Note The electronic signature in SiteVault is nonbiometric and requires the application of two distinct components (a user ID and password) and is compliant with the Food and Drug Administration's (FDA's) 21 CFR Part 11 section §11.200 requirement of electronic signatures that are not based upon biometrics.
eSignature Overview
eSignatures provide a way for users to complete approval tasks and electronically sign documents. Documents have varying eSignature needs based on the document type and state. SiteVault will only offer an eSignature workflow appropriate for the document type and its current lifecycle state.
There are three eSignature document workflows:
- Send for eSignature Approval
- Collect eSignatures on documents requiring one or more signatures for approval.
- Available on the Draft to Current and Draft to Final lifecycles.
- Available while in the Draft status.
- Not intended for Principal Investigator (PI) oversight.
- Send for eSignature
- Available on document types that require an eSignature for a specific reason (typically noted on the form).
- Available while in the Draft status.
- Examples:
- CV
- Financial Disclosure
- Informed Consent Form (signed)
- Send for PI eSignature
- Send the document to your study’s PI for eSignature.
- Available on document types that require PI eSignature (typically noted on the form).
- Examples:
- 1572 or Equivalent
- Acceptance of IB
- Delegation of Authority
- Protocol Signature Page
eSignature Tasks
To simultaneously send multiple documents for eSignature, see Multi-Document Workflows.
Sending Documents for eSignatures
Complete the following steps to send a document for an eSignature:
- Locate and select the document in the Library or eBinder.
- Select the eSignature workflow from the Workflow Actions menu.
- Select who should sign the document.
- If available, add task instructions. These instructions will appear in the All and My Tasks notifications as well as on the document task ribbon.
- Select a due date.
- Select Start to begin the eSignature workflow.
Note The eSignature workflows can also be initiated from the eBinder Document Menu.
Completing eSignatures
If you or another person at your site sends you a document to sign electronically, you’ll receive a notification in SiteVault and by email to complete the task.
Complete the following steps to complete the task and electronically sign the document:
- Locate and select the document in the Library or eBinder. You can also access it by selecting the link in the notification email or from the My Tasks view in the Home tab of SiteVault.
- Select Complete on the task.
- Enter the required and any optional information in the dialog box.
- Select Complete.
Viewing eSignatures on Documents
You can view an eSignature on a document from the Information panel while viewing a document.
Complete the following steps to view an eSignature:
- Navigate to and open the document.
- If necessary, expand the Information panel.
- In the Signatures section, you’ll see the eSignatures on the document. Additionally, you can select the Signature Page link to view the signature page in a new browser tab.