Other enhancements

Create a non-dispensing randomization visit outside of its visit window

Study designers can now create a non-dispensing randomization visit and specify whether a subject's randomization can occur outside of the randomization visit window. To do that, a new setting is introduced on the Create Randomization Design dialog, called Allow Randomization to Occur Outside Visit Window. For that setting, a study designer can select either Yes or No, depending on what they want site users to do.

Figure 14-6 How a study designer configures the new randomization setting

As for site users, if this setting is enabled in the study, they can start and complete a non-dispensation visit outside of its visit window. On the Subjects page, when they begin the randomization visit of a subject outside of the visit window, a confirmation dialog is displayed, asking them whether they want to start the visit or not.

Update a treatment arm's name after study design approval

Whether you need to update your adaptive randomization design or the team made a typographical error, as a study designer, you can now update a treatment arm's name after the study version has already been moved to Approved.

In Draft, once you change a treatment arm's name and move that study version to Approved, the change is reflected in multiple product areas:

• In all study versions in Testing, Training, or Production.
• In the Randomization List, Kit Dispensation, the Titration Summary (Unblinded), and Subject Visits (Unblinded) reports.
• In an open label study or when a user performs a Code View or Code Break on a subject.

Blinded kit expiration dates now visible in the user interface

The blinded expiration date is now displayed for site users to see in the user interface. Using the blinded lot expiration date minimizes impact to existing studies and is helpful to have visibility when verifying kit expiration dates.

On the Site Inventory tab, the expiration date for a blinded kit is displayed to the right of the Status column.

The column for the expiration date will be hidden if the study does not have any blinded lots.

New reports in the application available in Japanese

Certain reports in the application are now available in the Japanese language. From now on, when you change your language preference to Japanese, the following reports will also be available in the same language:

• Subject Data Extract (in all formats: CSV, XPORT, and CPORT)
• Subject Visits (in all formats: CSV, HTML, and PDF)
• Kit Dispensation (in the HTML and PDF formats)
• Subject Queries (in all formats: CSV, HTML, PDF)
• Study Design (in the HTML and PDF formats)

Browse the rest of our Japanese documentation here: Oracle Clinical One Platform and Oracle Clinical One Integration Hub in Japanese.

Dedicated user guide for study designers

With each release, the study design component of our application becomes more powerful and more complex, too. To further help study designers get the quality user assistance that they need, we have created a brand new and improved user guide for study designers. In there, they can find step-by-step instructions for every task, organized by category, whether it is related to visits, forms, questions, code lists, or dispensation.

Previously found in the Information for CRO and Sponsor Users publication, almost all of the study design tasks and conceptual information are now part of the Study Designer User Guide.

Note:

Step-by-step instructions for the advanced study versioning techniques remain in the Information for CRO and Sponsor Users publication.