Organizations often reuse Person-, Organization-, and Product-related documents, such as CVs and Lab Certifications, across many studies. Manually updating this field for each new document version, or each time a new Person, Organization, or Product is associated with the study, is a time-consuming process.
With document reuse functionality, Vault can automatically populate and maintain the Study, Study Site, and Study Country fields on defined document types as Persons, Organizations, or Products are added to and removed from studies. This prevents users from needing to manually maintain which document versions are applicable for which studies. Vault also automatically updates the Product field based on the values in the Study, Study Site, and Study Country fields.
Components for Document Reuse Across Studies
Clinical Operations Vaults include the following components to support document reuse:
- Person Profile, Organization Profile, and Product Profile Document Type Groups: These pre-configured Document Type Groups identify the Person-, Organization-, and Product-specific document types that are often reused across studies. Vault can automatically update the Study, Study Site, and Study Country fields for document types that belong to one of these Document Type Groups when a user adds or removes Persons, Organizations, or Products from studies.
- Study Person, Study Organization, and Study Product objects: Users must create Study Person, Study Organization, and Study Product object records for Vault to automatically update the Study, Study Site, and Study Country fields on related document versions.
- Refresh Study Values on Associated Documents user action: This action updates values on all related document versions. When configured, users can select this action on any Study Person, Study Organization, or Study Product record.
- Delete and Cleanse Associated Documents user action: This action deletes the record and removes the study from any document versions with which it is currently associated. Note that deleting a record using the standard Delete option does not remove the study on associated documents. When configured, users can select this action on any Study Person, Study Organization, or Study Product record.
Admin: Adding to Document Type Groups
Admins must add any document types to the pre-configured Document Type Groups to enhance content reuse functionality and scope within your Vault.
Admin: Configuring User Actions
Admins may configure the Refresh Study Values on Associated Documents and the Delete and Cleanse Associated Documents user actions on active object lifecycle states for the Study Person, Study Organization, and Study Product objects.
Admin: Configuration Limitations
The following limitations affect content reuse configuration:
- The Study, Study Site, and Study Country fields will appear on documents in the designated Document Type Groups regardless of any configured Field Level Security settings.
- Admins cannot edit or delete the configured Document Type Group records, or make them inactive.
- Admins cannot assign a document type to more than one Document Type Group.
How Vault Populates the Study Field
Using pre-configured Document Type Groups, Vault automatically updates the Study, Study Country, and Study Site document fields based on the Person, Organization, or Product records associated with a Study.
When a user uploads, classifies, or reclassifies a document belonging to one of the configured Document Type Groups, Vault automatically populates the Study, Study Site, and Study Country fields based on the studies associated with the Person, Product, or Organization populated on the document. Vault updates Study values to add new studies or remove irrelevant studies on the latest version of all related documents each time a user creates, deletes, or inactivates a Study Person, Study Organization, or Study Product record.
When a document is versioned, Vault removes Study values from the new version for any Study Person, Study Organization, or Study Product that is no longer active for that study.
How Vault Populates the Product Field
Vault automatically defaults the Product field based on the Lead Agent products associated with the study values in the Study field. It then updates the Product field any time the Study, Study Site, or Study Country fields on the document are modified.
Vault does not default the Product field on documents classified into profile-related Document Type Groups.
About Document Classification
The following behaviors dictate how Vault updates Study, Study Site, and Study Country field values when a user classifies or reclassifies a document in a defined Document Type Group:
- When a user classifies or reclassifies a document into a document type that is assigned to a defined Document Type Group, Vault automatically updates the Study, Study Site, and Study Country fields.
- When a user initially classifies a document into a document type that is assigned to a defined Document Type Group, Vault automatically populates the Study, Study Site, and Study Country fields before a user saves changes.
- When a user reclassifies a document into a document type that is assigned to a defined Document Type Group, Vault populates the Study, Study Site, and Study Country fields after the user saves her changes.
Content Reuse Limitations
The following limitations affect content reuse functionality:
- Users cannot manually update the Study, Study Country, or Study Site fields on Person-, Organization-, or Product-specific documents; these fields become read-only.
- Vault doesn’t update the Study field when the document is archived.
- Vault does not apply document reuse functionality to documents transferred from a SiteVault Vault via Veeva Site Connect or from a RIM Submissions Vault via the Clinical Operations & RIM Vault Connection. All updates to those documents are limited to updates received from the source Vault.