Advancing Modernized PRS Features

The ClinicalTrials.gov Protocol Registration and Results System (PRS) continues to evolve, bringing new features and enhancements that improve usability and expand functionality for clinical trial sponsors and researchers to register protocols and report results.

Here's a list of the latest features:

• The Study Documents Section and all modules of the Results Section are on the Modernized PRS.
• You can create, view, and edit results in the Modernized PRS.
• You can upload essential study documents into the Study Documents Section.
• Results Summary page:
• All modules are included on the Results Summary page.
• The Results Summary page now brings all scientific modules together in a clean, tabular format.
• Results Section module pages:
• Hover-over error icons and inline validations make it easier to spot and fix issues.
• Contacts and Location module:
• A geolocation service was added to make entering study locations faster and smarter. Plus, new buttons like Copy Locations and Set Recruitment Status help you manage multiple sites with just a few clicks.
• Baseline Characteristics module:
• Customize your baseline measures to better reflect your study's unique design, giving you more flexibility and control.
• Access and Help Content:
• Access the Modernized PRS directly from the login page.
• Fast Forward how-to demonstration videos and other help content are just a click away under the About menu.

The Results Summary page now includes all the modules of the Results Section, with tabular displays of the information in the Participant Flow, Baseline Characteristics, Outcome Measures, and Adverse Events modules. Validation messages appear near each field and at the top of the page within each module. In the tables, cells with errors are highlighted with an icon that you can hover over to see the specific error message (see Figure 1).

Figure 1: Participant Flow table with inline validations and alert icons with hover text.

In the Contacts and Locations module of the Protocol Section, the selected country is used to predict the city you are trying to enter and facilitate the entry of a study location (see Figure 2).

Figure 2: Example of geolocation-powered type ahead drop-down suggestions.

The Modernized PRS also includes a Copy Locations button to add locations from a list that includes all locations previously entered for your organization, and a new Set Recruitment Status button to change the recruitment status for each of your locations from a single screen (see Figure 3).

Figure 3: Copy Locations and Set Recruitment Status buttons.

After logging in, you will see the Modernized PRS and can check out all the new and updated features. The Classic PRS is still accessible from the Record List on the modernized website and will remain available for features not yet developed on the Modernized PRS.

Help content, including several new Fast Forward videos, can be found under the About menu on the Record List page (see Figure 4). These short, focused videos help you master the Modernized PRS quickly and confidently.

Figure 4: Help content available under the About menu.

What Features Are Planned for the Modernized PRS?

Your experience and feedback continue to inform refinements and updates to the Modernized PRS monthly.

The PRS Guided Tutorials are a set of interactive, step-by-step training resources provided by ClinicalTrials.gov to help you navigate the PRS. To provide you with detailed guidance and instructions for using the Modernized PRS, updated tutorials with instructional content, images, and examples specific to the Protocol Section of the Modernized PRS will be available soon. Updates to the Results Section of the tutorials are also in progress. These tutorials are among the help content that can be found under the About menu on the PRS Record List page, as well as on ClinicalTrials.gov under the Submit Studies tab.

Before the end of summer, you will be able to submit results modules in the Modernized PRS, making it your one-stop platform for both protocol registration and results reporting.

Future plans include XML upload functionality for the Modernized PRS, allowing you to upload a protocol document instead of entering data into individual modules, and the addition of the Delayed Results module, currently available in Classic PRS.

You are encouraged to work in the Modernized PRS, as well as the sandbox environment, PRS Test, and let us know what you think. Thank you for your feedback that helps build a better, more intuitive PRS.