Release Notes Viedoc 4.79

Release notes updated 2024-07-19

Available on 2024-06-20 (US servers)
Available on 2024-06-26 (Europe servers)
Available on 2024-08-28 (Japan servers)
Available on 2024-09-04 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

Viedoc Coder has been updated with several new features, which are available for new studies started after the 4.79 release. For Viedoc Coder, new studies are defined as when a dictionary instance is added to a study’s scope for the first time. Later, all studies, existing and new, will be updated to use the new Viedoc Coder. This update will be communicated well in advance.

The new Viedoc Coder launches in a new browser tab and has a new look and feel for statistics on the Overview page. Access to subject data is improved which allows for easier query raising. Also, coding terms have changed to: Approve/Reject/Reset.

• Dictionary support has been updated for both MedDRA and WHODrug.
  • For MedDRA, non-current terms are shown with a warning in the results list and LLT field.
  • For WHODrug, the fields Cntr, MAH, Form, and Strength are always visible; The search result shows unique values only; The selected value is always the least specific; And ATC assignment is automatically selected if one code is present (if two or more are present, the user must manually assign the ATC code).
  • To improve searching in the dictionaries, we have made it easier to copy the text of the item to be coded, so it can be easily pasted into the search field of the coding area.
• Export of coding has rearranged columns for a better order, and all dictionary-specific items are shown together.
• You can now apply sorting to the columns, and we have removed the sequence column, providing more space.
• In the ‘Find and apply code’ section, for easier access, the comment field is now always visible.

In Viedoc Admin, the Design Revision Impact Analysis tool is introduced to let Admin users with the new system role Design Impact Analyst, see what impact a design revision will have on existing form instances before applying the revision.

A user with this role can use the new Impact analysis button on the Apply revision tab in the Design settings window to perform the impact analysis. The new revision summary column, Req confirmation, shows the number of existing form instances per site that require confirmation by site staff. The design impact analysis report can be downloaded in Excel format. Please note that before inviting a user with this role, we recommend that you read the Viedoc Admin User Guide in the Viedoc eLearning to understand when the design impact analysis report may reveal blinded information.

In Viedoc Designer, in Study settings, the following settings in a design revision can be edited: Selection View Settings, Subject ID Generation Settings, Subject status settings, eLearning settings, and Miscellaneous settings, removing the need to create a new design version for updates. The settings used are those in the latest effective design revision at a respective site.

In the Trial Master File view, in the Document properties window, a validation for the year part of the dating convention value is added, to make sure that the entered value is a valid date.

Viedoc Me has a new identity provider for user authentication, offering better support for enhanced security and centralized user management. Automatic logout will occur after a certain time of inactivity or if the network connection is lost. For more information about the automatic logout, see the Viedoc eLearning.

 The following updates to the ODM data export/import have been made to fix compatibility issues:

• Support for partial datetime, date, and time is introduced for the ODM data export. This is now the default type when exporting designs and data in ODM format. Partial dates as per the ISO 6801 standard are written up to the most detailed value available. This makes the export compliant with CDISC ODM. This is implemented in a new export version, version 4.79.
• When exporting a design to ODM, multi-selection code lists are handled as follows:
  • The checkbox item definitions are split by code list items.
  • During metadata export, checkbox ItemDef is replaced with one for each code list item.
  • For clinical data export, the comma-separated values are replaced for the checkbox with ItemData for each respective value.
  • For example, when splitting a checkbox ItemDef with OID=”CHK” and code list IDs “Yes” and “No”, the split checkbox ItemDefs will have the OIDs “__CHK__Yes” and “__CHK__No”, respectively. That is, the original OIDs and the code list IDs are prefixed with two underscore characters and separated by two underscore characters. This has been introduced to be compliant with CDISC ODM. The update is implemented in a new export version, version 4.79.
• In Viedoc Designer, checkbox items are exported as multiple ItemDefs – one for each selection value.
• In Viedoc Clinic and in the Viedoc API, in the latest export version, checkboxes are exported as separate items for metadata and clinical data. In previous export versions, checkboxes are exported as one item.
• Upon import of a design, multi-selection for code lists (checkboxes) is handled as follows: If checkbox items are found during data import, the data is combined as comma-separated values. If the checkbox data is imported as one ItemData, the structure is preserved. This has been introduced to achieve ODM-compliant designs.

Please note that if you are using the ODM format for an integration and have used the data structure version “Latest Viedoc version”, the changes to the ODM export that are implemented in a new export version will be effective in your study and might potentially affect your integration. If you instead lock the data structure version to the current version, only some of these changes will be effective in your study.

Download Release Notes Viedoc 4.79 (pdf) | Release Certificate

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