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Confimedis Platform v3.19.1

Overview

Scope Maintenance
Version v3.19.1
Release date October 21, 2026
Deployed to Confimedis Cloud October 26, 2026
Affected modules Settings, Reports, Queries, Subjects, Surveys, 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.

Recommended action on your side

No action required
  1. Nothing to do. Your validated state is unchanged.
  2. File the Certificate of Release with your validation documentation.

Note from Confimedis on version 3.19.1

The changes concern reports, the query overview, and optional settings, so that no behavior that running studies rely on changes and no PQ test item is affected.

Changes

Improvements

  • Settings: For projects that want to operate the language model of the assistant themselves, such as to meet the requirements of their institution, the settings of the Assistant now offer an Own language model, which connects a self-hosted model through an OpenAI-compatible API (as provided by Ollama or vLLM). Without this setting, the assistant continues to use its default model by Mistral AI, which processes all data within the European Union under a Zero Data Retention agreement.
  • Reports: Every event now offers its Status and Date as fields of a report, with the status aggregated over the forms of the event as in the subject list, so that the progress of a study can be reported per visit. Tables show them as Status (Event) and Date (Event) in the rows of its repetitions, next to Status (Form) and Date (Form), and the Recruitment statistics show the status of every event as a line chart.
  • Reports: The bar chart and the line chart now accept several fields, such as the status of every event or of each repetition of a repeating event (1. Follow-up, 2. Follow-up), which the bar chart stacks per field and the line chart draws as a line per value, colored as in the subject list, while a click on a segment or point filters the report.
  • Reports: Charts now count every repetition of a repeating form or section, where only the first one was counted before, and the fields in the settings of a chart are grouped by event and form, with every event collapsed behind its name.
  • Reports: The settings of a chart now offer the other chart types that take its fields (such as the line chart and the pie chart for a bar chart of one field), so that a chart can be switched without setting it up again, as well as the size Wide, which spans two columns at the height of a medium chart.
  • Queries: The Query overview can now be searched, and its options add further columns to the table: the description of every query (Show description), the value of the field it concerns (Show affected values), and the values of selected fields of its subject (Show custom values).

Bug fixes

  • Reports: Fixed an issue where the rows of further repetitions of a repeating event or form showed no status and date in tables and in the CSV export, while the first repetition could show the status of a later one.
  • Subjects: Fixed an issue where a mandatory event with an optional form of unlimited repetitions stayed at partial progress in the subject view once that form had a second repetition.
  • Subjects: Fixed an issue where about one in sixteen subjects created with Automatic numbering or registered through a survey showed a shortened UUID instead of its number as Subject ID. Such a subject keeps a UUID (an internal identifier) as its ID, which lost a leading zero on saving and was then no longer recognized. The update restores the full UUID of the subjects concerned, so that they show their number again, which changes only this internal identifier and is recorded in their audit trail as a change by System.
  • Surveys: Fixed a rare issue in surveys and the participant app where, for a question highlighted as unanswered, the first answer chosen in a Button group, Range slider, or File upload was no longer shown and had to be chosen again.
  • General: Fixed an issue where, when a hint for a missing or invalid answer appeared or disappeared on leaving a question, the first click below it, such as on Continue, Save, or an answer option, had to be repeated.