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Confimedis Platform v2.4.0

Overview

Scope Feature
Version v2.4.0
Release date October 23, 2024
Deployed to Confimedis Cloud —
Affected modules Surveys, 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

  • Surveys: Open and logout (tablet mode) for surveys
    • Surveys can now be opened directly from within the app, which will first log out the current user.
    • After the survey is finished, a link is rendered to redirect the user back to the app, which will require a new login.
    • The redirect search parameter can also be used for custom purposes in self-embedded surveys.
  • Forms: Study arms
    • Study event groups can now be defined as arms, with customizable and translated descriptions.
    • Subjects must be explicitly assigned to a study arm in order to collect data for that arm.
  • Forms: Conditional forms
    • In addition to events, sections, and items, conditional expressions can now also be attached to forms.
    • Events and forms with unmet conditions are still rendered in the subjects list but are disabled for editing.
    • A notification is shown for each skipped form, explaining why it has been conditionally disabled.

Improvements

  • Implemented batched clinical data persistence for improved performance.