OpenClinica 4 – Release Notes 2026

OpenClinica 4 Stack 20.3 (Scheduled Release Date – 07 November 2026)

OpenClinica 4 Stack 20.3 contains targeted updates to OpenClinica. View the entire Stack 20.3 changelog here (login required). For an overview of this update, view the Stack 20.3 Release Announcement here. For more details about what this release means to you and your users, view the Impact Analysis PDF Document here (TBD).

New:

Multi-Language Forms in Form Designer

You can now edit forms that have more than one language in Form Designer. You can update existing multi-language forms, and you can create new forms and add translations to them. To start, select Manage Languages in Form Designer.

With Manage Languages, you can:

• Set the primary language of the form.
• Add, rename, and delete languages.
• Translate form content in the Translations Table.
• Edit forms that got their languages from a template upload.
• Preview the form in each language.

AI Assistant for Form Logic in Form Designer

Form Designer now helps you write form logic. Describe the rule you want in plain English, and Form Designer proposes the expression for you. Open one of the six logic panels on a question (Calculation, Default Value, Validation Criteria, Required, Relevant Logic, or Repeat Count), select AI Assistant, and type what you want the logic to do. For example: “require this field when status is active” or “calculate BMI from height and weight”. Review the proposed expression, then select Apply to add it to the panel.

With the AI Assistant, you can:

• Refer to other items on your form by name. The AI Assistant uses the full form definition, so the expression uses the correct items, choices, and groups.
• Refine an expression in more than one step. When you open the AI Assistant again, it shows your last prompt for that item and panel, so you can change the request instead of starting again.
• Keep control of your form. You must select Apply to use a proposal, and Form Designer warns you before it replaces an expression that is already in the panel.
• Get expressions that use only the functions that OpenClinica has validated.
• Find syntax errors immediately. Form Designer checks each expression when you apply it or edit it.
• See what data the AI Assistant sends. Select About AI Assistant to read what the AI Assistant sends when it makes a proposal.

Your existing expressions do not change. You can also save a form at any time, even if an expression is not complete.

French, Dutch, and Italian Translations

The OpenClinica application is now available in French, Dutch, and Italian.

Changes and Fixes:

Study Build System

Study Manager

• Changed the MedDRA section on the Modules page to add an Enter Credentials step. After you request the module, select Enter Credentials to show the MedDRA ID, MedDRA API Key, and MedDRA Version fields. After you save, the section shows the MedDRA ID and version as read-only. It does not show the API Key. (OC-28843)
• Updated the description on the Request Access version of the OpenClinica Code tile. The text now tells you that you can code clinical data in your study workflows against MedDRA for adverse events and WHODrug for concomitant medications. (OC-28843)
• Changed the module name “Insight” to “Reporting and Analytics” in the role configuration menu. (OC-28630)
• Fixed an issue where the Access column on the User Roles page showed an empty tag for roles with MedDRA Reviewer Access after the MedDRA module was deactivated. When you deactivate a coding module, the User Roles page now hides the Reviewer and Coder tags for that module. Your saved coding access does not change, and the tags show again when you reactivate the module. (OC-28838)
• Fixed an issue where a study publish could sometimes fail when many users were active in the study at the same time. Publishes now complete correctly at all levels of use. (OC-26075)

