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Confimedis Platform v3.18.0

Overview

Scope Feature
Version v3.18.0
Release date September 28, 2026
Deployed to Confimedis Cloud September 29, 2026
Affected modules Reports, Users, General, eConsent, Subjects, Participant, Forms, Documents

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

Review before use
  1. Read the note below and decide whether the change affects your study.
  2. If you start using one of the new functions, first re-execute the PQ test items named in the note in a test project (scope Incremental, all other items skipped) and sign the protocol.
  3. Record your decision on the Certificate of Release and file it together with the PQ protocol, if performed.

Note from Confimedis on version 3.18.0

Three changes are visible in running studies: In the participant app, a visit now counts as answered only once the participant has completed one of its forms, so its notifications continue while only the study team has entered data. The study team can now withdraw a consent that the participant signed in a survey or the participant app. The recruitment card of the dashboard now opens the new default report Recruitment statistics. Existing forms, roles, and sites are unchanged, and no PQ test item is affected. If you set the signer of the consent interview signature to Study team only, execute PQ 7.2 Consent process can be completed in a test project first.

Changes

Summary: Reports gain line, scatter, and bubble charts, the subject status and the next event as fields, a CSV download of every chart, and the new default report Recruitment statistics. In eConsent, the signature of the person conducting the consent interview can be reserved for the study team, and the study team can withdraw a consent signed by the participant.

Features

  • Reports: New Charts, Fields, and Recruitment Statistics
    • The Subject status is now available as a field in reports (as a table column, in charts, and as a data filter) and as a column of the CSV export, in the same way as the location.
    • The Next event of a subject is now available as a field in reports as well, so that subjects can be counted and filtered by the point of the study they are at, while subjects without a current or upcoming event are listed as Not scheduled.
    • The new Line chart shows the number of subjects per value as a course, such as the subjects created by month, and is otherwise used like a bar chart, including the filtering by a click on a point.
    • The new Scatter chart plots two numerical fields against each other with a point per subject, such as the age against the weight, with the fields chosen under X-axis and Y-axis, where the first value of a subject is used for fields of repeating forms.
    • The new Bubble chart combines two categorical fields, such as the location and the subject status, and shows the number of subjects in every combination as the size of a bubble, which filters the report by both values when clicked.
    • Pie charts now show every segment in a different color, the rows of a bubble chart share these colors, and the tooltips of all charts have a neutral style that shows the color of the entry, while a filtered entry stays highlighted and the others recede.
    • Every chart and data filter can now be downloaded via Download as a CSV file with the number of subjects per value or combination, and the scatter chart with the values of every subject.
    • A chart without a description now carries the names of its fields or forms (up to three, with their grouping such as by month) as title, which follows the language of the interface and gives way to a description as soon as one is entered.
    • The new default report Recruitment statistics shows the subjects by their status, location, and month of their creation, with a filter by year and a table of all subjects, and the recruitment card of the dashboard now opens it instead of reloading.

Improvements

  • Users: When an account is temporarily locked after too many failed login attempts, the login page and the password reset page now say so, instead of reporting wrong credentials or an expired link.
  • General: Every list with a search, such as the subject list, can now be sorted by the name of its entries via Filter and sort.
  • eConsent: The signature field of the person who conducted the consent interview can now be set to Study team only under Signer, so that participants cannot sign or withdraw it in surveys, ePRO links, or the participant app, while both signatures can be given in either order.
  • Subjects: The subject list can now be filtered by the Next event of a subject (the event whose time window is open or otherwise the next scheduled one), which is also available as a column of the table view.

Bug fixes

  • Subjects: Fixed an issue where editing a subject in a project with an active randomization (for example to set its status) could unset the assigned study arm, so that its events and data were temporarily hidden.
  • Users: Fixed an issue where the setup of two-factor authentication could not be started again after an abandoned attempt (for example in another browser) until that attempt had expired.
  • Participant: Fixed an issue where a visit in the participant app counted as answered (moving to the previous visits and ending its notifications) as soon as the study team had entered data in one of its forms, such as a signed eConsent, instead of once the participant has completed one of their forms.
  • eConsent: Fixed an issue where the study team could not withdraw a consent that the participant had signed in a survey or the participant app, which everyone who may edit the form can now do as long as the form and the subject are not locked.
  • Forms: Fixed a rare issue where a field that had been deleted from a form could be restored in an incomplete state by the next change to the same section when the live connection to the server had dropped in the meantime, so that the form could no longer be opened and its export failed.
  • Documents: Fixed an issue where italic text in a printed document was not shown in italics, bold text lost its formatting after an italic word, and spaces next to formatted text or between two expressions were missing.