Confimedis Platform v3.6.3
Overview
| Scope | Maintenance |
|---|---|
| Version | v3.6.3 |
| Release date | March 4, 2026 |
| Deployed to Confimedis Cloud | — |
| Affected modules | eConsent, Participant, Surveys, Subjects, Users |
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
- eConsent: Study participants can now download signed eConsent documents in PDF format from surveys and the mobile application immediately after completion.
- eConsent: Withdrawn consent signatures are now visually highlighted with an exclamation mark icon for better clarity.
- Participant: Important documents (e.g., eConsent or information material) are now displayed and accessible at the top of the mobile participant application.
- Surveys: Survey settings now include a section with defaults that are automatically applied to new survey links and QR codes, starting with the option to show existing data.
Bug fixes
- Subjects: Fixed users being unexpectedly logged out due to session timeout or inactivity when uploading large files that took more than 10 minutes.
- Subjects: Fixed file names not being persisted correctly when resuming a previously canceled large file upload.
- Users: Fixed the permission to view published documents not being available for the study participant role.
- Participant: Fixed mandatory fields not being validated during participant data entry, allowing them to be submitted empty.