Study Designer

• Replaced the Appearance menu for items in Form Designer with a new section that shows all Appearance options for the item type. Each option has a more descriptive name and a graphic that shows its effect. Existing items show their current Appearance in the new section. (OC-27704)
• Changed the Form Style menu in Form Designer from a dropdown list to a set of icons. Each icon shows how its style looks. (OC-28582)
• Replaced the Item Width setting in Form Designer with a visual control that shows the grid and its columns. The control also shows the settings of the parent grid, so you can see how the item will look on the form. (OC-28006)
• Replaced the button that adds a new item to a form in Form Designer. The new button is easier to find and use. (OC-28570)
• Added a button to add items from the Library in Form Designer. Before this change, you could only add Library items with drag and drop. (OC-28489)
• Improved the controls to reorder and delete response list choices in Form Designer. A new drag handle lets you reorder the choices, and the delete button has a new position. (OC-28092)
• Moved the Item Group field from Advanced Options back to the main item settings in Form Designer. (OC-27680)
• Changed the term “Skip Logic” to “Relevant Logic” in Form Designer. The new term better tells you what the field does. (OC-27603)
• Added a note in Form Designer that shows when you define a calculation. The note tells you to check the Read-Only setting of the item. (OC-28464)
• Changed form previews in Form Designer to use the same method as the form card in Study Designer. Previews from the two locations now match. (OC-28086)
• Added a check when you upload a form template that has more than one language. All languages must use the standard format, for example “English (en)”. (OC-28656)
• Updated the documentation link in Form Designer to go to the new documentation site. (OC-28265)
• Changed the Show Form Description tooltip in Study Designer to use the term “eCOA” instead of the old module name “Participate”. (OC-28266, OC-28253)
• Improved the accessibility of Form Designer for screen reader users. (OC-28485)
• Fixed an issue where form previews in Form Designer and Study Designer did not work correctly in new versions of Microsoft Edge and Google Chrome. (OC-28872)
• Fixed an issue where Study Designer could become slow in very large studies. (OC-28649)
• Fixed an issue where Library search in Study Designer did not return results when the search term or the form name contained special characters, for example +, *, or /. (OC-28324, OC-28124)
• Fixed an issue where special characters in a form name could let users add more than one form with the same name to an event. (OC-27030)
• Fixed an issue where a slow network connection could sometimes create duplicate forms in the same event. (OC-28242)
• Fixed an issue in Form Designer where an extra dialog could show when you ungroup a layout group. (OC-28529)
• Fixed an issue where a form with a PII field that had no PII type selected (for example, first name or phone number) showed an error message that did not identify the problem. (OC-27891)

Study Runner

Miscellaneous

• Fixed an issue where a slow network connection could sometimes let a user sign an eConsent form before all items were saved. (OC-28825)
• Fixed an issue where an XML import that triggered calendaring rules ran the rules for only some participants. (OC-28568)
• Fixed an issue where background form processing during some imports and PDF Casebook generation could sometimes fail. These actions now give the expected results. (OC-27870)
• Fixed an issue where tabular and XML imports could accept a value that was not valid if it partly matched a valid value. (OC-18092)
• Miscellaneous security enhancements. No customer action is necessary.

General

• Changed the name “Insight” to “Reporting and Analytics” in the Tasks menu. (OC-28631)

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClinica 4 Stack 20.3 Note to File page here (TBD).

OpenClinica 4 Stack 20.2 (Release Date – 25 July 2026)

OpenClinica 4 Stack 20.2 contains targeted updates to OpenClinica. View the entire Stack 20.2 changelog here (login required). For an overview of this update, view the Stack 20.2 Release Announcement here. For more details about what this release means to you and your users, view the Impact Analysis PDF Document here.

New:

Module names updated to reflect our product rebrand

As part of our broader product rebrand, several modules on the Modules page have been updated to match: Unite → EHR-to-EDC, Insight → Reporting and Analytics, Randomize → Randomization, Participate → eCOA. Recruit, eConsent, and Code are unchanged. Functionality is unchanged across all modules. (OC-27372, OC-27934, OC-27916, OC-27917)

Search and reuse forms directly from the form card

A new Search Library button on the form card lets you find and add existing form versions from the library without leaving Study Designer. (OC-27510, OC-27512)

Build and edit eConsent forms in Form Designer

You can now build and fully edit eConsent forms in Form Designer, including adding the eConsent signature item (when the study's eConsent module is Active or Pending). (OC-27541, OC-27488, OC-27873)

New PII (encrypted) item type in Form Designer

Form Designer now has a dedicated PII (encrypted) item type for sensitive data like names or emails. Previously, encrypting this data required manually configuring a text item's Use External Value setting (previously referred to as setting the item's data type to “contactdata”); now it's built in. Encryption behavior is unchanged (as are form behavior and data export behavior), and existing manually-configured items now show as this new type. (OC-26559, OC-27687)

Bulk participant creation API (system-generated IDs)

A new API endpoint lets studies using system-generated participant IDs add participants to a site without supplying a list of IDs to create — the system generates them automatically, as if each participant had been added through the UI. (OC-25880)

Changes and Fixes:

Study Build System

Study Manager

• Fixed an issue where a user with Manage Study permission in only one environment of a study could be incorrectly redirected to the My Studies page when opening the Share page. (OC-27869)
• Fixed an issue where editing a custom user role—changing its Based On role and adjusting form access levels away from their defaults—could create duplicate permission entries on the role, leading to login errors and Insight refresh failures for users assigned that role. (OC-27559)
• An informational message now appears above the People table on the Share page when the Training Status column is hidden, explaining whether it is absent because no required training is configured for the study or because you are viewing the Test environment. (OC-27592)
• OpenClinica Team users’ Training Statuses on the Share page now display as Not Applicable, since these accounts are used only for troubleshooting and do not require training. (OC-27515)
• Fixed an issue where a training course completed ad-hoc from the Resource Center was not recorded, leaving the training status as Not Complete on the Share page. (OC-27860)
• Fixed an issue where training completed from the Resource Center could be recorded under a user’s previous role if their role had been changed earlier in the same session without logging out or switching studies. (OC-27631)
• Fixed an issue where inviting a user to a study with a role they already held could fail when duplicate training records existed for that user, preventing the invitation from completing. (OC-27719)
• Fixed an intermittent error that could appear after a user completed a training and clicked Mark as Complete, instead of returning them to the Study Runner landing page. (OC-27536)
• Fixed an issue where the hover help text for the Study Monitor role on the Edit Role and Create Role screens described incorrect permissions. The text has been corrected to accurately reflect this role's ability to view and verify source data, manage queries, and extract data. (OC-28068)

Study Designer

• Fixed an issue where a slow network connection could cause older, out-of-date results to appear when searching to add a form. (OC-27401)
• Minor Form Template updates (OC-27659):
  • Clarified the group-style instructions, noting that the field-list appearance is for forms using the pages style so you can choose the correct appearance.
  • The template now also refers to the eCOA module (formerly Participate).
  • The Form Template is now provided in XLSX format rather than XLS format.
• Administrators can now edit and delete Library entries of all types created by other users.(OC-27157)

Form Designer

• The fields used to configure form logic—Default value, conditionally Required, Calculation, and the repeat-count expression—are now shown on their own panels within the item settings menu, giving each more space and room for supporting instructions. (OC-27720, OC-27727, OC-27728, OC-27821, OC-27881)
• Changed the layout of fields in Form Designer to make it easier to edit all attributes at once, and to move more complicated fields to a separate Advanced section. (OC-27270)
• Renamed the Description and Brief Description fields for items in Form Designer and updated their help text to more clearly convey their purpose. (OC-27535)
• Renamed the item "Settings" button to "Edit" and gave it a new icon to better reflect what it does. (OC-26558)
• Item-level controls in the upper left of Form Designer now show their tooltips even when unavailable, so you can tell what each control does without having to activate it first. (OC-27530)
• Updated the Value and Image fields in multiple-choice response lists to look like editable input controls, consistent with the response text field. (OC-27600)
• Collapsing or expanding an item’s settings in Form Designer now also collapses or expands its response list section, so you no longer need extra clicks to tidy the workspace. (OC-27595)
• Renamed the media item types in Form Designer (File, Photo, Audio, Video) to include "Upload," clarifying that they let data-entry users upload files. (OC-27366)
• Fixed an issue where the "required" validation message on some Form Designer fields was too light to read easily. (OC-27511)

