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Confimedis Platform v3.15.0

Overview

Scope Feature
Version v3.15.0
Release date August 24, 2026
Deployed to Confimedis Cloud August 25, 2026
Affected modules Notifications, Surveys, Forms, Queries, Documents, Subjects

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

  • Notifications: Custom Documents as Email Templates
    • Custom documents can now be configured as email templates for system notifications. This allows, for example, to send custom emails to study participants when the schedule for a visit has been reached.
    • A new Notifications tab in the Send as email slideover assigns a document to a notification type, separately for team members and study participants, so that both audiences can receive a different text for the same event.
    • Title, preview text, and greetings of the document replace the default texts of the notification and its content is rendered as the body of the email.
    • A document with an action link is used for the notifications that provide one and adopts their target, such as the ePRO link of a survey, while the label of the button is taken from the document. Without an action link, the document is used for the information-only variants instead.
    • Documents are matched by language, so that one document per study language can be configured and every recipient receives the email in their own language.
    • Conditions and calculations are evaluated against the data of the respective participant, which allows the subject key to be rendered within the text or a different paragraph to be shown depending on the visit.
    • The configuration of an email now belongs to the document instead of a single version, so that it is no longer lost when a new version is drafted, and the latest published version is always the one that is sent.

Improvements

  • Surveys: A new Incomplete answers option allows participants to submit a survey or ePRO even when mandatory questions were not answered. The missing answers are highlighted and confirmed beforehand, and the form is stored with the status incomplete so that the study staff can collect them later.
  • Surveys: A new Locked answers option prevents participants from changing a page of a multi-page survey that was already submitted, for example by navigating back in the browser. Such a page is shown as read-only, while navigating back to review their own answers remains possible.
  • Notifications: Automated ePRO invitations via email or SMS for participants without an account are now sent in the primary language of the respective form when no Language field is configured, instead of always defaulting to English.
  • Notifications: Automated ePRO invitations now link to the first form of an event that is configured as a survey instead of always to the first form of the event, which allows the study staff to collect general or event-specific data in a preceding form.
  • Notifications: Automated ePRO invitations are now sent immediately after a form is answered, instead of waiting for the regular 15-minute evaluations, so that a participant who completes a registration form receives the invitation for the following event right away. The regular evaluation continues to run alongside it to cover everything that depends on time passing rather than on data being entered.
  • Notifications: Automated ePRO invitations now take study arms and event conditions into account, so that a participant only receives the invitation of the arm they were randomized into and only for events whose condition is met.
  • Notifications: Event processing on the server is now built directly on the native notification mechanism of PostgreSQL, making automated processes (such as automated queries, assignment notifications, automatic randomization, registration emails, and ePRO invitations) more robust, with all changes made during a connection drop or system update being reconciled once the system is back online.
  • Forms: A new action next to a field or section creates a condition on the answer of a preceding question with a single click, without having to open the expression editor.
  • Forms: A search field above the previously used field choices now filters them while typing, which makes it easier to find and reuse existing code lists.
  • Queries: The data validation plan and the metadata dictionary now also list the measurement unit of a field, next to its data type.
  • Queries: A condition defined on an event, form, or section is now listed as a row of its own in the data validation plan and the metadata dictionary, so that it is visible and included in the CSV export.
  • Queries: A new action in the header of a grouped column expands or collapses all of its groups at once, which makes a data validation plan or metadata dictionary that is grouped by several columns easier to navigate.

Bug fixes

  • Documents: Solved an issue on Windows that could lead to a duplicated image when moving a newly inserted image via drag-and-drop.
  • Forms: Fixed an issue in the form preview where a validation rule with a condition that references another field always reported an error.
  • Subjects: Fixed an issue where file uploads could fail if the filename contained special characters.