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Confimedis Platform v3.18.1

Overview

Scope Maintenance
Version v3.18.1
Release date October 2, 2026
Deployed to Confimedis Cloud October 5, 2026
Affected modules Forms, Subjects, Queries

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.

Recommended action on your side

Review before use
  1. Read the note below and decide whether the change affects your study.
  2. If you start using one of the new functions, first re-execute the PQ test items named in the note in a test project (scope Incremental, all other items skipped) and sign the protocol.
  3. Record your decision on the Certificate of Release and file it together with the PQ protocol, if performed.

Note from Confimedis on version 3.18.1

Two changes are visible in running studies: In Subjects, the next instance of a repeating event or form without a repeating limit is marked as New instead of showing its number. The new subject status Withdrawn records a withdrawal of consent separately from Discontinued. Existing forms, roles, and sites are unchanged, and no PQ test item is affected.

Changes

Improvements

  • Forms: In addition to shared events, forms, sections, and fields, the yellow badge with the number of references now also appears on a field whose choices are referenced by other fields, making it clear that editing the choices also affects the other fields (which was previously only visible in the choices panel).
  • Forms: A form version under which data has already been collected can no longer be unpublished or deleted in Form versions, since changing it could hide the data collected with it, so that changes are made in a New draft instead.
  • Forms: Add section now asks for confirmation before the fields below move to the new section, and deleting a section offers to keep its fields in the previous section, so that an accidental split can be undone.
  • Forms: A reference to a field that no longer exists is now marked in red in the expression editor and shown as Missing field wherever the expression is displayed, so that a broken Condition or Calculation is noticed.
  • Subjects: The next instance of a repeating event or form without a Repeating limit, which is only offered so that it can be added if needed, now shows a dashed circle, a hint, and the badge New instead of its number, so that it no longer looks like an existing instance that is still missing (also in the table view).
  • Subjects: The new subject status Withdrawn records that a subject withdrew from the study, so that a withdrawal of consent can be told apart from a dropout under Discontinued in the subject list, filters, reports, and the CSV export, while neither is scheduled for events or invited to surveys anymore.

Bug fixes

  • Queries: Fixed an issue where automated queries were not created for a quality rule with a custom expression set to Apply everywhere, since the position of its field within the form could not be determined.
  • Forms: Fixed an issue where fields with collected data could be moved to another section via Add section or drag and drop, so that their data was no longer shown, which is now prevented with an explanation.