Veeva Site Connect is an add-on product available on Clinical Operations Vaults. It seamlessly connects and automates the sharing of data between Clinical Operations Vaults used by sponsors and CROs, and SiteVault Vaults used by study sites. With Veeva Site Connect, you can quickly exchange documents, document requests, and data with research sites on SiteVault. You can also email safety reports to any research site, even if they don’t use SiteVault.
Contact Veeva Support to add Veeva Site Connect to your Clinical Operations Vault.
Veeva Site Connect Features
- Agreements: Create study-specific Agreements to initiate the transfer of data, documents, and document requests between your Vault and a site’s SiteVault.
- Version-Specific Document Transfer: Document versioning is maintained by each Vault independently.
- Send Documents and Document Requests: Send documents and document requests to target Vaults directly from the Library and Expected Document records.
- Site Packages: Send multiple documents and document requests to multiple study sites.
- Document Reconciliation: Reconcile documents between your Vault and a site’s eISF in their SiteVault to ensure that the correct versions of all relevant Steady state documents exist in both Vaults.
- Comments on Document Exchange: Send and receive comments when exchanging documents and document requests with SiteVault.
- Safety Distributions: Send safety reports to all sites, including sites that aren’t on SiteVault.
- Automatic Classification of Profile Documents: Receive classified profile documents from SiteVault. Vault automatically classifies transferred profile documents based on the document’s classification in the source SiteVault and the configuration of the Vault Clinical Docs reference model in your Vault.
- Payment Letters and Site Invoices: Send payment letters and site invoices directly to sites on SiteVault Vaults.
Veeva Site Connect utilizes multiple objects to house relevant data. This is a list of core related objects, but it does not include all objects.
- Agreement: A study-specific record of an agreement between a Clinical Operations Vault and a SiteVault Vault that allows data exchange to occur.
- Clinical Network Rule Set: A set of rules that determines data transfer logic between two Vaults. Veeva defines and provides these rule sets for you.
- Organization: A specific research site institution, including the USN assigned to each clinical research site.
- Study Site: A research site where you are conducting a clinical trial or study.
- Site Package Definition: A set of Site Package Documents that you can send in bulk to multiple study sites.
- Site Package Document: A specific document type included in a Site Package Definition that Vault sends to study sites as part of a Site Package.
- Distribution Task: A task that tracks the contents, status, and destination of documents and document requests sent via Veeva Site Connect.
- Safety Distribution: A safety document and supporting Safety Distribution Support documents.
- Site Document Check: A site-specific set of Document Check records that details document comparison between your Vault and a site’s SiteVault.
Study Site Agreements
Before you can exchange study-specific data, documents, and document requests with a SiteVault, you must first set up a study-specific Agreement with that site. When the Agreement is approved and activated in SiteVault, Vault creates relevant study-related records in the target Vault. You can then transfer documents, send document requests, and receive documents.
Receiving Documents from Sites
When study sites send documents from SiteVault, Vault includes any relevant comments for individual documents and document requests in the related Distribution Task you receive in your Clinical Operations Vault.
Receiving Profile Documents
Vault automatically classifies profile documents received from SiteVault Vaults based on the document’s classification in the source SiteVault and the configuration of the Vault Clinical Docs reference model in your Vault.
Learn about using Veeva Site Connect in these articles:
- Document Transfer Behavior
- Setting Up Study Site Agreements
- Sending Documents & Document Requests
- Distributing Safety Documents
- Document Reconciliation
Learn about configuring Veeva Site Connect in these articles: