SMART-TRIAL updates www.smart-trial.com

Hotfix

Fixed

• Unable to access incomplete unscheduled events with a file uploaded
• Using the button "Update and Continue" during fill out of a data event would result in an error in certain cases

Hotfix

Removed

• Removed "Form Answer Create Time" and "Form Version" as selectable export attributes for the Original AE module exports, as it would cause a mismatch between headers and data in the export. The original AE module does not use forms, why the two attributes are not applicable.

Hotfix

Changed

• Subjects can no longer change the form language during public fill out. If they for instance selected their preferred language to English, they will not be able to change the language when filling out forms to e.g. French. Clinical personnel can still change the subjects preferred language by 'edit subject'.
• Minor changes to the EQ-5D-5L form.

Added

• New language: French (Switzerland).
• Support for EQ-5D-5L (French for Switzerland).

Hotfix

Fixed

• Tagged values would not show up unless in combination with a multiple choice/response question
• During Subject fill out, Questions did not show up based on combination of form show rule and process show rule

Removed

• Trigger "On Data Event Status Change" for study notifications was removed

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

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

Hotfix

Fixed

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

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.

Hotfix

Fixed

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

Hotfix

Fixed

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