With this release to the Modernized PRS (available in the PRS Test system), 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
- Various modules
- 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
- People menu
With this release to PRS Test, 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.
- Enhancements to and remodeling of the record access list.
Completed or Coming Soon
- Links Accessible from About Menu:
- Additional Fast Forward videos
- Bug Fixes to the Protocol Section:
- 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.
- An error message will no longer be shown when an organization's preferred name or partners of an organization are entered in the Sponsor field.
- Errors shown for actual and anticipated study dates will be 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.
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 version of PRS Beta (available in the PRS Test system), PRS Beta is now the Modernized PRS, and users will see the modernized Record List page when they log into PRS Test. Study records, except for those with Results, Delayed Results, and Study Documents, will open in the Modernized PRS. Redirects are in place to send users to the Classic PRS to open records with sections that are still being modernized. In addition, improvements were made to the Record List page including styling changes. This release also includes minor enhancements and bug fixes.
Coming Soon
- The Modernized PRS (PRS Beta) will become the primary website for Protocol Registration in the PRS.
In this version of PRS Beta (available in the PRS Test system), improvements have been made to the Record list page including styling changes and new drop-down menus. This release also includes minor enhancements and bug fixes.
What's new
- Record List
- Added new drop-down menus for account management features
- Protocol Module
- Added an Edit toggle so users can turn on and off the ability to edit
- Added validation messages at the top of certain sections
- Results Module
- Continued development of Baseline Characteristics and Participants Flow
Improvements
- Record List
- Reorganized the page to accommodate additional information
- Added a link to the Administrator's Quick Reference and Problem Resolution Guide for administrative users
- Added filtering options to specific columns in response to user needs
In this version of PRS Beta (available in the PRS Test system), we've begun developing the Results modules, starting with Participant Flow. This release also includes minor enhancements and bug fixes and additional help content.
What's new
- Results
- Added an Edit toggle so users can turn on and off the ability to edit results
- Provided a draft left-side menu for results modules (still in development)
- Participant flow - first module of the results section is available for viewing and editing results data
- Other Results modules and Results Summary are still under development
Improvements
- Various styling changes, including spacing, icons, and pagination
Coming soon
- Continued development of the Results modules
In this version of PRS Beta (available in the PRS Test system), ClinicalTrials.gov Reviewers can now add, edit, and delete comments to protocol records directly in PRS Beta. This release also includes minor enhancements and bug fixes and additional help content.
What's new
- Protocol quality-assurance (QA)/quality-control (QC)
- ClinicalTrials.gov Reviewers can now review the protocol records and provide review comments in PRS Beta.
- 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.
Coming soon
- Release of these enhancements to the PRS production system
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
- Release of these enhancements to the PRS production system
In this version of PRS Beta (available in the PRS Test system), more functionality has been added to the Protocol Summary and Record Summary pages. New or updated onscreen guidance, slide-out drawers with additional information, and various bug fixes are also included in this release.
What's new
- Record Summary/Record Actions
- "People" was added as a menu option.
- PRS Record Owners and Administrators can control who has access to study records.
- Users can be emailed directly from the record access list.
- The record owner and the person who last updated the study can be identified and emailed.
- The record owner can be changed by a PRS Administrator.
- A record status bar shows the study record’s progress from creation through posting on ClinicalTrials.gov.
- The Protocol Section can be downloaded in PDF, RTF, and XML file formats.
- FDAAA 801 status is displayed onscreen and explained in a slide-out drawer.
- The ability to copy the record was added.
- "People" was added as a menu option.
- Protocol Summary
- A summary of the information for all the Protocol Section modules is now available.
- On this page, the user can click to edit individual modules.
- A collapsible list of validation messages was added at the top of the page.
- Note: The study record must still be completed, approved, and released in the classic PRS.
Bug Fixes
- Multiple bug fixes were made in several protocol registration modules.
Coming soon
- Release of version 4.0 to the PRS production site
In this version of PRS Beta (available in the PRS Test system), the outline of the record summary page has been added. In addition, error and warning messages are now displayed at the data-element level. This release also includes multiple bug fixes.
