Veeva Site Connect is an add-on product available on Clinical Operations Vaults. It seamlessly connects and automates the sharing of data between sponsors/CROs and clinical research sites. With Veeva Site Connect, you can quickly exchange documents, send document requests, and share data with research sites through the site’s home page on your Clinical Operations Vault. You can also email safety reports to any research site, even if they do not log into the system.
Contact Veeva Support to add Veeva Site Connect to your Clinical Operations Vault.
Note: Sponsor and CRO users can view and download an information sheet with additional details on Veeva Site Connect.
Veeva Site Connect Features
- Send Documents and Document Requests: Send documents and document requests to target Vaults directly from the Library and Expected Document records.
- Send Site Packages: Send multiple documents and document requests to multiple study sites at the same time.
- Document Reconciliation: Reconcile documents between your Vault and a site’s eISF in SiteVault to ensure that the correct versions of all relevant Steady state documents exist in both Vaults.
- System Links: Share a list of systems used throughout the course of the Study, including links to those systems.
- Study Contacts: View a list of names, roles, contact information, and comments for Sponsor and CRO study personnel.
- Study Site Addresses: Create and manage study-specific addresses for a site and receive addresses entered by the site in Site Home.
- Study Announcements: Post study announcements, such as news and trial deadlines, in Site Connect. These posts are visible to site users and sent to Sites as email notifications.
- Safety Distributions: Send safety reports to all sites.
- Payment Information: Send payment information directly to sites.
Related Objects
Veeva Site Connect utilizes multiple objects to house relevant data. This is a list of essential, related objects, but it does not include all objects.
- 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.
- Distribution Task Recipient: A record that tracks the email, recipient, and status of Distribution Tasks sent to individual study site personnel
- 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 Person: The site user invited to exchange study-specific data, documents, and document requests.
- Study Site Address: A study site specific address utilized for a specific purpose.
Study Site Users
Before a site user can exchange study-specific data, documents, and document requests, they must have access to Site Connect. To do this, enable the Site Connect User field on their Study Person record. Once enabled, the user will receive an invitation email with a link to log in to Site Connect. Once logged in through their VeevaID account, they can begin completing document actions and receiving documents. In addition, they can connect their site to SiteVault if they have a valid USN, a unique identifier assigned by Veeva to each clinical research site that uses SiteVault.
Note: While we recommend study site personnel access Site Connect via their Veeva ID, Site Connect does not require it to receive Document Exchange or Safety Distribution documents.
Using Study Person Responsibilities in Site Connect
Study Person Responsibilities grant users access and notifications for various Site Connect capabilities. When managing Study Person Responsibility records, you can enter Start and End Dates to indicate the time period that Study Person should have that Responsibility. Site Connect only allows users access to features and notifications managed by Responsibilities between the Start and End Dates on the Study Person Responsibility records.
| Site Connect Capability | Responsibility | Purpose |
|---|---|---|
| Safety Distribution | Assess Safety Distribution (Primary) | Allows users to acknowledge the receipt of safety documents by viewing the documents and receive Safety Distribution notifications. |
| Safety Distribution | Assess Safety Distribution (Secondary) | Allows users to manually acknowledge the receipt of safety documents in Site Connect and receive Safety Distribution notifications. |
| Document Exchange | Maintain Essential Documents | Allows users to receive Document Exchange notifications. |
| Unblinded Documents in Document Exchange | Manage Unblinded Content | Allows users to access unblinded (restricted) content and receive Document Exchange notifications for unblinded (restricted) content. |
| Payment Information | Manage Site Reimbursements | Allows users to access the Payment Information tab in Site Connect. |
Updating Email Address in VeevaID
Site users can update their email address in VeevaID. When users update their email address, Site Connect updates all corresponding records. This ensures site users retain access to their assigned studies.
Ending Study Person Access to Site Connect
Enter an End Date on a Study Person record to indicate when a site staff’s participation in a given Study ended. When the system reaches the End Date for a Study Person record with the Site Connect User field enabled, the Revoke Access from Study Persons with End Date job unchecks the Site Connect User field. This removes the study site person’s access to Site Connect, including Site Connect-related notifications.
Receiving Documents from Sites
When study sites upload documents in Site Connect, 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.
Related Articles
Learn about using Veeva Site Connect in these articles:
- Document Transfer Behavior
- Sending Documents & Document Requests
- Distributing Safety Documents
- Document Reconciliation
Admin Articles
Learn about configuring Veeva Site Connect in these articles: