SMART-TRIAL updates www.smart-trial.com

Hotfix

Added

• Endpoint in the external API, that allows for activating Multiple Activation events. See our API documentation for more info.

Hotfix

Fixed

• Cleared an additional enrollment that prevented export, due to bug fixed in 2.22.5.

Hotfix

Fixed

• Attempts to create a subject via the external API with an already existing subject id, would in rare cases create an enrollment that should not exist.
• Cleared one instance of such an enrollment, that prevented export.

Hotfix

Fixed

• Previewing EQ-5D in studies with Arabic as a selected language would fail.

Hotfix

Added

• Support for Arabic as a language.
• Laptop/Desktop instructions for EQ-5D for Icelandic

Fixed

• Multiple Activation events could only be started if users had the "Subject" permission. Has instead been moved to the "Enter/Edit" permission, to ensure it is a one stop shop for data entry for regular events.

Hotfix

Changed

• When a user fails to login, their email will be added to log message saved of the incident.
• Removed "Sign up" from the login page.

Fixed

• The AE report list (for the new AE module) did not filter correctly based upon the users site access. Has now been corrected.

Hotfix

Fixed

• Locking and unlocking unscheduled events, did not create entries in the audit log.
• "Invalid Date" would be shown in the audit log, when viewing 'Query - Edit' or 'Query - Close'.
• Study Notifications had a number of model _ids missing.

Minor

Added

• "Single Question Fill Out": A new way for subjects to fill out questionnaires, one question at a time.

  • Can be toggled on under "Advanced Options" in the form builder.
  • Will present one question/information text at a time (one question per screen).
  • Only available during subject fill out, will show like a regular form when filled out / reviewed from within SMART-TRIAL.
  • Can go back and forth between questions. Can only continue forward if the question is in a savable state, i.e. no 'Block' Validation rule is broken.
  • Possible to add a footer text, that will be visible at the bottom of every screen.

• Two new study notifications are now available! Get notified when:

  • Data event has expired
  • Reminder has been sent to a subject.

• Study notification improvements

  • It is now possible to add "Additional Information" to Study Notification emails as well as webhooks.
  • The information that can be added depends on the notification trigger selected and whether it is sent as an email or a webhook.
  • Webhooks will have a range of ids available, that can be used to automate actions externally.
  • Emails will for example have 'data event names' and 'user emails' available where relevant.
  • Please see the help site for an overview of what is available here.

• New datetime format: "SAS".

  • Supports the SAS specified datetime format: DDMMMYYYY:HH:mm
  • Seconds (ss) are omitted, as they are not part of SMART-TRIAL timestamps.
  • Can be selected when generating your export.

Changed

• Updates to "Study Overview" export.

  • Added information about number of randomizations (if applicable)
  • Added information about number of enrollments on a randomization process (if applicable)
  • Restructured the pdf with new headers and groupings.

• Updates to "Status" tab in the "Data" menu

  • Added information about number of randomizations (if applicable)
  • Added information about number of enrollments on a randomization process (if applicable)

• Form Export Label is no longer hidden under "Advanced Options". It is now visible at the bottom of the initial 'Create Form' section.

• Randomization blocks are randomized for individual strata, as opposed to globally for the entire study.

• Audit Log: 'Hook' has been renamed to 'Study Notification' for better readability.

Fixed

• The 'Notes' field was missing in the Medication export. We found it and have put it in there, so the medication notes are now available in exports.
• When viewing form names in the process builder, they would always use the English translation if available. This resulted in wrong form names if the forms had been imported into a study with a different primary language than English.
• Left and right side labels for horizontal multiple choice questions (system admins only) would disappear if a new question was added or 'Preview Form' was clicked.
• Form Preview would add extra weight to fonts (making them look bold), which would not be present in subject fill out. They have now been aligned so you know exactly what your forms will look like.
• Trying to create medication via a module reference in an AE report, would cause an error to be thrown, but the medication would still be created, but not added. Now it can be done in one smooth motion again.
• Subject Authentication: An icon was slightly misplaced when viewing it on IE.
• It was not possible to add stratification randomization to a brand new process in amendment mode.
• Show rule possibilities would sometimes feel a bit too attached, and be unwilling to let go, even if the show rule question changed. We have ensured they are willing to move on.
• The font sizes used for the different steps in the Study Builder, were larger than intended.
• An error would be thrown in duplicated studies, if subject id was removed from subject attributes.
• Process rules were not keen on getting duplicated more than once, they now agree it is a good idea!
• The "Save Amendment" button in AE reports would be enabled, despite the report not being entirely ready. It now patiently waits for its turn.
• Exporting randomization lists for a study with a "stratify by site" randomization set up, would not give individual files for all the sites in the study. Instead it supplied the "All sites" and the first site.
• Trying to toggle 'Study Notification' on or off in the "Add on" section of the study builder, would cause the add-ons to jump around. They will now remain in place.
• Being idle with the Subject App Invitation dialog open, would make it impossible to enter ones password to re-authenticate. Instead a log out and login would have to be performed. The password will now be accepted.
• When rescheduling a data event, the clock would select the old time as default, instead of the current time - which could result in an error being thrown. It will now default to the current time.
• A translation for Study Start Time was missing in the audit log.
• The process show rule counter (found in the process overview screen, where you can edit/view your processes) would not count duplicated rules.
• The system incorrectly showed the button to "Go to Forms" for Information events in the Record History Tab. This is no longer the case.
• Printing an entire enrollment would fail for certain big studies. This has now been resolved - but it will still take a while if your study is big.
• The API resource "Fill External Events" would give an error, if the form you tried to fill contained an information text, or an unanswered optional question. It now allows for both information texts to be present, and will accommodate empty optional questions.
• Our ZIP code (part of the Address subject attribute) did not support UK zip codes. We now welcome UK citizens as well.

Hotfix

Changed

• Updated the API resource "Create Form Answers" so it can now be used on data events with 'Multiple Activation' enabled. Use it to send data to an already created data event activation, it cannot add a new activation.

Hotfix

This hotfix has to do with "behind the scenes" components, giving our developers better logging capabilities, to catch and investigate any potential future issues.