← Zurück zum Änderungsprotokoll

Confimedis Plattform v3.15.1

Übersicht

Umfang Maintenance
Version v3.15.1
Veröffentlicht am 31. August 2026
Bereitgestellt in der Confimedis Cloud 31. August 2026
Betroffene Module Subjects, Forms, Users, Notifications

Validierung

Validierung durch Confimedis

Die Confimedis GmbH hat diese Version vor der Bereitstellung gemäß ihrem Qualitätsmanagementsystem und GAMP 5 validiert und dabei die Testfälle der Operationalen Qualifizierung (OQ) für die betroffenen Funktionen entsprechend ihrer Risikoeinstufung erneut durchgeführt. Eine neue Version ändert die Konfiguration Ihrer Studie nicht, etwa Formulare, Prüfregeln, Rollen oder Nutzer, die Ihre Performance Qualifizierung (PQ) abdeckt. Werden bestehende Einstellungen migriert, nennt der Hinweis dies. Das Validierungspaket jeder Version mit OQ-Bericht und vorausgefülltem Validation Summary Report (VSR) erhalten Sie auf Anfrage, Sie benötigen es nur für eine Erstvalidierung oder eine Revalidierung. Ein Testprojekt ist eine Kopie Ihrer Studie ohne Patientendaten, die Sie per CDISC-ODM-Export und -Import anlegen.

Diese Version stammt aus der Zeit vor Einführung der Release Impact Statements. Ihre Änderungen sind unten aufgeführt.

Änderungen

Improvements

  • Subjects: Time and datetime fields now provide a picker with hour and minute wheels, consistent with the calendar that date fields already offer, while a time can still be typed manually (now also without a leading zero, such as 5:30).
  • Subjects: A new Phone number data type for text fields ensures that a number is entered with its country code (as +49 or 0049), which is required for an automated ePRO invitation to be delivered by SMS.
  • Subjects: The rendering of fields and sections that are shown or hidden by a Condition has been made more robust, which improves the display of long forms during data entry, especially on mobile devices.
  • Forms: The coded value of a field choice can now be changed without losing the translated texts of the other languages.
  • Forms: A Condition or Calculation that cannot be read, for example because a value was not put in quotation marks, is now reported when the expression editor is left, so that the mistake is noticed instead of silently skipping a field, section, or event, while the expression itself is still saved and can be corrected later.

Bug fixes

  • Users: Solved an issue where signing in could lead to an error after a system update, and a link that is opened while being signed out now continues to its page after signing in instead of to the dashboard.
  • Subjects: Fixed an issue where the Required status or Condition of an event assigned to multiple study arms was applied to the event of another arm instead of the one being edited.
  • Forms: Fixed an issue where a Condition or Calculation whose comparison was written without spaces around the operator was read incorrectly, so that it never applied and the affected field, section, or event was always skipped.
  • Notifications: Fixed an issue where an event whose Reference date had not been entered yet was scheduled from the date of the preceding form instead, so that its automated ePRO invitation was sent too early.
  • Notifications: Fixed an issue where an SMS that the provider rejected, for example because of a phone number without country code, was treated as sent and was therefore neither retried nor reported.