← Back to changelog

Confimedis Platform v1.7.0

Overview

Scope Feature
Version v1.7.0
Release date July 11, 2024
Deployed to Confimedis Cloud —
Affected modules Forms, Export

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: Metadata versioning
    • Each form / eCRF now either has a version number or is in draft mode. Published forms can no longer be edited without creating a new draft first.
    • When publishing a draft, the system checks already-captured clinical data for compatibility with the new draft and shows errors for any inconsistencies.
  • Export: PDF/A export
    • Answered and empty forms, as well as entire events, can now be exported in PDF/A format.
    • The export supports repeating forms and sections, conditions, electronic signatures, descriptive texts including images, and file upload fields.
  • Export: Export and import module
    • For data exports, various options to select data are available, such as specific events, forms, locations, documents, and files.
    • When importing CDISC ODM, these options are also available, allowing you to specifically select which data should be imported.
    • Importing CDISC ODM now allows you to merge metadata into an existing project while showing already-existing events and forms.

Improvements

  • The eConsent feature now uses metadata versioning to support arbitrary patient information documents, while showing the signed version for each subject.
  • Translated conditions are now rendered directly in the editor fields.
  • Customizable preset roles with a defined set of initial rights are now available in the user management module.
  • The date picker field now supports the datetime data type.