SMART-TRIAL updates
SMART-TRIAL updates
www.smart-trial.com

2.20.2

 

Hotfix

 

 

Added

  • A footer to all notification emails that indicates that it is not possible to respond to the email

Fixed

  • Exporting all event data would result in an extra row for Adverse Events in the export package
  • "custom_ae" correctly shows as an option for for export through the external API documentation

Removed

  • "ae2" no longer appears as a file export type when exporting "all_event_types" through the external API

2021.4 (2.20 + 2.20.1)

 

Minor

 

 

Added

  • Process Show Rules

    • With Process Show Rules you can setup show rules that span across forms and data events. They are process specific and requires your process to be setup. This allows you to create a show rule between a question in your very first data event and e.g. the last data event.
    • Process Show Rules can accessed from the Process list or from the left side menu via "Process Rules".
    • They have two components: 1 Criteria and 1-n 'Affected' elements
    • Criteria is the answer possibilities that have to be selected in-order for the show rule to be activated
    • Affected are the question(s) or form(s) that will be shown or hidden depending on the Criteria answer.
    • The Affected elements can be questions or entire forms by selecting "All Questions"!
    • Process Show Rules works in an OR capacity with each other, meaning if you have two Process Show Rules that includes the same Affected element (question(s) or forms)then so long as EITHER of the two rules evaluate to true, the affected item is shown.
    • Process Show Rules works in an AND capacity with Local Form Show Rules. That means, if a question has a Local Form Show Rule and a Process Show Rule on it, BOTH of those have to be true for the question to show.
    • Process show rules will NOT be editable or removable once the study has been started at the current time.
    • Please visit our help site for more details LINK
  • 'Tag' support for more question types (System admins only)

    • 'Tag' allows answer values to be presented elsewhere in the system for example in another question text.
    • Support has been extended, so it now includes the following question types:
    • Date, DateTime, Number, Slider, Free Text(sentence), Multiple Choice, Multiple Response, Yes/No
  • Added "Study Version" to the study info screen. It is a number that increases with every finished amendment.

  • Added "SITE ID" to the API resource for fetching sites.

Changed

  • Renamed "Reference Rules" left menu point to "Process Rules" and created a tab for "Process Validation Rules" and "Process Show Rules".
  • Removed the "Recruitment" and "Unscheduled events" column in the process list.
  • Added "Show rules" column in the process list, allowing you to see the number of show rules on the process, create a showrule directly from the list, and navigate to the Process rules view.
  • Question text have had their character allowance increased from 1024 to 10000.
  • 'Public registration' in the process builder has been changed to 'Public enrollment'.
  • The earliest selectable date is now 1/1/1901 in our Date pickers, due to Excel not handling Dates prior to that all too well.

Fixed

  • The new AE module was not part of the Export API endpoints.
  • Duplicate study will now correctly duplicate Process Validation Rules and Process Show Rules.
  • Filling out subject events using the External API, would allow partial fill out of the subject event, instead of requiring all mandatory questions to be answered.
  • 'Previous data event START' and 'Previous data event COMPLETED' would not correctly trigger email and SMS send out immediately if the delay was set to 0.
  • Improved load times when clicking "View Form Answers" for image charts
  • An issue where the public part of SMART-TRIAL (the no user required part), would eternally load and remove data upon refresh, if internet connection was lost during fill out.
  • Study version number would be duplicated, instead of starting at 1 in the new study.
  • Adding a Calculated question to a Score form would throw an error
  • Medication note box would show the border of the note box at the wrong place.
  • Issues with Date and Time picker in Internet Explorer.
  • Issue where "Form Answer Create Time" code in the data code file (PDF) would be incorrectly shown

2.19.1

 

Hotfix

 

 

Fixed

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

2021.3 (2.19)

 

Minor

 

 

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.

2.18.5

 

Hotfix

 

 

Fixed

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

2.18.4

 

Hotfix

 

 

Fixed

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

2.18.3

 

Hotfix

 

 

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

2.18.2

 

Hotfix

 

 

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

2.18.1

 

Hotfix

 

 

Fixed

  • Signup through external API would fail for two studies

2021.2 (2.18)

 

Minor

 

 

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