SMART-TRIAL updates www.smart-trial.co

Fixed

• Subject and Information events were in some situations sent out even though they had been locked.

Added

• Translations for gender selector - male, female, and unknown

Changed

• Language selector for public enrollment now show the languages in their own language

Fixed

• Randomization event status was missing in export csv-file
• Consent requirement was enforced for every single subject event, even if it was given during a previous fill out session
• Error in admin tool for correcting data event status and activation time. Two affected studies, which have been contacted.

Fixed

• Export of score-form with information text caused the resulting csv-file to have misalignment between headers and the values
• Export of score-form with missing values in the first entry caused the data-type header to be misaligned with the other headers and values

Added

• Admin tool to correction of certain data event activation times.
• Country code for Vietnam (+84) is now available

Fixed

• Question and help-text was not rendered as HTML during fill out and review, resulting in HTML being displayed as e.g.: < b>.
• Discrepancy between how the translation module and public fill out pages displayed Hebrew translation, causing the question mark to appear on the wrong side of the question text.
• Issue with query response triggering override of "Last Verified By" such that the responder would appear as the last person to have verified data within a data event activation.
• Issue that the user un-verifying an answer would be marked as the last verifier on the related data event activation.
• Saving answers on a new form would not trigger a recalculation of the verification percentage.

New Features

• Answer Not Available now has its own export code: .n
• A second type of verification is now available.
  • Functions exactly as the first type.
  • Uses a different colour so they are easy to differentiate.
  • Each verification type have their own permission.
• Process export: The export will now give you a process level export, such that all sites following the same process can be exported in one file.
• Study-level date and time format: It is now possible to specify the date format on a study level, which will determine how dates are displayed in the study. There is a list to choose from: EU, ISO and US formats with different lengths, and different delimiters.
• 'File as answer' question type has been added. It supports upload of any file type up to 10 mb, and can be downloaded by users with the export permission. The upload name can be seen by anyone with 'View Data'. This question type will not attempt to render the file in the browser e.g. images will not be displayed.

Improvements

• The query list has received an overhaul, adding several new columns such as: Data event, Site, Subject ID, Form name, and last update time.

• More extensive filtering has been added to the query list.

• Clicking a query in the query list now takes you straight to the answer with a query instead of the top of the form.

• Subject ID can be clicked in the query list, to take you directly to the subjects profile.

• Close queries is a new feature that allows open queries to be closed without a response. It does still require a comment when closing the query.

• Query icon now shown on data events in the site overview, if the data events contain an open or responded query.

• Subject ID is now shown when viewing a subjects profile.

• View button has been added to incomplete unscheduled events, allowing users with the "View Data" permission to view them.

• The score value of answers in a score form, are now included in the export with their own "SCORE" field, right next to the question answer.

• Date format can be specified on export level, will default to the study date format if nothing is chosen.

• Date validations were added to our AE module such that:

  • Date of awareness in AE can no longer be before start date.
  • Start date of AE can no longer be after 'today'.
  • End date of AE can no longer be before start date.

• Public sign up processes now have language specific links, such that each language the study supports has its own link. It is still possible to change the language when on the public sign up page.

• Image charts now supports validation rules.

• A secondary language no longer has to be 100% translated to be available in the public fill out part of SMART-TRIAL. Instead the default public sign up and fill out pages will show the primary language if translations for the selected language are not available.
  • Any potential primary language MUST have 100% translation: This means if your study was created in English, but you wish to swap primary to German, the German must have 100% translation before this is allowed.

• Added a download button to "Image as answer" question types during form review, requires the 'export' permission to download, as data is exported from the system.

Changes

• Display filter - can select which status icons to have displayed on the data events in the site overview. The icons are:

  • Answer not available.
  • Lock.
  • Open/Responded query.
  • Verification I.
  • Verification II.
  • A maximum of four (4) icons can be selected at a time.

• When building a form, new questions will be added where you are, instead of at the very end. Should result in less dragging of questions.

• Test mode no longer requires you to enter the study name in all caps, instead it is a simple dialogue box with "Yes"/"No"(Starting, stopping, etc. of the study still requires this type of confirmation).

• Any collaborator with the "Setup Study" permission can now delete forms, as long as they are not used in a process - previously it was only the form creator, which caused trouble when moving forms from study to study.

