Managing Profile Documents

Learn how to manage organization and person profile documents for your site or research organization.


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Overview

Profile documents in SiteVault apply to people or partner organizations and can exist in the context of your research organization, site, or study.

When you create the document, you associate the document with the person or organization, and SiteVault makes the document available in the appropriate context. For example, you can upload a CV for a study team member at your site, and SiteVault makes the same document available for all sites in the research organization to which the user has access so that you don’t need to upload the same document for each site. Moreover, SiteVault automatically associates the document to any study to which the study team member or organization is actively assigned.

Profile documents for people and organizations use the Person Profile and Organization Profile document lifecycles, respectively. See the Document Types Reference Spreadsheet for more information on the available document types on these lifecycles.

Before you can get started creating profile documents, a SiteVault user with appropriate permissions must create profile records for the users or organizations. See the Managing Users and Managing Organizations pages for more information.

For general information on working with documents in SiteVault, see the Basics of Managing Documents page.

Creating Profile 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.

Making Profile Documents Current

Note Site Staff users without the Site Profiles add-on permission can create profile documents for their assigned studies but are not able to change the state of the document.

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.

Organization Profile Lifecycle

The following workflows are available to make an organization profile document Current:

  • 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.

Person Profile Lifecycle

The following workflows are available to make a person profile document Current:

  • Certify as Copy: Select this action to start a workflow to certify the document as a copy.
  • Send for eSignature: For CVs only, select this action to send the document to yourself or another site staff member for electronic signature.

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

When you create a new version of a profile document, SiteVault automatically files the document to the same contexts of the original document, including to studies where the user or organization are actively assigned. 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 Study Documents
Managing Legal & Financial Documents