Document Exchange Description
Document Exchange provides a user-friendly space to easily exchange study-related documents between a sponsor or CRO’s Clinical Vault and a SiteVault, without the use of an eRegulatory application.
SiteVault Use
Using Document Exchange, site staff can perform the following actions:
- Send documents to a sponsor or CRO
- Respond to document requests from sponsor or CRO
- Receive documents from sponsor or CRO
Sponsor Use in Clinical Vault
Using Site Connect for Document Exchange, sponsors or CRO study teams can perform the following actions:
- Send documents to sites
- Send documents requiring an action to sites
- Request documents from sites
- Request a group of documents from sites (package)
- Recall a document that was sent in error
- Receive documents from sites
Receiving and Sending Documents
Receiving Documents
- Upon receipt of a document in Study Connect, a Draft copy is stored in SiteVault eRegulatory, even if SiteVault eRegulatory is not in use.
- Only certain document types can be received from a sponsor or CRO’s vault.
Sending Documents
- Delivers documents to a connected sponsor or CRO’s Clinical vault.
- Can send multiple documents at a time.
- SiteVault eRegulatory users have the ability to send documents filed in the Study eBinder.
- Once completed, document action is removed from Document Actions list.
- Send Additional Documents tool can send up to 100 documents, uploaded or from SiteVault eRegulatory.
- Only certain document types can be sent to a sponsor or CRO’s vaults. For more details, see Document Types.
Send Failures
- Send failures occurring before actual send attempt will trigger a dialog, advising user to try again.
- Send failures occurring during send process will trigger an email to the site with a consolidated list (by study) of all send failures.
- Send failures are displayed as a notification in SiteVault eRegulatory.
- Send failures are not displayed in Documents > Sent.
Sending a Document Multiple Times
- When a user attempts to send a document that was already sent, the user receives a warning that the document was already sent.
- Study Connect will not prevent a user from sending a document multiple times.
Versioning Between Vaults
- Each vault maintains document versioning independently.
- If a received document does not already exist in the receiving vault, it is created as version 0.1.
- If a received document already exists in the receiving vault, it remains at the same version if there is no change to content.
Notifications
SiteVault User Notifications
SiteVault users with study access receive notifications when the following actions occur:
- Documents are received from a sponsor or CRO’s vault
- Document requests are received from a sponsor or CRO’s vault
Sponsor or CRO Vault User Notifications
Sponsor or CRO vaults receive notifications when the following actions occur:
- Documents have been received from a SiteVault
- Document request is rejected