Study Runner

Data Review Tables (DRT)

• Fixed an issue where a user who held different roles in different studies could encounter an error when opening a Data Review Table. (OC-26302)

Study Calendaring

• Fixed an issue where calendar automation rules could erroneously schedule events that included archived forms. (OC-27024)
• Improved Study Calendar resiliency so that Run-on-Schedule rules now attempt to auto-schedule events with automatic closure dates through the end of their visit windows, rather than only through their start dates. (OC-26974)
• Made technical improvements to the reliability of calendar automation. (OC-27404)

Forms

• Fixed an issue where a form that dynamically built its response list from an item in a repeating group on another form could fail to show the response labels the first time it was opened; the labels now populate correctly every time. (OC-27231)
• Fixed an issue where select_one items inside a layout group with the field-list appearance could sometimes fail to appropriately register selections on the first tap on mobile devices. (OC-27867)

Code

• Coding now respects a study or site’s Locked, Frozen, or In Design status when determining which coding actions are allowed, consistent with other actions. Frozen allows coding; Locked and In Design do not. (OC-25608)

eCOA (formerly Participate)

• A participant’s eCOA status is now set to Invited whenever their access code or login link is sent—whether through a manual invitation, a Calendaring notification, or a Legacy Rule. Previously, automated notifications left the status as Created, which caused confusion about whether participants had been invited. (OC-26000)
• Fixed an issue where, in certain form-logic validation cases, an eCOA participant could complete a visit without filling in a required field. (OC-27534)

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClinica 4 Stack 20.2 Note to File page here.

OpenClinica 4 Stack 20.1 (Release Date – 25 April 2026)

OpenClinica 4 Stack 20.1 contains targeted updates to OpenClinica. View the entire Stack 20.1 changelog here (login required). For an overview of this update, view the Stack 20.1 Release Announcement here. For more details about what this release means to you and your users, view the Impact Analysis PDF Document here.

New:

Training is now integrated into the study access workflow

OpenClinica now supports both required role-based training for study access and optional in-product training for onboarding.

Configurable Required Training and Study Access:

• Data Managers and Administrators can now assign required training by role, making it easier to ensure users complete the appropriate training before entering a study. Required training status is visible in a dedicated column on the User Roles page and is also shown on the Share page for improved visibility during study setup and user management.
• When a user is assigned a role with required training, they are redirected to the training page before they can access Study Runner.
• After completing all required training, the user is automatically returned to Study Runner, creating a seamless training and access workflow.
• Audit log entries are recorded when a user completes an individual training module and when all required training for an assigned role has been completed, providing seamless traceability for study teams and administrators.
• As part of this new feature rollout, OpenClinica's legacy LMS is being wound down and will be deactivated soon. However, legacy training completion data, including completed courses and completion dates, will be migrated into OpenClinica 4 to preserve historical records. This will also prevent users from being required to retake courses they have already passed.

Optional training content is also integrated into the system via the Resources beacon to support easier onboarding and ongoing learning. This allows users to access helpful training materials within the platform even when training is not required for their role, making it easier to get started and build familiarity with study workflows.

Study Designer Form Search

We’ve introduced the new Study Designer Form Search feature to completely streamline form discovery and reuse. This update makes it easier to add existing forms to an event by letting you quickly find and use forms already in your study or from the Library.

Changes and Fixes:

