Other enhancements

Support for date questions with the format YYYY-MM-DD

YYYY-MM-DD is the most common date format used in Japan. Study designers can now use the YYYY-MM-DD and YYYY-MM-DD HH:MM format when configuring dates and time on forms in their Japanese studies, or any other studies they desire to use this format in. Partial dates are also supported in this format.

As soon as the upgrade for this release is done, the YYYY-MM-DD and YYYY-MM-DD HH:MM date and time format options will be available to study designers to support their study designs.

Support for notifications in Japanese

As a user who can set their language preference as Japanese, you can now view notifications in the language that you selected.

Apart from the already supported notifications, the following notifications are now translated in Japanese:

Subject added
Subject transferred
Subject withdrawal
Subject screening/ screen failure
Subject visit complete
Training complete (Oracle Clinical One Platform training only)
Custom notifications
User added to study
State of a site has changed
Rule re-run
Report is ready
Report failed to generate

Note:

Notifications intended for non-Oracle Clinical One Platform users, such as depot email addresses, will always be sent in English.
Oracle Health Learn course certificates and notifications for other applications are not translated.

Oracle CRF Submit: Inclusion or exclusion of blank forms in the Archival PDF output is now configurable

The Archival request type for sponsor and site users now allows for the inclusion or exclusion of blank forms in PDF output files. To control this, a new setting, Include Blank Forms, has been added with a default setting of Yes. Going forward the setting Blank Form Format will only appear when the new setting is set to Yes.

Oracle Central Coding: Dictionary Version has been removed under Coding Item Type

The Dictionary Version option that appeared under Coding Item Type in the Advanced pane when creating a form that is to be integrated with Oracle Central Coding has been removed. This option is not needed as the Oracle Central Coding system combines the dictionary name, i.e., MedDRA and the version, i.e., 24.0 into a single data point prior to sending the details back to the study. The single data point is mapped to and stored under Dictionary Name.

Dose holds can now be placed on Unblinded Pharmacist kits

Clinical supply managers can now configure a dose hold for an Unblinded Pharmacist kit. Additionally, an unblinded site user can place a dose hold for that kit during the study conduct period. When it comes to blinded site users, if there is an Unblinded Pharmacist kit that they must pause dispensation for, a notice is displayed on the screen to indicate that they should contact their pharmacist to perform this action. More details coming soon in:

Find additional information about kits

Clinical supply managers can now simplify their workflow in Oracle Clinical One Platform by locating additional information about their kits under the Study Inventory tab. An updated table within the interface provides you with new columns and details about your kit's status.

In addition to improving the management of kits for sponsor users, site users can now view kit information under the Site Inventory tab and in site-related reports after kits have been selected for a reconciliation shipment and returned to the depot. If a kit has been selected as a replacement, details of the newly dispensed kit are displayed under the Inventory Management pane.

You can also see information about a kit under the Inventory Management tab after changing the status of a kit to Misallocated and updating its details. Once the status of a kit has been changed to Misallocated, a new notification is sent to subscribed users.

If you choose to update a kit's status to Not Dispensed to Subject, the details will appear under the Inventory Management tab and the kit will be removed from the subject's history. When a site user updates the status of a kit to Not Dispensed to Subject, a notification is sent to users who are assigned permission to receive it.