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Confimedis Platform v2.16.0

Overview

Scope Feature
Version v2.16.0
Release date August 13, 2025
Deployed to Confimedis Cloud —
Affected modules Forms

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

Features

  • Forms: Likert scales
    • Confimedis now provides a dedicated Likert scale field type, complete with a simple and interactive editor.
    • Visually, a Likert scale is similar to a data matrix (introduced in v2.0.0), but offers a streamlined creation process.
    • From a technical perspective, Likert scales are grouped items, enabling multiple Likert scales within one form section.
    • This technical foundation opens up possibilities for future multidimensional data collection fields, such as coordinate systems.
    • Likert scales are fully supported in PDF/A exports for robust and long-term and archival.
  • Forms: Recode and average functions
    • Added new recode function to remap coded values of multiple fields using a dictionary, enabling complex data transformations in calculations.
    • Added new average function to calculate average values across multiple fields.
    • These functions work seamlessly together to calculate scores for psychological questionnaires and scoring systems (e.g., SF-36).

Likert scale

Improvements

  • To help distinguish between different types of validation, permissive (soft) validation messages are now displayed in blue, while strict (hard) rule violations remain in red.
  • Improved performance when loading forms with many expressions that require data from other forms by fetching items in a batch.
  • Active quick filters in lists are now highlighted in blue for better recognizability.

Optional validation

Bug fixes

  • Fixed an issue where the form status could erroneously switch to Complete if a repeating section (with more than one instance) contained unanswered mandatory fields.
  • Corrected a bug where removing a codelist item (i.e., a single or multiple choice option) sometimes didn’t work when using the backspace key.
  • Solved a data export error in Chrome by requesting the directory handle before data fetch operations that could invalidate the user interaction context.
  • Resolved a permission issue where project owners with minimal rights were not able to update project settings.
  • Fixed two issues with conditions that sometimes prevented them from working in surveys or when referencing event names.