• Record Summary:
  • Enhancements to and remodeling of the record access list.
    • Redesigned the search feature so users can search by name or username.
    • Column headers have been relabeled as "No Access" and "Access List" to clearly indicate which users have access to the record. Each user appears in a single column and can be moved to the other column as needed.
• Protocol Section:
  • Outcome measures in the Outcome Measures module are now numbered.

Completed or Coming Soon

• Links Accessible from About Menu:
  • Additional Fast Forward videos
• Bug Fixes to the Protocol Section and Record List:
  • The Unique Protocol ID will no longer trigger an error unless it is duplicated in an active record within the user's organization.
  • Deleting or renaming an arm or group in the Modernized PRS will no longer create cross-referencing errors in the Classic PRS.
  • Continuing work on making errors shown for study dates consistent with how these errors are handled in the classic system.
  • No error will be generated when the URL field for an IPD Sharing Statement has not been filled in.
  • Active user accounts will no longer produce an error in the Responsible Party field indicating that the account has been disabled.
  • Users can be more easily added to the Record Access List using several different methods.
  • On the Record List, the group column now displays the user's group name in the correct format.
  • Fields with special characters (', &, ") are displayed correctly.
  • Continuing work on board status fields so users will see fewer false errors.

With this release, the Modernized PRS (PRS Beta) is now the primary website for protocol registration. Study records containing only the Protocol Section will open by default in the Modernized PRS. Records with Results, Delayed Results, or Study Documents will open only in the Classic PRS. Redirects have been added to the modernized site to take users to the classic site to perform actions related to managing accounts, uploading records, and accessing certain help materials.

What's new

• Record List
  • The modernized Record List will open by default at log-in.
  • PRS Administrators can use the Planning View, Action Expected menu to filter for records that have corrections, updates, or results due on specific dates. This menu replaces the Action Expected button and related Custom Filter options in the Planning Report in the classic PRS.
  • The About the Modernized PRS page now includes more user guidance and is available as an Adobe PDF file.

Note:

The Modernized PRS is still under development, so users may see differences in their study records between the classic and modernized websites. If you find discrepancies, use the classic PRS to review the record and resolve any validation errors or warnings. Users should be sure to save their changes before switching between the two sites.

In this release, updates to PRS Beta have been released to the PRS. Improvements have been made to the Record List page including styling changes and new drop-down menus. All study records, except those with Results, Delayed Results, or Study Documents sections, will open in the modernized PRS (PRS Beta). This release also includes minor enhancements and bug fixes and updated help content.

What's new

• Record List
  • Added a pop-up to redirect users to the classic site if their records include Results, Delayed Results, and Study Documents sections. A single Open link will now open records that only include the Protocol Section in the modernized PRS.
  • Added menus and links to access content in the classic system, including:
    • Drop-down menus for account management features.
    • A link to the Administrator's Quick Reference for administrative users.
    • A link to the Problem Resolution Guide for all users.
  • Added a dropdown filter for the Group column (available to PRS administrators).
• Protocol Section
  • Added an Edit toggle so users can turn on and off the ability to edit.

Improvements

• Various styling changes, including spacing, icons, and pagination.
• Record List
  • Reorganized the page to accommodate additional information.

Coming Soon

• The modernized PRS (PRS Beta) will become the primary website for Protocol registration and submission.

In this release, updates to PRS Beta have been released to the PRS. PRS Reviewers can now add, edit, and delete comments to protocol records. This release also includes minor enhancements and bug fixes and additional help content.

What's new

• Protocol quality-assurance (QA)/quality-control (QC)
  • PRS Reviewers can now review the protocol records and provide review comments.
• Study Identification
  • A new Secondary ID Type, "EU Trial (CTIS) Number" was added for EU Clinical Trials Information System (CTIS) trial identifiers.

Improvements

• Record List
  • The 1,000-record limit was removed after improvements to the Record List’s loading speed.
• Added a dropdown list of states for clinical studies with facilities found in the United States.
• Improved the display of review comments in the Protocol Outcome Measures module.

In this release, updates to PRS Beta have been released to the PRS. Data submitters can now view PRS Reviewer quality-assurance (QA)/quality-control (QC) comments from the Record Summary page. This release also includes minor enhancements and bug fixes.

What's new

• Status Dashboard- Review tab
  • The numbers of major issues and advisory comments from PRS Reviewers are shown on the dashboard.
  • PRS Reviewer QA/QC comments can be viewed directly by clicking on links on the dashboard to the Protocol Summary.

