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Confimedis Platform v3.15.1

Overview

Scope Maintenance
Version v3.15.1
Release date August 31, 2026
Deployed to Confimedis Cloud August 31, 2026
Affected modules Subjects, Forms, Users, Notifications

Validation

Validation by Confimedis

Confimedis GmbH has validated this release in accordance with its quality management system and GAMP 5 before deployment, re-executing the test cases of the Operational Qualification (OQ) for the affected functions according to their risk classification. A release does not change the configuration of your study, such as forms, edit checks, roles, or users, which your Performance Qualification (PQ) covers. Where existing settings are migrated, the note says so. The Validation Package of every release, including the OQ report and a prefilled Validation Summary Report (VSR), is available on request and only needed for an initial validation or a revalidation. A test project is a copy of your study without patient data, created via CDISC ODM export and import.

This release predates the introduction of Release Impact Statements. Its changes are listed below.

Changes

Improvements

  • Subjects: Time and datetime fields now provide a picker with hour and minute wheels, consistent with the calendar that date fields already offer, while a time can still be typed manually (now also without a leading zero, such as 5:30).
  • Subjects: A new Phone number data type for text fields ensures that a number is entered with its country code (as +49 or 0049), which is required for an automated ePRO invitation to be delivered by SMS.
  • Subjects: The rendering of fields and sections that are shown or hidden by a Condition has been made more robust, which improves the display of long forms during data entry, especially on mobile devices.
  • Forms: The coded value of a field choice can now be changed without losing the translated texts of the other languages.
  • Forms: A Condition or Calculation that cannot be read, for example because a value was not put in quotation marks, is now reported when the expression editor is left, so that the mistake is noticed instead of silently skipping a field, section, or event, while the expression itself is still saved and can be corrected later.

Bug fixes

  • Users: Solved an issue where signing in could lead to an error after a system update, and a link that is opened while being signed out now continues to its page after signing in instead of to the dashboard.
  • Subjects: Fixed an issue where the Required status or Condition of an event assigned to multiple study arms was applied to the event of another arm instead of the one being edited.
  • Forms: Fixed an issue where a Condition or Calculation whose comparison was written without spaces around the operator was read incorrectly, so that it never applied and the affected field, section, or event was always skipped.
  • Notifications: Fixed an issue where an event whose Reference date had not been entered yet was scheduled from the date of the preceding form instead, so that its automated ePRO invitation was sent too early.
  • Notifications: Fixed an issue where an SMS that the provider rejected, for example because of a phone number without country code, was treated as sent and was therefore neither retried nor reported.