← Zurück zum Änderungsprotokoll

Confimedis Plattform v3.19.1

Übersicht

Umfang Maintenance
Version v3.19.1
Veröffentlicht am 21. Oktober 2026
Bereitgestellt in der Confimedis Cloud 26. Oktober 2026
Betroffene Module Settings, Reports, Queries, Subjects, Surveys, General

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.

Empfohlene Handlung auf Ihrer Seite

Keine Handlung erforderlich
  1. Nichts zu tun. Ihr validierter Zustand bleibt unverändert.
  2. Legen Sie das Certificate of Release zu Ihrer Validierungsdokumentation.

Hinweis von Confimedis zu Version 3.19.1

Die Änderungen betreffen Berichte, die Aufgabenübersicht und optionale Einstellungen, sodass sich kein Verhalten ändert, auf das sich laufende Studien verlassen, und kein PQ-Testpunkt betroffen ist.

Änderungen

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.