Managing Study Documents

Learn how to create and manage study documents in SiteVault.


Overview

This page is about creating and managing documents that are specific to your study such as a 1572. Study documents in SiteVault follow the Draft to Approved for Use, Draft to Current, and Draft to Final document lifecycles. See the Document Types Reference Spreadsheet for more information on the document types that are available on these lifecycles.

For more information on managing other regulatory documents such as legal or financial documents or profile documents, see the following pages:

See the Basics of Managing Documents page for general information on working with documents in SiteVault.

Creating Study Documents

Note The steps in this section are for creating new documents. If you are adding an updated version of a document that already exists in SiteVault, upversion the document instead. If you want to create documents in bulk, see the Creating Documents in Bulk section below.

Complete the following steps to create documents:

  1. Navigate to the Documents > Library tab and select Create.
  2. Select Upload in the dialog box, then select Continue. If you want to create a placeholder for a document that you expect to upload later, select Placeholder.
  3. Either drag and drop files into the blue area or select Choose. Uploading multiple files creates multiple documents.
  4. Select Classify documents now, search for and select the document type, then select Next.
  5. Complete required and any additional fields as needed, then select Save.

SiteVault creates the document in a Draft status. Ensure that you move the document to its steady-state using the steps in the section below.

Moving Study Documents to the Steady State

Moving documents to their steady state ensures that the documents file appropriately to your study eBinder and 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). See the sections below for more information on moving documents to their steady state depending on their lifecycle.

To start the workflow, select the appropriate action from the document’s Workflow Actions menu.

Draft to Approved for Use Lifecycle

The following workflows are available for study documents on this lifecycle:

  • Certify as Copy: Select this action to start a workflow to certify the document as a copy.
  • Change State to Approved for Use: Select this action to automatically move the document to the Approved for Use state.

Draft to Current Lifecycle

The following workflows are available for study documents on this lifecycle:

  • Certify as Copy: Select this action to start a workflow to certify the document as a copy.
  • Change State to Current: Select this action to automatically move the document to the Current state.
  • Send for PI eSignature: For select documents, select this option to 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.

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.

Draft to Final Lifecycle

The following workflows are available for study documents on this lifecycle:

  • Certify as Copy: Select this action to start a workflow to certify the document as a copy.
  • Change State to Final: Select this action to automatically move the document to the Final state.
  • Send for PI eSignature: For select documents, select this option to 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.

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.

Creating New Draft Versions

Complete the steps in the help for Creating New Draft Versions to update a steady-state document.

Creating Documents in Bulk

Note The steps in this section are for creating new documents. If you are adding an updated version of a document that already exists in SiteVault, upversion the document instead.

You can create documents in bulk using the Document Inbox. Documents created using the document inbox are created in an Incomplete state, which means that they do not yet have an assigned document type. Before being able to move the documents to their steady-state, you must first complete the documents. See the section below for more information.

To upload documents in bulk, navigate to the Documents > Library tab and select the Document Inbox view. Drag and drop the files from your computer directly into your Document Inbox. You can drag and drop up to 250 files at a time. Optionally, apply fields such as Study, Organization, and Person for the documents in bulk using the Bulk Apply Fields dialog.

Note If the Bulk Apply Fields dialog is not displayed when uploading files to the Document Inbox, you can re-enable it by selecting Enable Bulk Update on Upload from the Document Inbox’s Actions menu.

When SiteVault begins to upload files that you’ve dropped into your Document Inbox, you’ll see a dialog in the bottom-right corner that lists the status of all files you are uploading. While SiteVault is uploading your files, you can drag and drop additional files or navigate to other pages in SiteVault while monitoring the progress in the status dialog. Select Navigate to Inbox on the collapsible dialog to navigate back to the Document Inbox from anywhere in SiteVault.

Document Inbox button on collapsible dialog

The color of the arrow icon on the status dialog indicates the status of the upload. Selecting close (X) after all uploads are complete removes the status dialog from your view. If necessary, refresh your browser window to view the uploaded files once the upload is complete. Note that closing your browser, browser tab, or refreshing your page before the file upload is complete cancels all remaining uploads.

Completing Incomplete Documents

Complete the following steps to complete (or classify) one or more documents in the Document Inbox:

  1. Select one or more documents, then select Complete.
  2. Search for and select a document type in the dialog, then select OK.
  3. If you selected just one document, complete required and any additional fields as needed.
  4. If you selected more than one document, select one or more documents using the checkboxes, and enter required and any additional fields as needed in the right panel. Select Apply when you’re finished completing the fields for the selected documents.
  5. Select Save. The document or documents are moved to the document library.

Managing Source Documents for Remote Monitoring
Managing Profile Documents
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