You can upload documents to a connected Sponsor or CRO’s Clinical Operations Vault. Vault supports sending multiple documents at once. You can upload files from your local computer or directly from SiteVault if you have connected it for the Study. Once you have uploaded a document, the document action no longer appears in the Document Actions list. The Upload Additional Documents tool allows you to send up to 100 documents. You can only send certain document types to a Sponsor or CRO Vault.
Uploading restricted (unblinded) documents may require additional permissions; see the Restricted Permissions section below for more information.
To send a document:
- In the Document Exchange > Document Actions tab, locate the document you wish to send in the Document Actions grid.
- Click Upload.
- Select the Upload Method. There are two options: Upload and SiteVault Documents.
- If uploading, select the document, enter a Description, enter Comments, and click Upload. Click Continue to complete the process.
- If uploading SiteVault documents, select the document name to review, select the updated document, enter Comments, and click Upload.
- Click Continue to complete the process.
Restricted Permissions in Site Connect and SiteVault
Site Connect and SiteVault permissions are managed by different systems and administrators; a user’s access to restricted documents in one system does not guarantee the same access is assigned in the other. See the table below for the expected behavior based on different permission combinations.
Restricted Permissions | Site Connect Behavior | SiteVault Behavior |
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No Restricted Access |
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Restricted Access in Both |
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Restricted Access in Site Connect No Restricted Access in SiteVault |
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No Restricted Access in Site Connect Restricted Access in SiteVault |
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