Note Only SiteVault users with the Site Administrator system role can complete the tasks on this page.
On a connected study, the sponsor or contract research organization (CRO) can distribute safety documents such as IND Safety Reports or Dear Investigator Letters directly to your SiteVault. You will receive a notification to either confirm the receipt of the safety documents or, if enabled for your site, the safety documents were automatically acknowledged as received. If more than one document is distributed to your site from a given sponsor or CRO, the documents are grouped into a daily digest envelope specific to that sponsor or CRO.
Confirming the Receipt of Safety Documents
Complete the following steps to confirm the receipt of safety documents:
- From either your All Tasks or Notifications view, select Continue on the Please Acknowledge Safety Documents task.
- Review the document or documents and associated information (such as product and study) as needed, select Accept then select Complete.
- Select the Acknowledged option in the Please Acknowledge Safety Documents dialog box, then select Complete. The sponsor is notified that you acknowledged the documents.
Enabling Auto-Confirmation of Safety Documents
Note Although safety documents are automatically acknowledged as received, you must still finalize the documents to file them to your investigator site file.
If the auto-confirmation functionality is enabled, safety documents (of document type Expedited Safety Report) are displayed in your Library in the Received from Sponsor/CRO status.
Complete the following steps to enable the auto-confirmation of safety documents:
- Navigate to Profiles > Sites, and select the site in the Name column.
- Select Edit, select the Auto-Confirm Receipt of Safety Documents check box in the Site Settings section, then select Save.