Updates to the ClinicalTrials.gov Modernized PRS

In August 2024, the Modernized Protocol Registration and Results System (PRS) became the primary website for Protocol Registration. The PRS is used by researchers to register studies on ClinicalTrials.gov. Users logging into PRS first see the Record List on the modernized website, with links available at several locations to take them to the Classic PRS. Highlighted features of the Modernized PRS include an improved design and easier navigation. In addition, users can add information for each module of the Protocol Section in any order. Protocol data elements include concise, plain language, onscreen help content, and contextual drawer content, providing additional information at the point a user needs it, and users can submit registrations from the Modernized PRS for review by ClinicalTrials.gov staff.  

Another enhanced feature of the Modernized PRS is the ability to view a summary of the PRS Review Comments on the System Validation and Review Comments dashboard, accessed from the Record Summary tab (Figure 1).

From there, users can click on the names of modules to jump to the appropriate sections of the Protocol Summary page, where the PRS Review Comments can be viewed in full. To learn more about this feature, view the Fast Forward demonstration video on How to find and view ClinicalTrials.gov review comments in the modernized PRS.  

In addition, users can address PRS Review Comments and edit any of the modules of the Protocol Section by clicking on the Edit Mode toggle at the top of the lefthand navigation panel and then on the module of interest in the same panel. A user can also edit an individual module by clicking on the edit button at the bottom of the module card on the Protocol Summary page. These options are highlighted with red boxes in the figure below.

Recent additions include the modules of the Results Section to the Modernized PRS. Users can now create, view, and edit results information directly in the modernized system. Results modules were added in phases, starting with Participant Flow, Limitations and Caveats, and More Information, giving users the opportunity to try out these modules in the Modernized PRS and offer feedback.

Similar to the Protocol Section, features of the Modernized PRS Results Section include a user interface designed for enhanced usability and easy navigation. For example, in the Participant Flow module, a user can enter a Milestone Data Comment once and apply it to multiple cells within a row. Each module of the Results Section also includes clear, onscreen guidance, and the Results Section will provide drawer content in the future. Users will see the tables of data they’ve entered in each module on the newly available Results Summary page. Users still need to go to the Classic PRS to mark the record complete, approve, and release records with results for PRS Review.

The Study Documents Section is also now available in the Modernized PRS. Using this section, users can upload the Study Protocol, Statistical Analysis Plan, and Informed Consent documents. To request Delayed Results or to submit study records with uploaded Study Documents for PRS Review, users can go to the classic PRS.

Several features of the Protocol Section, Record Summary, and Record List have been updated in response to user feedback. System validations in the Protocol Section have been refined, and the display of some user-entered information has been updated to more closely resemble the classic experience.

PRS administrators and record owners can use a reconfigured Record Access List (Figure 4) under the People menu on the Record Summary tab to easily search for users, give them access to a record, and remove users from the access list. In addition, it is now possible to email not only individual users, but all users with access directly from the access list.

In addition, a Record Event dashboard is now available at the bottom of the Record Summary page that displays any existing Review History for the study record.

The Record List has improved navigation as well. Column headers now remain on screen as users scroll down on the page, and a horizontal scroll bar is always available to allow users to see all the columns in their selected record view. Records that have actions expected are prominently displayed in the Planning View for PRS Administrators (Figure 5).

Users can learn more about the features and functionality found on the Modernized PRS by reading About the Modernized PRS which was recently updated and now includes information about the Record page features. "About the Modernized PRS" is accessible in the About menu on the Record List page. The Modernized PRS will be the primary way to submit your results record before the end of this calendar year, and now is the opportune time for users to enter study record data in the modernized system. Feedback can be provided by clicking the yellow Feedback button (Figure 6) in the lower right corner of the Modernized PRS.