Confimedis Platform v3.19.0

Features

• Forms: Assignment matrix next to the form editor
  • The Assignment matrix can now be pinned next to the form editor, where changes are saved right away and a click on a form opens it, so that forms can be assigned to events while they are being edited.
  • While the matrix is pinned, the sidebar collapses to its icons, and the left column of the Forms module (holding either the list of forms or the pinned matrix) can be resized by dragging its border.
• Forms: Comments on forms
  • Events, forms, sections, and fields can now be commented on in the new Comments tab of an element, which opens through the Comments action of the element in the form editor and in the list of forms, so that open points can be noted and discussed in the team.
  • A comment can be replied to and marked as Resolved along with the reply, while the whole discussion is kept as history and a resolved discussion is collapsed.
  • Open comments are shown as a badge on the element in the form editor and counted per event and form in the list of forms and in the pinned Assignment matrix.
  • The new right Comment on forms allows commenting (included in the right to edit forms), while all users can read the comments and reach the Details and Comments of an element from the form preview.
  • The new notification Comment added informs everyone who may comment on forms when a comment is written or answered, once it is enabled in the project settings.
  • The author of a comment can still edit or withdraw it as long as nobody has replied to or resolved it.
  • Comments are part of the export and import of a project (under Further data), including their replies, which an import attributes to the importing user.

Improvements

• Subjects: The options of a subject, both in the subject list and when the subject is opened, now offer its Audit trail, which shows the changes to the subject itself, such as its ID, site, study arms, status, and lock.
• Subjects: Sections and fields that depend on a condition or are calculated are now framed with a dashed border during data entry and in surveys, as in the form editor.
• Subjects: A repeating section that is shown as Data matrix now carries its title and its descriptive texts above the table and only numbers its rows, instead of repeating the title in every row, and offers the actions of a section, such as its Comments, in the form preview.
• Users: The setup of two-factor authentication now shows the secret key next to the QR code, so that it can be entered manually in an authenticator app.
• General: The browser tab now names the active module in front of the project, so that several open tabs can be told apart.
• General: The app can now be operated by keyboard and screen reader throughout: tabs, cards, and menus can be focused and activated with the keyboard, the focus stays within an open dialog or slideover, Escape closes the topmost dialog, menu, or slideover, icon buttons show their name as a tooltip, and dialogs, notifications, inputs, and list entries carry accessible names and states.
• General: The sidebar can now be collapsed to its icons with the arrow that appears when hovering its right border, and shows the names of the modules as tooltips while collapsed, which also happens on its own on narrow screens such as tablets in portrait orientation.
• General: A slideover now focuses its first field as soon as it opens, such as the ID of a subject, the name of a folder, the title of a new query, or the name of a calendar entry, so that typing can start right away.
• General: Breadcrumbs of deeply nested paths now keep their first and last entry visible and collapse the ones in between into a menu, which lists the whole path with a badge counting the hidden levels, while breadcrumbs and the entries of hierarchical lists can now be operated by keyboard.
• Forms: The Assignment matrix now shows the event groups above their events and marks repeating events, forms, and sections with an icon.
• Forms: Text fields for numbers now show their data type and value range below the input (such as Whole number, >= 0, <= 100), as on the printed form.
• Reports: The Tabular overview now offers a Search above the table, which narrows it to the rows containing the entered text in any of their columns.
• Reports: Long texts in tables now take at most three lines and show their full text when hovered, so that the table stays readable on smaller screens, while questions and section texts are shown without the characters of their formatting (such as the asterisks of bold text) in tables, chart titles, and the audit trail.
• Documents: The structure of the eTMF now consists of folders: TMF Reference Model in the Add menu creates the zones, sections, and artifacts of the CDISC TMF Reference Model (version 3.3.1) as folders, which can be adapted freely and complemented by structures of your own, while the Hierarchy view shows any folder with everything below it as a tree and existing documents have been moved into the folders of their artifacts.
• Documents: The list of documents now offers a Search that finds folders and documents by name within the current folder and everything below it, shows the numbers of subfolders and documents of a folder across all levels, and provides Download in the menu of every folder and document.
• Documents: The download of documents now offers an Overview, a CSV file that lists the downloaded versions with their path, status, and last update and can also be saved on its own as an index of the eTMF.
• Export: The export now distinguishes Folders and Documents under Further data › Documents, so that the folder structure of a project, such as an adapted TMF Reference Model, can be exported and imported into another project without its documents.
• Calendar: Entries that last several days are now shown as one bar across their days, and each day shows as many entries as fit into its height, with the number of further entries below them.

Bug fixes

• Forms: Fixed an issue where an event could no longer be moved into another group by drag and drop once an event had been opened.
• Forms: Fixed an issue where an event dropped onto the heading of a group was placed before the last event of that group instead of at its top.
• Forms: Fixed an issue where the function date in calculations and conditions returned the date in UTC, so that it already showed the next day in the evening in the Americas and still the previous day shortly after midnight in Europe.
• Forms: Fixed an issue where a setting changed right after typing in the slideover of an element, such as the data type right after the variable name, was occasionally lost.
• Notifications: Fixed an issue where the notification settings of a user were not respected for every type, so that emails pointing out unread messages (without their content) were sent although they had been turned off, while notifications about new subjects and scheduled events were not shown in the app when only the app had been chosen.
• Notifications: Fixed an issue where a notification about a scheduled event without a configured time could be missed depending on the time zone of the study, which is now sent as soon as its day begins.
• Users: Fixed an issue where the invitation could not be resent to a user who is managed centrally in the administration.
• Users: Fixed an issue where changing the email address of a user who had not yet accepted the invitation sent no invitation to the new address, while the link of the first invitation no longer worked.
• Subjects: Fixed an issue where a number containing a space or other characters, such as 12 500 in a field of the type Whole number, was cut off without notice at the first space or other character (here saved as 12), which is now rejected with an error message, as are numbers whose separator may group thousands (such as 1,500, which was read as 1.5) and whole numbers too long to be stored exactly, while all other inputs and imports of the application now read numbers in the same strict way.
• Subjects: Fixed an issue where leaving a form with unsaved changes through the back button of the browser, a search for another subject, or Escape in the table view did not ask whether to save or discard them, so that the previous form stayed open under the newly selected subject or form.
• Surveys: Fixed an issue where switching the language of a survey translated only its questions, while its buttons and hints stayed in the previous language until the page was reloaded.
• General: Fixed an issue where logging out, also automatically after a period of inactivity, ended the sessions of the same user in all other browsers as well, so that logging out now ends the session of the current browser only, as expected, while every other session still ends automatically after its own period of inactivity.
• Reports: Fixed an issue where decimals with more than three decimal places were rounded to three in reports, on printed forms, and in the CSV export with Prefer translated texts, which now show them in full.