Clinical Trial Shared Data

The Clinical Trial Shared Data entity enables users to consolidate common details about Clinical Trial Authorization applications (CTAs).

The Clinical Trial Shared Data entity is created and maintained at the product family level, making the information available for association with CTA, CTR and IND application events. Upon associating the Clinical Trial Shared Data with a CTA, CTR or IND application event, the same information applies to all event-countries associated with the event without the need to continually re-enter the same information on the application for each event-country.

Clinical Trial Shared Data is identified by the protocol code number. You can associate the Clinical Trial Shared Data to more than one CTA, CTR or IND application event. However, you can only assign one Clinical Trial Shared Data entity to an event for CTA applications.

For an application with no products, created under a product family:

— You can associate one or more Clinical Trial Shared Data entities with an event that is associated with an IND or CTR application.

— You can associate only one Clinical Trial Shared Data entity with an event that is associated with a CTA application.

— You can associate the same Clinical Trial Shared Data with more than one event.

— You cannot associate Clinical Trial Shared Data with a closed event.

— You cannot disassociate Clinical Trial Shared Data from a closed event.

After all the products are disassociated from the application, on the CT Shared Data field is available on the Event page with the data from the product family application was created for.

If an orphan application is created via Create Application wizard, no CT Shared Data values will be displayed on the Event page until at least one product is assigned to the application.

If you have permissions to view the product family, you can also view information on the CT Shared Data tab.

If you have with at least Write for the event, you can associate or disassociate the CT Shared Data.