SMART-TRIAL 2019.1 (2.10)

New Features

  • Amend AE/SAE + AE changelog. (S)AEs can now be amended after sign off. This requires the 'Amend (S)AE' permission. When amending a report, the user will be prompted for a reason for the change. All changes are logged in the changelog, which can be found next to the amend button.

  • Duplicate a study. You can now duplicate an entire study structure (study, forms, process and sites).NO data or collaborator information is duplicated. This requires Setup Study permission in the 'to-be duplicated' study

  • Delete Sites. If a site is empty, i.e no subjects are enrolled, it can be deleted from the study.

  • Birth year has been added as a subject attribute that can be selected when setting up a study. If chosen, the birth year will be used in the AE/SAE module as well. If both DOB and Birth year are chosen, they are both shown in the AE/SAE module. If only DOB is chosen, only DOB is shown. If you had selected DOB in your study and now switch to birth year, DOB will still be shown as long as there is data on DOB. Once data has been removed, it will disappear.

  • Remove, is a new feature that allows the user to remove (S)AE reports, medication, medication accounting and unscheduled events from an ongoing study. Removing an item places it in Storage, here all removed items can be viewed and restored if desired. Removed items are NOT included in the export or accessible from anywhere else than the Storage.

  • Right to left languages are now supported for subject event forms.

Improvements

  • The changelog is now available while reviewing form answers, and also contains the actual changes.
  • Label text for a slider question can now be edited.
  • Collaborator + permissions overhaul
    • New permission system, please see Permission Site for more information
    • Collaborators now receive an email when invited to a study if they already have a user account
    • Collaborator roles (Investigator, Monitor, Data Entry, Sponsor) have been introduced, these should make assigning permissions quicker.
    • This release introduces the "View Identifiable Information" permission. This permission will be given as a default to all existing collaborators but can be removed. New collaborators will have it disabled as default.
  • Collaborator invitations older than 30 days will now be deleted. This change is retrospective and will affect old inactive invitations.
  • Calculated questions now have a 'number of decimals selector', allowing users to select how many decimals the calculated question should be presented with.
  • When importing forms from ones profile, it is now possible to import multiple forms at a time
  • A "Mark all as seen" button has been added to the notification list
  • Date type questions can now be used in table questions.
  • Added an announcement bulletin board to the login page, this will be used to notify users of maintenance windows, releases etc.

Changes

  • The question type Slider/VAS was renamed to Slider
  • New error page designs for errors 404 and 500
  • Medication filter has been changed to show all by default, instead of 'ongoing'

Fixed

  • Multiply activated events could not be unlocked
  • Calculated question values would be propagated to other calculated questions in the export
  • A bug in the audit log that caused "Show differences" to misbehave and show non-human readable text

Deprecated features

  • Booking module has been deprecated