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Confimedis Platform v3.4.0

Overview

Scope Feature
Version v3.4.0
Release date January 19, 2026
Deployed to Confimedis Cloud —
Affected modules General, Subjects

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

  • General: For all list filters (e.g., study arms, subject status, or custom fields), the number of elements in each filter group is now displayed in parentheses after the group name.
  • General: List filters now also include a Not assigned option to find elements that are not assigned to any of the available groups (e.g., subjects without a study arm or status value).
  • Subjects: In unversioned (i.e., draft) forms, single choice fields can now be transformed to multiple choice fields, while automatically migrating potentially existing data.
  • Subjects: Study events that are shared across multiple arms (e.g., when different arms have the same visits) are now only displayed once throughout the application.
  • Subjects: In addition to the list view, assigned study arms are now also displayed in the subject table while form status icons of unassigned arms are omitted.
  • Subjects: When shallow copying a section, the conditions, calculations, and measurement units of contained items are now also copied.
  • Subjects: Users can now define relationships at three levels with the assignment matrix: Sections to Forms, Forms to Visits, and Visits to Arms. This enables flexible composition and efficient reuse of metadata elements throughout the study.
  • Subjects: In addition to repeating event instances, it’s now also possible to send a survey link or QR code for a specific repeating form instance.
  • Subjects: For non-repeating data matrices with statically defined rows, it’s now possible to transpose individual rows to normal form sections.
  • Subjects: For comprehensive data matrices and Likert scales, the table header now stays at the top while scrolling to remain visible during data entry.

List filter counts Assignment matrix

Bug fixes

  • Subjects: Solved an issue that resulted in section instances being sorted alphabetically instead of numerically.