Stack 17: What's New?

Public Participant Surveys 

Allows participants to self-register for a study. Configure forms to allow Public URL within Study Designer and then create the form URL within the Site Configurations page in Study Runner. This URL can be shared in a public forum, such as a subway advertisement, social media post, etc., which can help attract potential participants. Each form submitted through this feature will create a new participant in the study. This feature allows the study to be accessed by a wide audience for easier recruitment. 

Offline Data Capture

Allows research staff to enter form data even if they do not have internet service available. Configure forms by selecting Public URL and Offline Capable in Study Designer and then create the form URL within the Site Configurations page in Study Runner. Form data entered while offline will be uploaded to OpenClinica when the user's device is back online. The form will need to be cached on the device while online prior to the user going into an offline environment. This allows data to be gathered in remote locations that do not have access to the internet. Offline data capture uses a dedicated form URL that can be configured within the Site Configurations page in Study Runner.

Integration with Cerner EHR

The Unite module can now be used with Cerner EHR. This allows a Participant Details Page to be opened from within a Cerner EHR. Data can be pulled from the EHR to OpenClinica. Additionally, Participant-specific reports are visible and visits can be managed from within the Cerner EHR environment. This expands on the integration with Epic EHR already available from the Unite module.

Integration with Apple Health

The Unite module can now be used to receive data from Participant medical records via Apple Health. Participants can be invited to connect to Apple Health from the Participant Details Page. Participants who are invited can download the OpenClinica iOS app from the Apple App Store to participate. Participants are directed to link Apple Health to the medical records maintained by their providers. After initial setup, Participants will receive notifications to transmit data from Apple Health to OpenClinica with one tap in the OpenClinica iOS app.

Data Transformation Module (DTM)

The Data Transformation Module was created to take existing files or data types that are not compatible with OpenClinica and transform them into files that can be used by OpenClinica. Files that are normally unable to be imported can be uploaded, transformed by running a custom script, and then imported. For example, a raw data file taken directly from an instrument could be transformed into a tabular file that could be imported into OpenClinica.

Completed Forms Open in View Mode by Default

Forms that are already Completed will open in View mode by default when clicking the form card on the Participant Details Page. This change will help prevent unintended data changes that could occur when opening a form in Edit mode. These forms can still be opened in Edit Mode as needed by using the form card’s Actions menu.

Embedded Reports on the Participant Details Page

The Participant Details Page can be configured to display embedded Insight reports for each Participant. Reports are first defined in Insight to display data for a single Participant. Next, the study is configured to embed that report. When the Participant Details Page is displayed after this, the report will contain data based on the specific Participant being accessed.

The Participant Details Page can also be configured to display new summary reports based on the Participant being accessed. There are two different reports available. One report can be used to display non-repeating item data from the study. The other report shows summary data from repeating events in the study.

Monitor Access to Data Review Tables

The Data Review Tables were previously only visible to Investigators, Clinical Research Coordinators, Data Managers, Data Entry Persons, and Data Specialists. Now, Monitors can also use Data Review Tables. This allows Monitors to review data on Data Review Tables and bulk close Queries appearing on the tables.

Reason for Change

Reason for Change is now required on the confirmation page when removing or restoring a participant, removing or restoring an event, or clearing a form. This text will then appear on the Queries table. This allows better accountability and documentation when removing, restoring, or clearing records. 

Show All Current Signatures on Forms

When opening a form within a signed event, all active signatures that have been added since the event last became signed will now be displayed. Previously, only the most recent signature was displayed. Now, if an event is signed multiple times without any data changes being made to it in the interim, all these signatures will be displayed on the forms in the event.

Updated Error Message in Authentication API

The Authentication API error message for expired passwords was changed to help better understand the error that occurred. The previous response in this case was status 500 "{ "message": "error.internalServerError", "description": "Internal server error", "fieldErrors": null }” and the new response is status 401 “{ "message": "error.unauthorized", "description": "The user service was not able to authenticate this request. Please confirm that your user credentials are correct or that the password has not expired.", "fieldErrors": null }”. API integrations with OpenClinica should be checked to ensure this updated error message will be handled appropriately.

Form Designer Updates

Various new features have been added to Form Designer to improve usability. These features include Bulk Add to Library, Bulk Duplicate, Duplicate for groups, support for Repeat Count parameter (previously available only when using Excel definitions), and other minor changes.

Internet Explorer 11 (IE11) Support Retired

As of June 15th, 2022, Microsoft has dropped support for Internet Explorer 11 (IE11) and recommends using an alternative browser. OpenClinica will no longer support accessing the system using IE11. We recommend any remaining IE11 users switch to a modern browser (Chrome, Edge, Firefox, or Safari) today for the best performance. 

Performance Improvements, Enhancements, and Bug Fixes

General performance improvements, usability enhancements, and bug fixes have been added throughout OpenClinica. Notably, performance improvements have been made for opening large forms (especially with many repeating groups entries), signing participants with large records, and bulk participant addition via API.

See full release notes for Stack 17 here.

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