SMART-TRIAL updates www.smart-trial.co

Fixed

• Site overview was not loading for a single site/study after an advanced amendment
• It was possible for a user without a specific permissions to fill out an AE field (saving the AE was still prohibited)

Added

• Print for AE reports is now supported!

Fixed

• Issue with exporting subject ID as part of medication or adverse event (original AE module) exports, would show .b instead of the actual subject ID
• Would get logged out of the system after 45 minutes if user had clicked on "logout" and then logged back, in the same browser.
• The new AE module did not ignore questions hidden by show rules, when evaluating whether the 'Sign' button should be active.

Fixed

Restarts of individual instances of the Backend component related to email and SMS send-out for two studies

Added

• Support for Russian language

Fixed

• Sporadic restarts of the individual instances of the Backend component leading to requests having to be retried
• Intra-form validation rules (validation rules between date questions within the same form), were not evaluating on the referenced question in public fill out for subject events
• Adding Information Text while the currently selected question had validation rules would show a warning that validation rules would be removed, despite the validation rules were still valid
• Data entered in table-based questions was not cleared when the question was hidden by a previous show rule
• Notifications for being added as a collaborator would show up twice in the notification list once logged into SMART-TRIAL

Fixed

• Saving form 'Translations' for a secondary language would consistently fail across all languages

Fixed

• Previewing forms from before 2.11 would fail with an error message saying to try again

Main feature

The big feature in this release is the new customizable AE module. It allows you to create an AE form specific to your study and use it to register AE Reports, with all the benefits from our current AE module. All new studies will use the new "Adverse Event Module". Existing studies continues with the "Original AE module".

It will be possible to manually transferring data from the original AE module to the Customizable AE module, please contact support@smart-trial.co

The new AE module comes with quite a few changes that are summarized below. For the full write up on how to create an AE form click here

Setup

• You can setup your own AE form from scratch or use one of our three templates as a starting point.
• Three types of AE report flow, that determines how involved the sponsor is:
  • Always involve sponsor (on both AE and SAE)
  • Involve sponsor on SAE
  • Never involve sponsor
• Specify WHO can fill in a given question, tied to the collaborator permissions "AE reporter", "Investigator AE", and "Sponsor AE"
  • Reporter
  • Investigator
  • Sponsor
• Specify WHEN a question is mandatory, select between the steps available in the selected AE report flow or never and
• First two eligible questions will be used as columns in the AE/SAE Report List (see help site)

Fill out

• Investigators and Sponsors are notified when an SAE is reported, and when it is their turn to take action
• Use the buttons placed on each step in the AE report flow to continue through AE report.
• Create queries on AE fields as you would a regular form
• Only users with Sponsor or Investigator permission are able to respond to queries on Investigator or Sponsor fields.

AE report list

• Each AE report now gets a unique AE Report ID within the study in the format XXX-YY, where X is a study wide AE counter, and Y is a counter for the number of AEs on the subject.
  • E.g.: 001-01, 002-01, 003-02
• The first two eligible questions in the AE form will be used as two columns in the AE report list. Therefore if you wish to have e.g. description of event visible in the report list, place the question as one of the first two questions in the AE form.

Improvements

• Subject Authentication view got some updates
  • Can now use custom logo
  • Increased clarity on which study the user is accessing

Changes

• Form list: Removed 'Score form' and 'Inclusion form' columns and replaced them with a 'Settings' column.
• Changed the colour of toggle buttons to SMART-TRIAL orange where they were yellow.
• Changed the colour of checkboxes in collaborator menu from yellow to SMART-TRIAL orange
• Can select between three types of forms when creating a form.
  • Form (default)
  • Image Chart
  • AE form
• Text changes
  • 'Study Webhooks' have been changed to 'Study Notifications' in the left side menu
  • 'Webhook' has been changed to 'notification' in the Study Notification creation/update view
  • 'Webhook' has been changed to 'Study Notifications' in the permission view
  • 'Process Status' —> 'Subject enrollment status' in the Data menu
  • 'Answer Links' —> 'Status' in the Data menu
  • 'Answer links sent' —> 'Questionnaire fill-out links sent' in the Data menu
  • 'Answer links waiting to be sent' —> 'Questionnaire fill-out links not sent' in the Data menu
  • 'Sign Off' has been changed to 'Sign Off Enrollment'
  • Randomisation dialogue text has been updated.
  • The collaborator permission "AE" has been renamed to "Report AE" to clarify what its function
  • patientId in the export has been changed to subjectId in the regular export. In the API export we supply both

Fixes

• Inclusion/exclusion form did not evaluate properly if an answer had been marked as "Answer Not Available"
• 'Translation' menu was visible despite users not having "Setup Study" permission
• Accounting date was not included in the medication export
• Show rules would sometimes misbehave if the qualifier question was marked "Answer Not Available" and show the dependent question.
• Calculated questions did not respect the number of decimals specified.
• 'Leave' button was missing an arrow in the "Review Answers" footer
• When creating show rules, possibility texts were always show in English despite the study/question using e.g. Danish (for yes and no questions)
• Dynamic table was not cleared correctly when changing question type, resulting in "+ADD ROW" being present on other question types
• Changing language in public fill out, did not correctly update validation rule text. Sometimes causing it to change language half way through
• When creating a new site users had to select location twice
• The standard email text sent out for subject events was missing some spaces

Fixed

• Subjects were unable to upload files to questions during public fill out when the first data event was of the type Visit

Fixed

• Decimal values for dose in medication export where in some cases exported as dates
• Issue with links to public fill out shared through social media platforms, being redirected to the login page of SMART-TRIAL

Changed

• Enabling SMART-TRIAL admins to switch multiple activation off on data events after a study has started under certain conditions

Fixed

• Issue with date question validation rule not triggering correctly when editing answers and the reference date is the fill-out date