Managing the Person & Organization Objects (Clinical Operations)

You can use the Person object to associate a person’s information with documents, while the Organization object lets you associate an organization with documents. Using these objects, rather than a custom picklist or text field, provides more robust functionality for filtering, searching, and reporting. This makes it easier to reuse documents like CVs, medical licenses, lab certifications, and other TMF content that stay the same for a single person or organization across many trials. On your study personnel’s Person object records, you can set their Study Role and Contact Information.

Create and Edit Organization Records

You can create and edit Organization records from Global Directory > Organizations, Business Admin > Organizations, and from within a related object record, for example, Study Organization and Study Site Organization records.

  1. Click on the Create button or click into an existing Organization record and click Edit.
  2. If creating a new Organization, select an Organization Type in the dialog and click Continue.
  3. Fill in details about the Organization.
  4. Optional: Click on the binoculars icon in the USN field to open a dialog to search for and select a Research Site Name with a valid USN (Universal Study Number). Your selection here will automatically populate and lock the Organization field. Clear the USN field to unlock the Organization field.
  5. Click Save.

Vault includes an orange “connected” icon (Connected Icon) in the header of the object record details page for all Organizations that use SiteVault and have a valid USN value. This icon indicates that you can transfer documents and data to that site’s target Vault via Veeva Site Connect.

Promote Person to User

You can create a user record for a person using the Promote Person to User action on an existing Person record. This action creates a User object record, automatically populates the Source Person field on that User record, and populates the User object reference field on the Person record.

Using the Promote Person to User action rather than creating a new user directly prevents Vault from creating duplicate Person records. You must configure the action on an Active lifecycle state of the Person (person__sys) object. Once configured, the action will be available on Person records in the appropriate lifecycle state.

Document Field Defaulting on the Contributor’s Organization Field

When configured, Vault can automatically populate the Contributor’s Organization document field when a user creates a document of a given type. To do this, the Organization field must be populated on that user’s User object record. Then, when the user creates a new document, Vault automatically populates the Contributor’s Organization document field with the user’s defined organization. Users can manually update this field from the Doc Info page, if necessary.

Including a document field that references the Organization object allows Sponsors to measure and compare CRO performance. For example, your organization could run a report to monitor timeliness, with a DateDiff function calculating the difference between the Document Date field and the Approval Complete Date field, grouped by CRO.

How to Enable Organization Field Defaulting

To allow Vault to automatically populate the Contributor’s Organization field when a user creates a document, you must first enable the feature. Navigate to Admin > Settings > Application Settings and select the Enable Contributor’s Organization Document Field Defaulting checkbox.

Next, add the shared Contributor’s Organization field (contributors_organization__v) to any document types, subtypes, or classifications for which you want Vault to populate the field. If you want to prevent users from updating this field manually, you can also configure field-level security to set this field to Read-Only.

Note that Vault only populates this field on documents of the correct type for a given user when the Organization field (organization__v) is populated on that User object record. Users must also have Read permission on the Organization object.

Type

Permission

Controls

Security Profile

Users: Manage User Object

Grants the ability to execute the Promote Person to User action