What's new
- Record summary: The framework for the record summary page, showing the current status of a record in the PRS, and controls for managing a record were added.
- Protocol summary: The framework for the protocol summary page was added, and several modules were completed.
- Note: Not all of the protocol summary modules are finished.
- Validation messages: Errors and warnings are now displayed at the data-element level.
Bug Fixes
- Multiple bug fixes were made in several protocol registration modules.
Coming soon
- Additional updates to the record actions, the record summary, and the protocol summary page
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
The Contacts and Locations module was updated in the Protocol Section in PRS Beta and is available in the PRS Test system. Several other modules have also been completed. All modules now include new or updated onscreen guidance, slide-out drawers with additional help, and content specific to the type of study (interventional, observational, or expanded access). This release also includes bug fixes for general content and formatting issues.
What's new
- Protocol Section
- Contacts and Locations module: We updated the design and navigation and added onscreen and drawer guidance.
- Arms and Interventions module: The Cross References table was added.
- Outcome Measures module: New onscreen and drawer guidance added.
We’ve added two new modules to the Protocol Section in PRS Beta (available in the PRS Test system) and completed the Sponsors and Collaborators module. Both modules have new or updated onscreen guidance, slide-out drawers with additional help, and content specific to the type of study (interventional, observational, or expanded access). This release also includes bug fixes for general content and formatting issues.
What's new
- Protocol Section
- Sponsors and Collaborators module: The auto-suggest feature for Collaborators and for the Investigator Affiliation has been added.
- Arms and Interventions module: A new screen design with improved navigation has been implemented.
- Note: This module is still in progress and is not yet fully functional.
- Outcome Measures module: A new screen design with improved navigation.
Known issues
- Data elements may not have the correct requirement symbols (*, *§, and [*]). We are currently working to correct this issue.
Coming Soon
- The Contacts and Locations module
We’ve added the Oversight module to the Protocol section in PRS Beta. In addition, we've expanded the help content in the Study Design module and developed a new design for error handling. This release also includes various bug fixes.
In this version of PRS Beta (available in the PRS Test System), more modules have been added to the Protocol Section, including the Study Design, Eligibility, and References modules. Each one 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). This release also includes various bug fixes.
What's new
- Protocol Section
- Eligibility Module: Detailed guidance has been added to clarify Gender Based eligibility.
- References Module: A simplified format for adding citations has been provided.
Improvements
- Conditions module:
- Fields in this module are now Medical Subject Headings (MeSH) responsive, meaning that when users type a word in the text box, a list of suggested MeSH terms will be displayed.
- General
- Compliance with Section 508 of the Rehabilitation Act of 1973 has been improved.
Coming Soon
- Oversight module
In this version of PRS Beta, additional modules have been added to the Protocol Section. 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.
What's new
- IPD Sharing Statement Module
- Onscreen introductory guidance has been added to encourage the inclusion of complete information.
- Conditions Module
- Conditions (or the focus of the study) can now be added using a single text box.
- Keywords can also now be added using a single text box.
- Each entered term will be displayed individually and can be viewed and removed easily.
- 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.
In this version of PRS Beta, users can create a new record and edit the Study Identification and Study Description modules of the Protocol Section. We’ve also added more accessible and understandable help content to protocol data elements.
What's new
- On-Demand Guidance
- Onscreen content has been added or revised for greater clarity
- A slide-out drawer with additional help content has been included
- The slide-out drawer can be accessed through information icons next to the data elements
- The drawer contains help and guidance in the form of descriptions, additional information, and data element definitions
- Displayed guidance is relevant to the chosen Study Type (Interventional, Observational, or Expanded Access)
- Left-hand Navigation Rail
- Users can now access modules in any order they choose once the record has been created.
Bug fixes for the Record List page have been released to the PRS Test system and will be available in the PRS in the coming weeks. These fixes have been made, in part, in response to user feedback, so please use the Feedback button to contact ClinicalTrials.gov with any comments or concerns.
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.
- A banner was added to address users with 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
- The Planning View and Public Site View have been added
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.
- The filtering for columns with names was updated to make searching easier
- 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.
- Customize and save your view
- 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.