Study Build System

• Study Manager
  • Fixed an issue where the People table on the Share page did not allow appropriate sorting. (OC-26760)
  • Fixed an issue where performing certain actions in rapid succession could incorrectly create duplicate user metadata records, leading to downstream Insight refresh failures and unexpected behavior in user management. (OC-23801)
  • The time zone labelled "GMT0" was removed from the menu of available options when setting a Site's time zone, as it was redundant with the standard GMT time zone and caused issues when used. (OC-27141)
  • Fixed an issue where study publishes intermittently failed to correctly log changes in the publish activity logs. (OC-26372)
• Study Designer
  • Changed default form designer style setting to "Simple-Single Page" to make building your first form more intuitive. (OC-26544)
  • Fixed an issue where the "&" character appeared as "&amp" in Form Designer. (OC-26595)
  • Fixed issues where Default values did not work properly in Form Designer Preview. (OC-21176, OC-14618)
  • Fixed an issue where Form Designer was displaying an error when the user tried to preview a form that contained an external list and multi-select in different groups. (OC-22435)
  • Removed the "Form Designer" title from the Library Management page and Form Designer itself. (OC-26957)
  • Updated "Library Management" button to "Library" in Study Designer. (OC-26956)

Study Runner

• Participant Details Page (PDP)
  • Fixed an issue that could cause a Common Event record to appear on more than one table page or be missing when the Common Events table was sorted. (OC-26377)
  • Removed the following text on Clear Form from Event page for accuracy: "Reason for Change is not captured for this change to the data. Be sure to document the reason for clearing this record elsewhere in your study documentation." Reason for Change is already captured for Clear Form actions. (OC-26452)
  • Fixed an issue where archiving a form version for a form in a common event prevented records for forms using that version from being migrated to new versions from the PDP. You are now able to perform version migrations on these forms as expected. (OC-25907)
• Queries
  • Improved performance of the Queries page. (OC-15673, OC-17272)
  • Fixed an issue where the discrepancy notes summary table could show incorrect totals. (OC-27202)
• Extract Data
  • Fixed an issue that was causing an unpredictable order of study metadata in extracts. (OC-27029)
• Investigator Signatures
  • Signed Participants can now be reassigned to a new site. Previously this was not possible. The signatures will remain in place and the Signed status is retained. (OC-25036)
• Source Data Verification (SDV)
  • Improved performance of Source Data Verification page. (OC-26371)
• Participate
  • The button Participants click on their dashboard to complete and submit all the form data in an event and move on has been re-labeled "Submit All". (OC-26394)
• Miscellaneous
  • Fixed an issue where changing form access from the default level while creating a new Custom User Role could cause a 500 Internal Server Error in Study Runner. (OC-26988)

General

• Fixed a rare issue that could prevent a user from logging into OpenClinica. (OC-24293)
• Previously when a user logged out of OpenClinica and then left the login page open for an extended time before logging in again, their first attempt to log back in would consistently fail, allowing them to log in on the second attempt. We have corrected this and users will now be able to log in successfully on their first attempt consistently. (OC-14870)
• The color scheme has been updated throughout the system to make the OpenClinica interface more modern and user-friendly. (OC-26767)

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClinica 4 Stack 20.1 Note to File page here.

ℹ️ Note: The Note to File is now being hosted in the OpenClinica Trust Center. In order to view it, you will need to request access.

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

Stack 20 introduces major updates across OpenClinica.

• View the full Stack 20 changelog (login required)

• Read the Stack 20 Release Announcement for a high-level overview

• See the Impact Analysis (PDF) for details about what this release means for your studies and users

• If your existing studies have manual permission tags on contact forms, please see this Customer Notification for recommended next steps

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.

Exception: Studies where manual permission tags have been applied to contact forms may need to be updated to achieve the desired level of user access. See the Customer Notification for details. (Note that all affected customers have received versions of this notice that include the studies and user roles that need to be reviewed.)

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 a popup instead of a separate page, making it faster and easier to use. (OC-23668)
• 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 shared site details (Name, City, State, Zip, Country, Time Zone) on the Share page. (OC-24391)
• The State/Province field when adding/editing sites now enforces a 20-character limit and displays a clear error message if exceeded. (OC-22338)
• The User and Role Audit Log on the Administration page now requires Start and End Date filters (maximum range: one year) to improve performance and prevent timeouts. (OC-9499)

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)
  • Fixed an issue where Edit was shown as an option in the Single Event View of the Participant Matrix even though the user did not have access to the form. (OC-23575)

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

• Security enhancements.

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