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Confimedis Platform v2.0.0

Overview

Scope Milestone
Version v2.0.0
Release date August 27, 2024
Deployed to Confimedis Cloud —
Affected modules Subjects, Export, General

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

  • Subjects: Data matrix
    • Form sections can be enabled as a “data matrix” to render inputs in a tabular view.
    • Repeating sections can dynamically add and delete rows for repeating instances.
    • Subsequent sections with the same or similar questions are merged into one table.
    • When required, a matrix can be temporarily transposed to edit queries and perform SDV.
  • Subjects: Compound primary keys
    • Item data and form status models now overwrite existing data on API imports.
    • Data imports are now performed in batches to improve performance.
  • Export: Trial protocol PDF export
    • There is a new option to print all events, including all forms of a project.
    • This feature supports repeating events, forms, and sections, even if they are nested.
    • It also supports printing all clinical data for a selected subject.
    • You can now optionally add variable names and coded values to the PDF export.
  • Export: Unified CSV and PDF exports
    • In addition to the report module, CSV files can now be downloaded from the export module.
    • In addition to the forms and subject modules, PDF files can now also be downloaded from the export module. This uses the new File System Access API when PDFs for multiple subjects need to be downloaded.
  • General: Batched transactions
    • Persisting hierarchical data now uses batched database transactions to improve performance.