In this version of PRS Beta (available in the PRS Test system), users can now submit a protocol record directly from PRS Beta for PRS Review, instead of going to the classic PRS site. Records with results and Study Documents will continue to be managed in the classic PRS. This release also includes minor enhancements and bug fixes, and additional help content has been added to the Record Summary page.

What's new

• Record Summary
  • The ability to change the status of a protocol record directly in PRS Beta was added. Records can be approved and released in PRS Beta, instead of going to the classic site.

Improvements

• Record Summary
  • Headings for each section were updated to improve clarity.
  • Added pop-out help content explaining record dates and other information found on this page.
• Record List
  • A Create New Record button was added under the Record List heading (previously available under the Records menu).

Bug fixes

• Multiple enhancements and bug fixes were made across the protocol registration modules.

Coming soon

• Addition of Quality Assurance QA/Quality Control (QC) review comments

In this release, updates to PRS Beta, including additions to the Record Summary and Protocol Summary, have been released to the PRS. The Record Summary and Protocol Summary have a new design and improved navigation. The Record Summary has updated onscreen and slide-out drawer help content. Data entered in PRS Beta will continue to be saved on both the classic and beta sites, and users will still need to use the classic PRS to submit study protocols for review.

What’s new

• General
  • A disclaimer addressing differences in the features found on PRS Beta and those on the classic PRS, and how to manage related issues, was added.

• Record Summary
  • A new section displays important record-progress dates, the record status, the record owner, and the study’s FDAAA 801 status.
  • A new record status bar allows users to follow the progress of a study record through the steps required for registration on ClinicalTrials.gov.
  • An action button has been added that takes the user to the classic PRS to submit the record.

• Actions Menu
  • The study record can now be downloaded in PDF, RTF, or XML format.
    • Explanatory information has been provided to help users decide which download option best suits their needs.
  • Users can enable or disable the ability to upload the study record and will see messages that help inform this decision.
  • The study record can be copied or deleted, and onscreen guidance is provided.

• People Menu
  • A menu focused on the people involved with the study record was added.
    • Users can identify and email the people who contributed to the study record.
    • Record owners and administrators can also control who has access to the study record.

• Protocol Summary
  • This section now displays the current data and validations for each Protocol Section module. Each module can be edited directly from the Protocol Summary by clicking on the edit button on the module.
  • Validation messages connect directly to each Protocol Section module.
    • Alerts can be expanded or collapsed, and each alert is clearly listed in the Protocol Section module.

Bug fixes

• Multiple bug fixes were made in several Protocol Section modules.

In this release, updates to PRS Beta, including all the Protocol Section modules, have been released to the PRS. Each of these modules includes a new design, improved navigation, and updated onscreen and slide-out drawer help content. Data entered in PRS Beta will be saved on both the classic and Beta sites. Users will need to use the classic PRS to submit their study protocol for review.

What's new

• Protocol tab:
  • A new design with an updated color scheme, larger fonts, and clearly identifiable sections and labels was implemented.
  • Tabs were placed at the top of the page to help users navigate to other sections of the study record.
  • A left-side menu was added to the Protocol Section for easy navigation between modules.

• General updates:
  • The Unique Protocol ID, Brief Title, and NCT number (if available) have been moved to the top of the left-side menu to make them easy to find.
  • The Create New Record option is now available under the Records menu at the top of the page.

• Help content:
  • Onscreen guidance was updated or added to each module of the Protocol Section.
  • Information icons were added next to the data elements. These icons link to slide-out drawers that provide direct access to additional help content and the data element definition.

Coming soon

• Record summary and protocol summary

What's new

• 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
  • 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"

In this second release, we improved the way the Record List looks and works. We also brought over some features from the classic PRS and addressed bugs that affected the Record List.

What's new

• 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

The initial release of PRS Beta included a new, modern look and updates to the Record List page.

What's new

• Record List - Features
  • Customize and save your view
    • Select the columns you want to see.
    • Select the order you want to see the columns in.
    • Filter each column using either a drop-down menu or search window.
    • Save up to eight custom views.
  • Adjust the width of each column.
  • Email users by clicking on hyperlinked names in the Record List.
  • Export only the displayed columns or all the columns in the Record List to either an .xlsx or .csv file.
• Record List Page - Additional Features
  • Access My Profile and My Administrators information through an icon that displays your full name and organization.
  • Click on buttons to:
    • Contact ClinicalTrials.gov with questions.
    • Give feedback about PRS Beta.
    • Learn about PRS Beta.