SiteVault offers you several ways to upload and finalize all of the documents you need for your site or research organization. On this page, you’ll find a brief overview of the tools used to manage document progress and the steps to create and finalize documents.

Document Lifecycles, Workflows, and State Changes

The process of finalizing a document is accomplished by progressing the document from its starting state (Draft or Received from Sponsor/CRO) to its steady state (Current, Final, etc.). SiteVault uses lifecycles, workflows, and state changes to complete this process.

• When you create a new document in SiteVault, the document is assigned a lifecycle based on the document type.
• Documents move through a series of lifecycle states (or statuses) based on the actions you take (workflows, state changes, etc.).
• A workflow can include several steps, while a state change is a direct state-to-state action.
• Documents in the Draft state typically require additional reviews, updates, or approvals.
• Documents in their steady state are considered official study records and available for monitor reviews.
• Documents can be moved to a Superseded state when a newer version of the document has been finalized. This happens automatically when you stack document versions.

Create and Finalize Document Tasks

The information in this section is to provide direction for creating new documents and for moving documents to their steady state. If you are adding an updated version of a document that already exists in SiteVault, upversion the document instead.

Create New Documents from Uploaded Files

You can create documents from the Document Library or the Study eBinder. Documents uploaded to the library are created in the Draft state; documents uploaded to the Study eBinder can move to their steady state as part of the upload process.

• For steps to upload documents to the Study eBinder, see Study eBinder.
  
• For steps to upload documents to the Library, see Document Library.

Move Documents to their Steady (Final) State

Moving documents to their steady state ensures that the documents are available to be viewed by users who only have permissions to view the steady state version of the document (for example, a sponsor, monitor, or study participant).

From the Document Library

1. Locate and select the document in the Library.
2. From the All Actions menu, select Change Status to {XXXX}, where XXXX is the document type’s final status.
3. Complete the Document Date field.
4. Additional Actions
   • If no further actions are required, select Save to complete the process.
   • If copy certification is required, select Perform Copy Certification.
     • Complete the copy certification.
     • Select Save to complete the process.

From the Study eBinder

1. Locate the document in the eBinder.
2. From the Document Actions menu (…), select Change Status to {XXXX}, where XXXX is the document type’s final status.
3. Complete the Document Date field.
4. Additional Actions:
   • If no further actions are required, select Save to complete the process.
   • If copy certification is required, select Perform Copy Certification.
     • Complete the copy certification.
     • Select Save to complete the process.