Fixes

• Breadcrumbs and menu items will be shown correctly on refresh, previously they would be presented such as: "BREADCRUMB.HOME" instead of the actual study name.
• Printing of forms containing tables would have the table expand out of the page, this has been fixed
• Validation rules would not recognize comma (,) as a decimal delimiter and therefore not trigger properly.
• Subject identifier would be missing from medication exports, if "Subject" permission was not present.
• Previously changing from multiple response to multiple choice or vice versa would delete answer possibilities.
• In the Data menu under the monitor tab, it was not possible to select data event + form + question in the filter if the user did not have the 'Setup study' permission.
• System would not allow same max and min length in free text and free text (single sentence) questions.
• Attempting to enroll a subject with an existing identifier (subject ID or e-mail) would give a wrong error message of "You have reached the maximum number of subjects allowed in a test study", now there will be an error message displaying "subject ID must be unique".
• It was not possible to respond to a query with change, if the question was a multiple response/choice and answered with Answer Not Available.
• Validation rules were not triggered correctly on duplicated forms.
• Added a loading indicator when saving a reference rule.
• Public registration link would show the default SMART-TRIAL logo despite being setup to use a custom logo.
• Action button in form review was not visible unless the user had "Verify" making it impossible to create a query.

Added

• Support for new country code for phone numbers
  • Canary Islands (+3491)
  • Gibraltar (+350)
  • Kosovo (+383)
  • Macedonia (+389)
  • Malta (+356)
  • Moldova (+373)
  • Montenegro (+382)
  • Georgia (+995)

Fixed

• Switch for enforcing Decimal Number missing on columns of type Number in table based questions
• Unable to change the permission for a very limited user-study combination
  • Two users affected with one study each

Added

• Validation rule support for image charts
• Support for Albania and Bosnia and Herzegovina to be selected as country code

Added

• Indonesian language is now available as study language

Fixed

• Consent text of processes was not translatable for processes where consent was not marked as required
• Forms saved on user profile before 2019.2 (2.11) were hidden
• The change-log in form review would not correctly display possibility values changed when the possibility contained a dash character "-"
• Registering new medication accounting was not possible on subjects that have their enrollments completed
• The externally available API resource for fetching forms would fail to return the forms for certain studies
• Forms saved to user profile would sometimes display the ID instead of the actual title

Changes

• Allow SMART-TRIAL operations team to configure database connection timeout

Fixed

• Sporadic error requiring re-submission of requests (e.g. to save form answers).

New Features

• Validation rules

  • Replaces the old min/max rules (if you had these setup, they have been transferred to the new system, but works the same way)
  • Allows for more advanced validation of inputs on date, date/time, specific time, duration, and number questions
  • Dates can be validated against enrollment date, fill out date and birth date (if chosen as subject attribute)
  • Works within a form
  • Three types of consequences/actions: Block answer, Show Warning, and Generate Query
  • See here here for more information

• Reference rules

  • References rules allow you to setup rules across forms and data events. It allows two question answers to be dependent on each other.
  • Uses the same types of consequences/actions as validation rules.
  • More information can be found here

• Verification

  • Set the name of the verification when you setup your study (can always be edited)
  • Verify / unverify: Questions, entire forms, AE reports, medication, and medication accounting
  • Partial verification of form + data event: As soon as one question has been verified
  • Full verification: When all questions in a form have been verified, and all forms in a data event. Likewise if a question gets unverified, the form becomes partially verified along with the data event.
  • Verification on a question is removed if the answer is edited.
  • Icon is visible in the site overview, on data events.
  • New permission: Verify
  • See here for more information
• Module references
  • Create references from your visit events to: Medication (IMP and concomitant), AE reports, and Unscheduled events
  • Allows the user to reference existing entries, or create new ones directly from form fill out.
  • Upon completion of a new AE/medication/unscheduled the user is taken right back to the form fill out
  • See here for more information

Improvements

• Added start and stop dates to medication list overview
• Updated our technology stack to ensure versioning support.
• Added an icon to the form builder, to more easily identify where information is missing before the form can be saved.
• Extended validation boxes will now have the password field auto selected to allow for direct password entry.
• It is now possible to duplicate forms in amendment mode

Changes

• Pressing tab during form fill out will now skip directly to the next question, instead of to the action buttons. This should allow for speedier data entry
• Changed a few success/error messages from developer to regular language
• Changed the layout in the form builder:
  • Possibilities, validation rules, show rules, and advanced options now have their own fold out menu underneath the question
  • Question text has been moved to the right of the question type
  • Have added "Module references" button next to "Add question" and "Add Information text"
• User changing their email will now be shown in SMART-TRIAL system log for admins, to enhance tracability

Fixed

• Missing site permission caused the audit log to return a 403 when filtering for data
• Question possibilities and slider texts would misbehave and not go where directed, they have been told to behave and will follow instructions.
• Help text could not be added during "Data collection" mode.
• The "upload image" button is now hidden for Information Texts during form setup
• Layout issue for queries in Internet Explorer 11