With Veeva Site Connect, you can send documents and document requests to any study site’s SiteVault that has an active Agreement. You can send individual documents and document requests to a target Vault from the Library and Expected Documents, or send Site Packages to multiple sites at once using a single bulk action.
Vault creates Distribution Tasks to track the contents, status, and destination of each document version transferred via Veeva Site Connect.
Note: This feature is only available on Clinical Operations Vaults with Veeva Site Connect enabled. Some configuration is required by an Admin in order to send documents and document requests to SiteVaults.
You can send documents to target Vaults directly from your Library or Expected Documents via user actions. When sending documents, Vault prompts you for different entries depending on the level of the document or document request. Vault determines if a document is site-, country-, or study-level based on the following criteria:
- Site-level: A single value in the Study Site document field.
- Country-level: One or more countries in the Study Country field and no value in the Study Site field.
- Study-level: One or more values in the Study field and no value in the Study Country field or Study Site field.
You can view the following information about if/when each document version has been sent to one or more sites in the document information panel:
- Sent to Site(s): Yes or No; whether the document version has been sent to at least one site.
- Initial Sent to Site(s) Date: The first date that the document version was sent to a site.
- Last Sent to Site(s) Date: The most recent date that the document version was sent to a site.
- Received from Site(s) Date: The first date that the document version was received from a site.
To send documents in your Library to the target Vault:
- Select the Send Document to Sites option from the document’s Actions menu.
- For site-level documents, select an Action and Due Date. For study and country-level documents, select the Study Sites that will receive the document. Only sites with active Agreements for the document’s Study or Study Country are available to select.
- Optional: Enter Comments.
- Click Send. You will receive a notification when document distribution is complete.
To send matched Expected Documents to the target Vault:
- Navigate to Planning > Expected Documents and select the Expected Document.
- From the Actions menu, select the option to send matched documents. If the record contains matched documents, Vault will send a site-specific version of the document to the target Vault. If the record does not contain any matched documents, Vault will send a request to the target Vault to provide the document.
- For site-level documents, select an Action and Due Date. For study and country-level documents, select the Study Sites that will receive the document.
- Click Send.
Recalling a Document
To recall a document:
- Navigate to the document you want to recall in the Library.
- From the Actions menu, select Mark Recalled.
- Select the Study Site(s) from which you want to recall the document.
- Click Continue.
- Click Yes.
After you recall a document, the value of the Recalled by Sponsor/CRO field in the SiteVault-side document information panel becomes Yes.
With Site Packages, you can send multiple documents and document requests to one or more Study Sites with active Agreements for a Study Country.
The pre-configured Site Package Definition that you select for a Site Package determines which template of documents your Vault will exchange with a SiteVault.
Select the option to send Site Packages from the Actions menu of an active Study Country or Study Site record.
After selecting a Site Package Definition and Due Date, Vault displays a list of Study Sites with active Agreements associated with the Study Country. Select the Study Sites that will receive a package and click Next to preview the Site Packages.
Vault displays each Site Package for individual sites. Click on a package to view the documents and document requests included in that Site Package. To modify the contents of a Site Package, click + Add to include additional documents and document requests or hover over an item and click the X icon to remove it from the package.
Click into the Comments column to enter any relevant comments for individual documents. Depending on the Site Package Definition you selected for the Site Package, you may see default values in the Comments fields that an Admin has configured.
Vault displays a red exclamation icon () if an issue prevents Vault from sending a document or document request to the site. Hover over the icon to see the issue details. For example, Vault only sends documents in states that have been configured for the Send Documents to Sites user action and will indicate if one of the documents in the Site Package is not in the correct state.
After making adjustments and resolving any outstanding issues, click Next to confirm the Site Packages. Vault will remove documents with unresolved issues from the Site Package.
Review the Site Packages that Vault will send to each Study Site. The summary includes an overview of how many items Vault will send to each Study Site. Click Send to send the Site Packages to the target Vaults.
Received from SiteVault Notifications
After any requested documents have been created in the Clinical Operations Vault from a specific Study Site, the requesting user receives a summary notification alerting them of the documents created. The frequency of these notifications varies based on Admin configuration.