SMART-TRIAL updates www.smart-trial.co

Added

• A new product type: Cases
  • Cases is perfect for collecting data ad-hoc without follow ups, such as: usability, safety, off-label use, and ad hoc incident reporting.
  • Recommended for: Clinical Performance Reporting, Prospective PMCF Registry with no Follow-Up, and Safety and Vigilance Reporting.

Changed

• The study builder will now hide the left-side stepper on smaller screens, during product selection.

Fixed

• Saving translations would in some cases fail, making the entered translation disappear upon reloading the translation module.
• Fetching large forms with many minor versions, would sometimes cause the API to run out of memory
• An issue that prevented old form versions from being duplicated and saved to profile.

Added

• Integration with Azure Key Vault for retrieval of security critical elements on data export components
• UAE country code (+971) for phone numbers of users and subjects

Fixed

• Footer of emails send out for subject and information events would contain "undefined" instead of the study name
• Unable to export data due to incorrect permission requirement

Changed

• "Re-schedule" renamed to "Schedule" for data event activations WITHOUT an activation time set.

Added

• Integration with Azure Key Vault for retrieval of security critical elements on backend components

Fixed

• Original Adverse Event report export missing header for "Adverse Event Report Id"
• Two scrollbars would be present in the form list view
• Form list, ae list, ae template list would not use the default value of 25 for pagination, and would reset to 10 on subsequent views
• Filled out by and last updated would show the icons, and no values when changing between forms during fill out.

Fixed

• Site overview would not show subjects for certain studies using randomization
• Using "Resend Form Link" would not resend if mail/sms was already successfully sent out
• Export of number-columns in table-based questions would appear as .b
• Subject events using "Do not send" and manual activation would have an option to "Send Form Link" despite no link being sent

Added

• SMART-TRIAL Products & Study builder

  • With the introduction of SMART-TRIAL products we have changed the study builder. It is now a wizard with 6-8 steps depending on your selections.
  • First select which product you wish to use (eCRF, ePRO, Suite, Survey, Cases).
  • eCRF for instance, only allows for visit events to be created, and is meant for studies with no direct ePRO.
  • Next you can select between a number of add-ons, some being included with the product you select as a standard. Depending on what you select here there will be a number of configurations later.
  • For a full write up of the add-ons and the study builder please see here

• Export directly to Excel format.

  • When exporting any data that comes in a CSV, an additional file in xlsx format will be created and available for download. The xlsx file can be opened directly in Excel without importing.

• Form versioning

  • Forms will get a version number consisting of a major + minor number (m.n) e.g. 1.3
  • All forms start with the version 0.1. Starting a study all forms will be set to version 1.0
  • Saving a form, i.e. pressing 'Save' will increment the MINOR number, e.g. from 0.1 -> 0.2.
  • During amendment mode you can increase the MAJOR number, the button is available in the forms list.
  • Previous form versions will be available in the forms list with limited functionality, e.g. you cannot edit them.
  • Only the newest form version is active in the study, so you cannot have version 1.0 running on one site, and version 2.0 on a different site. That will still require two separate forms.
  • Existing forms will have their form version set to the 'Study version', so if forms are printed after the release, the form will be the same as before the release.
  • The current form version will be visible when filling out a questionnaire. When reviewing a questionnaire the current version of the form is visible along with which version the questionnaire was last saved with.
  • Form version can be included in the export.
  • For more info please visit the help site

• Reschedule data event

  • Users with the "Reschedule" permission can now change data event activation times!
  • Activation time can be moved into the future or set to "now".
  • Two application options:
  • 1) 'Apply to current'
  • 2) 'Reschedule subsequent data events'
  • E.g.: If you add +7 days to an activation time, and select 'Reschedule subsequent data events' all other activation times for that enrollment will have +7 days added.

Improvements

• Stratification for our randomization module
  • Sites can be used as a factor or ignored. If ignored it creates a central randomization list, if used each site gets their own randomization list.
  • Select a number of possibility questions and use them for stratification, e.g. 'Gender' or 'Smoker' to segment your study population.
  • Selecting a question will use ALL the possibilities as strata. That means, if you want to stratify based on a Yes/No question two strata will be created. If you use a multiple choice with four possibilities, four strata will be created. Should you select both a Yes/No AND the multiple choice question the system will create product of possibilities as strata (2 x 4 = 8 strata).
• 'Do not send' option for subject events has been added. Along with that we remove the restriction that "email" must be a mandatory attribute to use subject events.
• Slimmed down the 'Public' part of SMART-TRIAL to improve load times for subjects accessing questionnaires via SMS or email links.

Changed

• Reason for change has been extended to include saved answers in incomplete data events and incomplete forms. This means that if already saved data, in a partially filled form is edited during fill out, a reason for change will be required for the edits, as the already saved data is part of the CRF.
• Randomization records can consistently be added to a study by increasing 'Target Inclusion'(TI) during amendment mode. Upon finishing the amendment, the difference between the new TI and the old TI will be created and distributed among sites/strata/groups. E.g. if old TI was 200 and new TI is 400, the system will generate 200 new randomization records.
• *Report AE' button has been renamed to '+ADD AE/SAE', to avoid confusion, as the button does not report any AE/SAE to the relevant authorities.

Fixed

• Slider min value would not validate correctly, and insist the min value had to be smaller than the max, even when that was the case.
• Verification tooltip would shown when hovering the action buttons during 'Review Form Answers'.
• Trying to log out when viewing an AE report would result in numerous dialog boxes being shown.
• Creating a subject would create two repeated entries in the audit log for 'enrollment' and 'medication.
• Changing a question type from 'Free text' to a multiple choice type during building of a form, would result in show rule values not being shown properly until a refresh.
• 'Missing Data' icon would sometimes not get set correctly on the data event after an amendment.
• Accessing the audit log after editing a pending collaborator would result in a 404
• Longer study names would overlap other elements on the public registration page on smaller screens (e.g. mobile).
• Exporting with 'Text possibilities' would cause SCORE values to be set to 0
• It was not possible to respond to a query on a dynamic table, if it contained a date column
• Randomization records were exported in an incorrect order.
• Medication references showed the database id in the audit log, instead of a more readable translation.
• Exporting Adverse Events, or 'All event data' in studies using the new AE module would sometimes fail.
• Changing ones email to an email with a pending invitation would result in two collaborators appearing in the list.
• Dates shown in the medication list would differ from dates shown when viewing the medication, if the local time zone was behind/ahead of the database time zone.
• 'Study Start' and 'Study Test" (start/stop of test mode) were not part of the audit log.
• Unable to edit old forms due to missing "Form Type".

Added

• Migration for a specific study, that moves table question answers into adverse event reports

Fixed

• Double formatting of adverse event date fields presented in the adverse event lists.

Added

• Added a search field for sites in the 'add collaborator' dialog box, to aid with finding a specific site in studies with many sites.
• Added pagination to the 'add collaborator' view to avoid overloading the view in case there are a lot of sites.
• Option for SMART-TRIAL admins to stratify randomization by site, answers to questions or a combination of the two - previously only site stratification was available.

Fixed

• Saving medication entries with invalid values for Dose Unit and Frequency was possible
• Audit log "View Difference" view for process showed AE entries

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