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Draft OpenClinica 4 Stack 20 (Scheduled Release Date – 31 January 2026)

Stack 20 introduces major updates across OpenClinica.

 

New:

Configurable Form Access Permissions

We’ve enhanced how you control form data access using permission tags. Administrators can now set access levels (Read Only, Review, Edit) for each permission tag by role — offering more flexibility than the previous role-based defaults.

Unified Permission Model

When a manual permission tag is applied to a contact form, Study Runner now uses the access level associated with the manual permission tag to determine access. This allows access to a contact form to be revoked from a CRC/Investigator or to be granted to other roles.

Seamless Migration

Your existing permissions automatically carry forward. Roles that already had specific access configured will keep them in both existing and new studies. You can update access at any time from the User Roles page.

Improved Visibility

You can now easily see which forms have special access rules.

    • Contact forms display a new icon in Study Designer.

    • The User Roles page lists tag names and access levels for quick review.

All other permissions—such as closing queries, removing or restoring data, scheduling events, or adding participants—remain managed at the role level.

Changes and Fixes:

Study Build System

  • The Advanced Calendaring menu now opens in a popup instead of a separate page, making it faster and easier to use. (OC-23668)

Study Runner

  • Forms
    • Fixed an issue where forms using cross-form logic to pull in repeating groups only populated the first instance when the form first opened. All occurrences now populate correctly. (OC-25672)
  • Queries
    • Fixed an issue where forms opened in Edit mode instead of Review mode when accessed via View Query Within Record in a frozen site. (OC-26026)
    • Queries that close automatically (e.g., when a field with an open query becomes hidden via relevant logic) now correctly show as Closed-Modified, not Closed. This ensures that any applicable constraint or required messages for the item will be shown when the form is opened again. (OC-24677)
    • Resolved an issue preventing users from managing queries or annotations in Frozen sites or studies. (OC-25861)
  • Extract Data
    • Fixed an issue where forms containing both a manual permission tag and contact data could block dataset extracts. Extracts now complete successfully. (OC-11691)
  • Data Review Tables (DRT)
    • Filtering by Open Queries within Data Review Tables now works as expected. (OC-25132)
    • Closing queries and removing/restoring forms is now correctly restricted for locked sites/studies and sites in Design status. Close Queries remains available for Frozen status. (OC-25499)
  • Miscellaneous
    • Fixed an issue where a removed form could still be opened in Edit mode via Quick Links. Now, consistent with removed events, removed forms opened through Quick Links will display in Read Only mode. (OC-25603)
    • Fixed an issue where saving Site Configuration could unintentionally update a form’s Advanced Calendaring settings (Visible and Editable). (OC-25893)
    • Removed the ability to access CRFs from the View Events page for improved consistency. The Participant Matrix and Participant Details page provide direct access to CRFs. (OC-25344)

Code

  • Fixed a duplication issue that could occur when changing a MedDRA verbatim response immediately after initial entry. (OC-25928)
  • Fixed an issue where MedDRA table configuration changes may not have been recorded in the Study Designer Activity Log. (OC-26003)
  • MedDRA table links now appear immediately in the Tasks menu after the study is published. (OC-25630)
  • Improved support for enabling MedDRA coding in ongoing studies. When the OpenClinica Code module is activated in an existing study, new verbatim items trigger an asynchronous job to autocode existing data. (OC-25186)

Insight

  • Insight now supports the new form access permission model. Contact data continues to be excluded from Insight. When Row-Level Security (RLS) is enabled, other data in contact forms or forms with restricted permission tags is hidden from users who do not have access. (OC-25045)
  • MedDRA coding data is now included in Insight marts for studies using both modules. (OC-24847)

Participate

  • Fixed an issue where participants were not always redirected correctly to the Participate dashboard after closing a form. (OC-24536)

General

  • Fixed an issue where a site’s time zone setting was not reflected across all associated studies. (OC-23928)
  • Non-Admin users can no longer edit key site details (Name, City, State, Zip, Country, Time Zone) on the Share page. (OC-24391)
  • The State/Province field now enforces a 20-character limit and displays a clear error message if exceeded. (OC-22338)
  • The User and Role Audit Log now requires Start and End Date filters (maximum range: one year) to improve performance and prevent timeouts. (OC-9499)
  • Security enhancements.

 

 

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