OpenData Clinical allows you to create a clean and compliant directory of clinical trial sites and investigators in your Vault by linking Institution-type Organization object records and Investigator-type Person object records to OpenData Clinical records.
Note: Veeva Support must enable OpenData Clinical in your Vault. OpenData Clinical is part of the Clinical Operations application family. You must have Veeva CTMS and/or Veeva eTMF to use OpenData Clinical. Contact your Veeva representative for more information.
Configuration Overview
- Create and configure Institution-type Organization object and Investigator-type Person object page layouts.
- Add the OpenData Clinical Details application section to the page layouts.
- Hide OpenData Clinical-managed fields.
- Add the Data Change Request object section to the page layouts and prevent record creation from the section.
- Add the Controlled by OpenData Clinical column to both the Location section on the Institution-type Organization page layout and the Contact Information section on the Investigator-type Person page layout.
- Add the Data Change Request Lines object section to the Data Change Request page layout.
- Optional: Set the Data Change Request Atomic Security action to Execute on the necessary lifecycle states for the Person and Organization lifecycles.
- Optional: Configure a Data Change Request tab under the Global Directory tab.
Hiding OpenData Clinical-Managed Fields
OpenData Clinical manages various fields on Institution-type Organization and Investigator-type Person records. These fields are read-only in the OpenData Clinical Details section, and users cannot edit them.
While these fields are read-only in the OpenData Clinical Details section, users can attempt to modify these OpenData Clinical-managed fields when they appear in other sections on the Institution and Investigator page layouts. However, Vault displays an error message when users attempt to save the changes made to the OpenData Clinical-managed fields. To avoid error messages, remove these fields from the page layouts or use layout rules to hide the fields.
Note: The Organization object requires the Organization field, and the Person object requires the Last Name field for the page layouts. Admins cannot remove these fields from the page layouts. We recommend using layout rules to prevent users from attempting to edit these fields.
Related Permissions
You can complete all steps in this article and the Using OpenData Clinical article with the standard System Admin or Vault Owner profile. If your Vault uses custom security profiles, your profile must have the following permissions to work with OpenData Clinical:
| Permission Type | Permission | Controls |
|---|---|---|
| Security Profile | Objects: Person: Investigator: Read, Create, Edit | Allows users to view, create, and edit Investigator-type Person records |
| Security Profile | Objects: Person: OpenData ID: Read, Edit | Allows users to view and edit the OpenData ID for Person records |
| Security Profile | Objects: Person: Data Change Request: Execute | Allows users to create Data Change Request submissions for Person records |
| Security Profile | Objects: Person: OpenData Clinical Details: View | Allows users to view the OpenData Clinical Details application section on Person records |
| Security Profile | Objects: Organization: Institution: Read, Create, Edit | Allows users to view, create, and edit Institution-type Organization records |
| Security Profile | Objects: Organization: OpenData ID: Read, Edit | Allows users to view and edit the OpenData ID for Organization records |
| Security Profile | Objects: Organization: Data Change Request: Execute | Allows users to create Data Change Request submissions for Organization records |
| Security Profile | Objects: Organization: OpenData Clinical Details: View | Allows users to view the OpenData Clinical Details application section on Person records |
| Security Profile | Objects: Data Change Request: Read, Edit | Allows users to view and edit Data Change Request records |
| Security Profile | Objects: Data Change Request: Cancel Request: Execute | Allows users to cancel Data Change Request submissions |
| Security Profile | Objects: Data Change Request Line: Read, Edit | Allows users to view and edit Data Change Request Line records |
| Security Profile | Objects: Contact Information: Read | Allows users to view Contact Information records |
| Security Profile | Objects: Location: Read | Allows users to view Location records |