Learn how to build your eBinder and upload and manage documents

About Document Workflows and State Changes

Workflows and state changes are used to update document statuses, certify documents as copies, or obtain electronic signatures on documents. Any workflow tasks that are assigned to you are displayed in the My Tasks view in the Home tab. Completing a workflow task can require you to take action such as providing an eSignature, accepting a Connected Study Invitation, or verifying that you’ve read and understood a document.

You can move a document from one state to another by sending it through a workflow or by applying a state change action. These actions can occur from the Document Library or the Study eBinder.

  • SiteVault Document State Changes:
    • Change Status to (final state): Progress the document to its steady state. This state change includes the option to perform Copy Certification.
    • Change State to Internal Review: Indicate that the document is in internal review.
    • Change State to In Sponsor Review: Indicate that the document is in sponsor review.
  • SiteVault Document Workflows:
    • Certify as Copy: Certify the document as a copy.
    • Delete Annotations: Remove any SiteVault annotations from a document.
    • Send for eSignature Approval: Send one or many documents to multiple signatories to approve a record (not PI oversight).
    • Send for PI eSignature: Send the document to your study’s principal investigator (PI) for eSignature. See the Document Types Reference Spreadsheet for information on the documents that can be sent for PI eSignature.
    • Send for Read and Understood: Send one or more study documents to study team members. Each recipient must confirm they have read and understood each study document.
    • Send for Review: Send one or many documents to colleagues who can provide feedback using the annotation tool.

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.

For more information on eSignatures, see Using eSignatures.