Stack 19: What's New?


Study Visit Windows (Calendaring)

  • New functionality within the event card of Study Designer allows Data Managers to define visit windows for auto-scheduling and auto-closing events.

  • Automatic scheduling or closing of events can be triggered based on event status or time windows. In addition, events can be scheduled automatically when a participant is created. Actions occurring at a specific time of day will automatically be based on the site time zone of the participant.
  • This functionality will allow you to chain the scheduling of all your non-repeating visit-based events together from participant creation to participant close out, so that these events appear and close without any manual intervention by users.

Email/SMS Notifications (Calendaring)

  • New functionality within Study Designer event cards, Data Managers can define email and text notifications related to non-repeating visit-based events. These notifications can be sent to participants or other users when an event is created or completed.
  • In addition, notifications can be sent as reminders before and after the start date of an event. Multiple notifications can be configured for a single event. Notifications are configured to send based on the site's time zone.

Note: It is not recommended to use the notifications created with the legacy rules engine in addition to the notification functionality of Calendaring.


Site Time Zone

Added ability for Data Managers to define the time zone for each site on the Share page. The default time zone for each new and existing site is UTC. To see a site's specified time zone check the new Time Zone column of the Site table on the Share page. This time zone applies to all participants assigned to that site. This time zone is currently only used for the new event auto-scheduling, auto-closing, and notification features, but it will be expanded in the future.


Enhancements for Participant PDF Casebooks

Enhanced Participant PDF Casebooks to include a Participant casebook cover page, table of contents, and a form cover page for each form containing study, site, and event information. Additionally, updates were made to the headers and footers used in the casebook. The order of the forms in the Participant Casebook are now in chronological order by event start date rather than in study definition order. Finally, study-level users have an option to include forms hidden from the site when generating a PDF casebook.


Archival Casebooks

  • Added new ability for Admin Data Managers to create Archival Casebooks including all participants at a specific site or all participants in the entire study. These can optionally include removed participants and/or forms hidden at sites. Each participant casebook is identical to an individually-generated participant casebook. The total set of casebooks is compiled into a zip file.
  • All zip files contain an overall summary report and site-level summary reports. Study-level zip files are broken down with a folder per site and a folder for study-level participants. Site zip files contain data for one specific site.
  • Archival Casebook jobs appear in the bulk actions log and these jobs can be canceled before completion (if needed).


Blank Casebooks

New functionality allows Study Runner users to generate a Blank PDF Casebook for a study or site. Each file contains a casebook cover page, table of contents, a form cover page for each form containing study, site, event information, and a blank copy of each form.

The blank casebook compiles the site or study default versions of active forms, collates them by event, and creates a PDF you can download. Blank Casebook jobs are shown in the Bulk Actions log.


Annotated Casebook Enhancements

  • Form designers can provide additional detail for forms by configuring custom annotations for items including user-specified annotation labels.
  • Additionally, there are now standard annotations for choice filter, constraint type, required type, video and audio embedding, and contact data items.
  • Although they are not normally shown on the form, calculate items are now included at the end of the annotated CRF.
  • Site-level Data Managers can generate site-level annotated casebooks and compare site-level and study-level CRF configurations. One example being that two sites might have different versions of a form with different items and constraints. The study-level settings for this form could also be different from the two sites.


Insight Enhancements

  • Data Managers can now configure user role permissions to show a link directly to Insight in the Tasks menu.
  • Integrated Permissions is now a standard feature for new Insight studies (and is opt-in for existing Insight studies). It enables fully-integrated record permissions between Study Runner and Insight. This will allow Insight to automatically enforce role, site, and permission tag restrictions for user access to data. Contact OpenClinica Support for information on transitioning your existing Insight studies to this model.
  • Integrated Sign-On is now an optional feature for Insight instances. When enabled, users logged into Study Runner are granted access to Insight without logging in separately. Contact OpenClinica Support for information on transitioning your instance to this model.

Improved Participate Workflow

  • Improvements have been made to the Participate Dashboard and participants' workflow within forms to help ensure data completeness. The "Let's move on" option to complete all of a Participant's forms in an event and move on to the next event, can now only be accessed if the Participant closes the form via the "I'm Done" button on the last page of the form (which was previously labeled "Submit"), after completing all required fields.

  • In case the Participant needs to exit the form and continue data entry later, we have added a "Finish Later" button to each page of the form. This allows the Participant to leave the form when needed but will not allow them to submit the form and move on.


Display Form and Event Descriptions in Participate

Form and Event Descriptions added in Study Designer can now be configured to appear in Participate and provide context for forms or events to Participants. A checkbox is available in Study Designer, in both event and form cards, to enable display of the descriptions to Participants. Form descriptions will now also appear in the CRF metadata table on the View Study page in Study Runner.


Additional Encrypted Contact Data Fields

Forms can now be used to collect and securely store the following additional sensitive participant attributes: address, middle name, date of birth, and hospital identification number. These items are stored separately in encrypted form and are restricted from view except to Clinical Research Coordinator and Investigator users. This update allows for additional options for collecting private information at the site while taking advantage of the protections offered by the contactdata feature. These new fields can be collected in conjunction with the existing first name, last name, email address, mobile phone number, and secondary ID contactdata fields.


Participant Details Page Default Actions and Icon Updates

  • Updated the Participant Details Page Visits section to include an icon for forms that are configured to be filled out by Participants. These forms now default to opening in View mode when accessed by site and study users regardless of the form status.

  • Added the ability to verify Common Event forms for Source Data Verification (SDV) directly on the Participant Details Page.


Download Participant CDISC ODM XML Casebook

Added a download button for participant ODM XML casebooks on the Participant Details Page. This allows a user to download large ODM XML casebooks and open them in a text editor rather than in their browser. This is useful since some large ODM XML casebooks may not be able to be opened directly in a browser.


Data Manager Tasks Menu

Reorganized links in Data Manager's Tasks Menu. Under the Monitoring and Managing Data Tasks section, when accessing a specific site, the order was changed to be consistent with the study-level display.


Data Review Table Updates

Improved bulk action support by increasing action efficiency, specifically adding a "Select All" checkbox to item columns for bulk closing queries by items and adding the ability to filter to records with open queries. Expanded usability of the Data Review Table by adding participant site column. Additionally, improved user navigation via expanded table page size options.


User Attribution for System Actions

All system actions, such as autoqueries, that were previously attributed to user "root" will now be attributed to user "system" when they next occur. Audit entries for actions that occurred in the past will not be affected by this update.


Internationalization Expansion

In studies where non-English language settings are enabled, language translations have been added for participant invitations, the user login page, eConsent text, and the counter-signature page. Currently, only German translations are available. Contact your Customer Success Manager if you'd like to use a different language.


Announcement Beacon on Login Page

Added announcement pop-up icon to user login page, allowing users to access system announcement prior to logging in.


Help Links Throughout OpenClinica

Added help icons linking the user to context-specific pages of OpenClinica's documentation site throughout the OpenClinica user interface, such as Study Runner, Study Designer, and other pages. Note that some of the new documentation pages will be placeholders until new content is published.


Performance improvements

Overall performance enhancements benefiting all users with improved system responsiveness and processing improvements.


See full release notes for Stack 19 here.

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