SMART-TRIAL updates www.smart-trial.com

Fixed

• Responding to a query would not update the answer for calculated questions in a form, when the referenced question answer has changed.

Added

• Extended functionality for Calculated Question

  • A number of new expressions have been added to allow for more complicated calculations. Please visit the help site for a full write up of the available functionality.

• Two new export attributes can be selected.

  • Form Answer Create Date - is the date the form was saved the FIRST time i.e. answers were created. If the form is used in subject events, this date doubles as "Form Completed" date.
  • Activation Count - A running number, indicating how many times a multiple activation event has been activated for a specific enrollment. It start with 1 and increases with number of activations. Only selectable using "Scheduled Events" if there is at least one multiple activation event in the process.
  • If either are selected, they will also appear in the data code file.

Changed

• Increased the allowed max length in a calculated questions formula from 1024 to 10240.
• Updated the help text underneath Calculated question to reflect the new functionality and link to the new help page.

Fixed

• Re-ordering randomization records that were affected by the bug solved in 2.18.5, to fill up blocks with 'holes' due to the bug.
• Removal of Randomization assignments to allow for re-randomization for a single study.
• Answer Not Available icon will now correctly show in the AE reports list, if an item has been marked as AnA.

Fixed

• The randomization module is forced to follow block order when assigning randomization IDs

Fixed

• Multiple activation subject events would not send out emails and smses after the first activation

Added

• Terms of Use link and required checkbox to user sign-up page

Changed

• Url for privacy policy
• Form resources to use different caching strategy

Fixed

• External API - Create form answers
  • request would fail if the data event registration was not started

Fixed

• External API - Create form answers and Update form answers endpoints
  • urls were updated to better reflect their expected behaviour
  • improved documentation of the resource and the limitations it has
• External enrollment of subjects would result in the first data event being inaccessible in some scenarios
• Ordering of data events when viewing the subject history has been corrected to follow the order seen in the site overview.
• Discontinue events missing their icons from the subject history

Fixed

• Signup through external API would fail for two studies

Added

• Emergency Unblinding - a new feature that allows specified study personnel to break the blind of an enrollment incase of emergencies. Available for studies using the randomization module.

  • Requires a reason and input of password.
  • The action is audit logged.
  • Requires a site level permission.
  • Added new Study Notification to alert specific emails or external systems in case of an emergency unblinding taking place.

• Change enrollment status functionality (System admins only).

• Change data event status functionality (System admins only).

• New API resources: 'Create form answers' and 'Update form answers'

  • Data can now be delivered directly to forms in data events via the API. Please visit our API documentation for more information.
  • The 'fill out' user is set to "API User" using these resources.

• Study Notifications using the 'Webhook' recipient can now select additional attributes to include in the 'webhook'.

  • The available attributes are: 'subject id', 'enrollment id', 'user email', 'site id', 'randomization id', and 'study id'.
  • The selection available depends on the chosen trigger.

Changed

• Naming of resource in Study notifications
  • Deliver form answers -> Fill external event
  • The URL is unchanged
• Limited horizontal multiple choice questions to be available on screen sizes of minimum 700px.
• Moved public registration link to the "SiteS overview"

Fixed

• Public sign up did not behave correctly, in case the automatic email send out was not available.
• Form preview would break if questions were re-ordered in a newly created form.
• Form preview would break if the template was changed in an AE form.
• Printed form answers would on certain studies show incorrect date for the form version
• Validation rules on table-based questions used to automatically create a query would cause fill outs from subjects to be rejected

Fixed

Form version would in some studies show as 1.0 in form list when it was in fact 0.x

This spring we will be pushing out a number of smaller releases.

Added

• EQ-5D-5L support.
  • Requires a license with Euroqol and is enabled by system admins on a specific study.
  • Support for tablet, PDA, and Desktop/laptop
  • Support for the following languages: English (UK), English (USA), German (Germany), German (Austria), and French (Canada).
  • Contact us for more info.
• Added English (USA) and German (Austria) as selectable languages.
• Horizontal multiple choice.
  • Must be enabled by system admins for the specific.
  • Developed for "CAT COPD" questionnaire. multiple choice question.
  • A left and right side label is made available for horizontal multiple choice.
• Free text field and free text (single sentence) are now allowed in score forms.
  • They cannot be included in the score calculation
• Added "Remove answer" button to public fill out for optional questions.

Changed

• Calculated questions can be hidden in public fill out.
  • Added toggle under "Advanced settings" - will not do anything if used in 'Visit Events'.
• Changed "French-Canadian" to "French (Canada)".
• Changed "Hebrew-Israel" to "Hebrew (Israel)".

Fixed

• The "Cancel" button would go missing in the study builder wizard on very small browser windows.