Confimedis Plattform v3.17.0

Features

• Settings: Database Lock
  • A project can now be locked in the Settings under Database lock, for example for an interim analysis or once the data collection is complete, which suspends all permissions to edit study data (such as adding subjects, entering data, opening queries, randomizing, or importing) for every user, including the project owner and administrators, while all data remains readable.
  • Selected permissions can be kept available during the lock, such as Answer queries for the sites while the remaining findings are resolved.
  • The lock can be lifted at any time in the same place, and both locking and unlocking require a reason, which is documented in the audit trail of the project.
  • A locked project shows a notice above its content, while its ePRO surveys cannot be answered and their automated invitations are paused.
  • The lock replaces the former project status Finished. Projects in that status are now in Production with a full lock, which can be lifted like any other.
• Subjects: Subject Status and Lock
  • A subject can now carry a Subject status that reflects where it stands in the study (Screening, Screen failure, Enrolled, Discontinued, or Completed), which is chosen when the subject is created or edited, shown next to the subject in the list, and available as a column and filter in the table. The former status of a subject is now named Form status.
  • A subject that left the study (Screen failure, Discontinued, or Completed) is no longer scheduled for events, shown in the calendar, or invited to ePRO surveys, while its data remains editable, for example for a completion form or open queries. A subject under Screening becomes Enrolled once it is randomized.
  • The new setting Status of new subjects decides whether subjects start under Screening, Enrolled, or without a status, no matter whether they are created by users, register themselves via a survey, or are imported. Existing projects keep tracking no status until the setting is changed, and the status and lock are included in the CDISC ODM export and import.
  • A subject can now be locked via Lock in its actions menu with the new permission Lock subjects, which prevents any change to the subject, its data, and its forms for every user, including the project owner and administrators, until the lock is lifted with Unlock. Its forms can still be signed and its queries still be processed. The ePRO surveys of a locked subject cannot be answered and their automated invitations are paused, while the participant app explains the lock in a notice and accepts no entries either.
  • Instead of being deleted, a subject is now archived via Archive with the permission Archive and delete subjects, which locks it and hides it from everyone without the permission View archived subjects (included in the former), while Restore brings it back at any time. Deleting a subject remains possible for archived subjects only, and for any subject in a project in Draft.
  • Every change to a subject (such as its key, location, study arms, status, or lock) now asks for a confirmation with a reason, which is documented in the audit trail of the subject.
  • Archived subjects are left out of all reports and, by default, of exports, where Include archived subjects adds them for a complete backup, while the export can be narrowed down to the subjects of interest, such as only completed or only unlocked ones.

Improvements

• Forms: Deleting an event, form, section, or field now also removes everything that only existed within it (such as sections, fields, choices, translations, and range checks), while elements that are still used elsewhere, such as a section reused in another form or a form version with collected data, are kept.
• Forms: Deleting an event, form, section, or field that already holds collected data is now prevented with an explanation, consistent with the assignment of events and forms, while a project in Draft remains free to remove anything, since its test data is disposable.
• Settings: The project status is now changed in its own section via Change status with a confirmation that explains each transition, and the help text of the section now reflects that versioned forms can still be changed by creating a new version.
• Settings: Archiving a project is now done via the project status with a reason and locks it entirely, while an archived project can still be opened to view its data, is listed after the active projects, and can be reopened at any time.
• Documents: The custom PDF viewer now also works on older devices and browsers, such as iPads with iPadOS 15 to 18.3, on which PDF documents previously did not load.
• eConsent: In surveys and ePRO links with Show existing data, an eConsent can now be signed by the study participant and by the person who conducted the consent interview on the same form, so that the participant downloads a PDF that carries both signatures.
• Users: If a login via Single Sign-On (such as Keycloak) fails, the error reported by the identity provider is now shown on the login page, so that it can be passed on to the support.
• Users: The preset roles now cover the more recent permissions, such as randomizing subjects, archiving them, or importing data. A preset role that is already in use keeps its permissions, since the new set applies when a preset role is assigned for the first time.
• Users: A new preset role Administrator grants every permission of a project, including the management of users, roles, locations, and the project settings, and can be adjusted like any other preset role.

Bug fixes

• Notifications: Fixed an issue where an automated ePRO invitation was no longer sent as soon as the study team had entered data in any form of the visit, so that a survey which starts with a later form or whose form was prepared in advance never reached the participant. An invitation and its reminders now end once the participant has answered, the form is complete or locked, or the link was deactivated.
• Notifications: Fixed an issue where a condition on the event or the form in a document used as an email template was never fulfilled, so that the section it guarded was missing from the automated email.
• Subjects: Fixed an issue where a visit that was skipped by its condition, or that belongs to another study arm, was shown as the next step of a subject in the list and as an entry in the calendar.
• Subjects: The lock of a form is now also enforced by the server, so that the data of a locked form can no longer be changed through direct access to the database, which the interface already prevented.
• Subjects: Fixed an issue where a value of the wrong data type, such as text in a date field, showed the custom message of a range check instead of the message about the expected data type.
• Subjects: Fixed an issue where a user with Edit specific forms could still set a Missing reason or change the form status in a form they were only allowed to view, which failed with an error message.
• Subjects: Fixed an issue where a repeating visit with an offset of 0 days from its predecessor was only scheduled for its first day, so that the following repetitions had no date.
• Surveys: Fixed an issue where the header image of a form was not shown in surveys when the file name of the image contained spaces.