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Confimedis Platform v1.6.0

Overview

Scope Feature
Version v1.6.0
Release date June 13, 2024
Deployed to Confimedis Cloud —
Affected modules Participant

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

  • Participant: Participant app and self-registration
    • Study participants can now register themselves via a survey and then use a mobile web application to answer scheduled events.
    • The mobile application shows current, upcoming, and previous events and allows for editing previously made answers.
    • Participants can use multi-factor authentication and other account-related functionality.
    • The user module was updated to provide quick filters for showing team members or study participants.
    • The user module now shows a default role for participants to select forms that may be viewed or edited.

Improvements

  • A missing reason with an optional comment can now be specified for every field in a form at once.
  • The query details now automatically scroll to recently made changes to improve collaborative editing.