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Confimedis Platform v3.9.1

Overview

Scope Maintenance
Version v3.9.1
Release date May 3, 2026
Deployed to Confimedis Cloud May 3, 2026
Affected modules Subjects, Notifications, eConsent

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: Added the option to send direct messages to study participants from the subjects module, requiring only the new, less privileged Create local channels or Create global channels permission instead of the previously required, more sensitive View study participants or Manage study participants permission.
  • Notifications: Schedule reached notifications, sent when a scheduled event begins, can now be triggered immediately and at multiple additional offsets rather than only once at event start.
  • Notifications: Beyond the predefined offsets, custom day and minute values can now also be entered manually for all three scheduled event notification variants (Schedule reached, Announcement, and Reminder).
  • eConsent: Added the option to reset a withdrawn informed consent signature from the patient or investigator if a new signature needs to be captured.