SMART-TRIAL updates www.smart-trial.com

Hotfix

Added

• New EQ-5D-5L languages:
  • Dutch (The Netherlands)
  • Italian (Italy)
  • French (France)

Hotfix

Fixed

• AE reports will no longer be locked when an enrollment is 'Signed off'.
• The 'File error' warning (related to excel files that cannot be generated due to too many columns) would appear on the "Study Overview" exports.

Hotfix

Fixed

• When rescheduling an activation time, the expiration time would not move together with the activation time. This would result in data events potentially expiring before they activated.
• Removing a form from a data event in amendment mode, would prevent edits to already collected data in the data event. Additionally the data event could no longer become "completed".

Hotfix

Fixed

• The entire export would fail, if the Excel file could not be generated. Now the Excel file will appear as not available, but the CSV will be downloadable. The Excel file can fail if the data set has more than 16384 columns, as that is the max allowed in Excel.

• Form show rules would not always work correctly in Single Question Fill Out forms.

Hotfix

Fixed

• Comparing a date with a datetime in a process validation rule would assign "00:00" to the date, sometimes resulting in faulty validation rules. In this case, the validation rule will now only compare the dates, and ignore the time component.

• The medication export would sometimes get an extra row of headers inserted near the bottom of the export.

• The sticky columns in the site overview would in some cases (many subject identifiers and enrollment sign off) on small screens make it difficult to see the data events.

• Older Suite studies would have a warning under the "public introduction text" field, saying it is required, despite being disabled.

Minor

Added

• New Add-on: Connected Devices

  • Send data from wearables and other devices directly to SMART-TRIAL via the new Data API. See documentation HERE.
  • Can for instance be used for: Heart Rate, Activity data, continuous glucose monitors, and GPS data.
  • Create and manage schemas, send data records, fetch data records, and count data records.

• Korean as a study language.

Changed

• Subject Identifiers and 'actions' are now sticky in the site overview, and will scroll with you. No longer lose track of which subject you are working on. Remember you can select which subject identifiers you want shown in the overview using "Display Filters".
  • An info-box will appear when scrolling to the right, to show data events are hidden.
• The "Select All" possibility selector under 'Criteria' in Process Show Rules, will now change into a 'Unselect All' if all possibilities are selected.
• SMART-TRIAL admins will be notified if a user is locked out of their account. Users must still write to support to have their account unlocked.

Fixed

• The enrollments resource on the external API would return "Now" for timestamps that should have been null.
• eConsent event was displayed as a selectable data event under the "Criteria" section of process show rules.
• Multiple Choice type question would sometimes not show up in subject fill out, if a show rule was hiding several of the questions. They will now correctly be presented.
• The save button was enabled when creating a Cases subscription, even if mandatory fields had not been completed.
• The counter used for creating automatic subject ids (e.g. study incremental) would get locked in case any validation error occurred when trying to save a subject. This would result in creation of new subjects being prevented.
• An error would occur if "Public Introduction Text" was disabled and re-enabled for a Cases study.
• The notification menu had some unwanted styling and elements added to it, that has now been corrected.
• In our API documentation "Offset" was shown to be mandatory, when it is actually 'optional'.
• For eConsent the QR-code/Link page would show an email link, even if email was not selected as a subject attribute.
• Mobile number was not correctly set to mandatory as default for studies with eConsent.
• eConsent document upload has been restricted to only support pdfs as intended.

Removed

• Google Analytics were removed from the front end.

Hotfix

Fixed

• In certain cases, if a public sign up failed due to field validation, the subject would get deleted, but the enrollment remain. This will later cause exports to fail.

• Exporting in a specific study, due to the above

Hotfix

Fixed

• SMS send out would fail for eConsent events (not the OTP) in case the SMS addon was not selected. A dialog will now pop up if "Send as SMS" is selected, asking if the SMS addon should be enabled.
• The error message "You have not filled out all the required questions in the form.." would not disappear in public fill out, after completing the mandatory questions.
• Solved a number of visual bugs in the fill out views (such as lack of spacing/padding).
• For certain study primary languages, the export would output ".b" when exporting "Text Possibilities" despite data being recorded. Affected studies have been contacted.

Hotfix

Fixed

• Validation of numeric questions would fail if the number started with "0" or ended with "0" after decimal point

Minor

Added

• New add-on: eConsent

  • Upload your consent document in pdf format.
  • Subjects can sign the document remotely or on-site.
  • Investigators are notified when a document is ready for their signature.
  • Keep track of all consents in the study, from a central overview.
  • Please read our help site article for a full write up, and then contact us if you have any questions or are interested in using it.

• Both the External and Subject API now fully supports uploading and downloading of images and files.

Changed

• New look for filling out "Single Question Fill out" for subject events using mobile, to allow ensure buttons + 1 line of question text + 5 x one line possibilities can be seen without scrolling on mobiles of iPhone 8 sizes and above
• Changed "Product" to "Subscription" and updated the texts in the study builder flow.

Fixed

• The Site Overview will no longer scroll to the top after opening a data event side bar.
• The data event "Completed Count" was note always correct.
• 'Report Event' for AE reports button would not get enabled if a table question using a number column was marked as Answer Not Available.
• It was possible to add medications and report Original AE reports on completed studies.
• The Study Notifications "Additional Information" was missing a few attributes.
• An export with an Image Chart, would show '.b', instead of '.h' in cases where it shouldn't.
• In the External API the 'Multiple Choice' question type would accept several possibilities, as if it was a 'Multiple Response'. That is no longer the case.
• As a preventive action, we applied the same fix to other single possibility type questions.
• In the External API the "DataEventRegistration" model would miss "AnswerNotAvailable" if it was set to false. Now it will show both if false and true.
• Sorting by "name" in the process list did not work entirely correctly.
• Audit log: Attempting to "Go to" for Unscheduled Event form answers, with no answers there would show an error page (404).
• "Show as dropdown" was editable during test mode for Multiple Choice/Response questions, which could result in nothing being shown. This has been disabled, as that sort of changes is only allowed in amendment mode or building mode.
• The External API would accept "AnswerStrings" as valid for possibility type questions, where it should only have accepted "possibilities".
• For Image Charts, any question hidden by a show rule, would show the "Question is hidden" text, despite the question being shown.
• "Version" would show incorrectly in the audit log for Image Charts.
• The External API would accept requests where possibility type questions had both a possibility selected AND Answer Not Available. It will now correctly reject it.
• The External API would accept a blank space as enough reason for change when editing a question answer. It will now require a bit more of a reason.
• The audit log would have a "Go to" for unlocking randomisation and information events.
• Validation rule "Warnings" would not show properly when reviewing a form, it is now in full display!
• Medication export text fixes:
  • More than three months since start had some text missing
  • Medication Name was shown as "Trade Name"
• For "Single Question Fill Out" forms, the 'Form Introduction text' would not be presented, it will now correctly have its own screen.
• Changing the Primary language of a study, would remove all other languages.
• The audit log would throw an error, if the study owner edited the permissions of a pending collaborator.
• Discontinue events will now correctly allow all forms to be filled. Would previously stop after the first.
• The External API now correctly validates decimals for decimal number questions.
• Changing from e.g. Cases to Suite, would not correctly show an error indicating an AE form template must be selected (so long as AE add-on is enabled).
• The "Edit Answers" button would show as enabled for completed studies, despite the action not being allowed.
• The audit log would struggle if a form was edited, in a study with several languages enabled.
• Boolean variables in the external and subject API showed incorrectly in the online documentation as "Object". Now they show correctly as "Boolean".