Creating and Finalizing Documents
SiteVault offers you several ways to upload and finalize all of the documents you need for your site or research organization. But the best way to manage documents depends on the document type.
See the following pages for more information on creating and managing documents depending on the document type:
- Managing Source Documents
- Managing Study Documents
- Managing Profile Documents
- Managing Legal & Financial Documents
Editing Document Fields
If you need to edit information (a field) on a document, navigate to and open the document and select Edit Fields on the Document Information panel.
Note that the system populates some fields automatically based on the document type and not all fields are editable. Moreover, if the Edit Fields button isn’t displayed, your system role doesn’t have permission to edit the document or to edit the document in a particular state. See the SiteVault Permissions Visual Map for more information.
Creating New Draft Versions
If you need to update an existing steady-state or major version document (such as adding a newer version of a site staff member’s CV), you can create a draft of the document to start a new drafting cycle.
Complete the following steps to create a new draft version of a document:
- Navigate to and open the document, and select Create Draft from the All Actions menu.
- Upload the new version’s source file, or copy and reuse the current source file.
- Optionally, enter a description of the new version. Other users can view this description in the document’s version history.
- Select OK. SiteVault stacks a new version of the document on the original document.
Checking Out Documents
For nonsteady-state documents, you can check out a document to download the document to your computer, edit as needed, and reupload to SiteVault. Complete the following steps to check out a document:
- Navigate to and open the document, and select Check Out from the document’s All Actions menu. The document is downloaded to your computer and a lock icon () is displayed on the Doc Info page of the document to indicate that it’s checked out.
- Open the downloaded document and edit as needed.
- When finished, select Check In from the document’s All Actions menu, upload the document using the dialog box, then select Check In. SiteVault stacks the updated document on the original document.
If needed, you can select Undo Checkout from the document’s All Actions menu to cancel the checkout without updating the document.
Uploading New Document Versions
For nonsteady-state documents, you can upload a new version of the document if needed. Complete the following steps to upload a new version:
- Navigate to and open the document, and select Upload New Version from the document’s All Actions menu.
- Use the dialog box to select the new version to be uploaded. Optionally, enter a description of the new version. Other users can view this description in the document’s version history.
- Select OK. SiteVault stacks the new version on the original document.
Making a Copy of a Document
You can reuse documents in SiteVault by using the Make a Copy action. This can be useful if you need to make a copy of an approved template to check out and complete and reupload to SiteVault. Complete the following steps to copy a document:
- Navigate to and open the document, then select Make a Copy from the document’s All Actions menu.
- Select whether to copy the document’s content or fields or both, then select Continue. Note that although you can enter a name for the document in the dialog box, SiteVault automatically names the document based on the document type.
- Optionally, update the document fields in the General section as needed.
- Select Save. The document is copied as a new 0.1 version of the original document.
Working With Document Templates
For any documents that are copied from another document, you can keep the document in sync with the original document using the Create Draft from Original Document action. This makes it easy to manage and track document templates such as an Informed Consent Form (blank) or Financial Disclosure Form and their subsequent copies.
To create a new draft of a document based on its original document, select Create Draft from Original Document from the document’s All Actions menu.
To view the original document that a copied document is based on, expand the Relationships panel on the Doc Info page of the document.
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.
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:
- Navigate to and open the document that requires your signature. You can access it by selecting the link in the email or from the My Tasks view in the Home tab of SiteVault.
- Select Complete on the task.
- Enter required and any optional information in the dialog box, then 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 [Number] 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 tab of the browser window.
Site Staff users can delete versions of documents that they created as long as the document is still in the Draft state (a document version such as 0.1 or 1.1). Research Organization Administrator and Site Administrator users can delete any draft document, regardless of who created it.
Complete one of the following actions to delete a draft document:
- Documents that have never had a major version (for example, version 0.1): Select Delete from the All Actions menu of the document that you want to delete, then select Delete in the dialog box. This action also deletes all versions (if they exist) of the document. If you only need to delete a specific version of the document, expand the Version History section of the document’s Information panel, and select Delete from the actions menu for that version.
- Documents that have a major version (for example, version 1.1): Expand the Version History section of the document’s Information panel, select Delete from the actions menu for that version, then select Delete in the dialog box. This action removes the specific version but leaves all other versions of the document.
Research Organization Administrator and Site Administrator users can delete steady-state documents. See Deleting Steady-State Documents for more information.
To change the state of a document to Superseded, navigate to and open the document and select Change State to Superseded from the document’s Workflow Actions menu. The action is only available on the current major version of a document. If the action is not displayed or is displayed but unavailable, your current system role doesn’t include permissions to supersede a document.
In rare circumstances, SiteVault may not successfully generate a viewable rendition of your document. Re-rendering the document may solve issues that you’re having and replaces the currently viewable rendition of the document version with a new rendition.
Complete the following steps to re-render a document:
- From the document’s All Actions menu, select Re-render Document.
- If applicable, select an option or options in the dialog box, then select OK.
During a document’s complete lifecycle, it can undergo many changes. SiteVault enables you to compare two versions of a document to see what has changed between them. Note that you must have the permissions to view the content and document on both versions.
If a document has more than one version, the Version History section is displayed in the Information panel of the document. To compare the current version with a past version, expand the Version History section and select Compare Versions from the ellipses menu (…) of the version that you want to compare.
When you compare two versions, SiteVault opens the document in comparison mode. Inserted text is highlighted in purple and deleted text is marked with a note. Select the Back to previous page link to close comparison mode.
Note that some limitations apply to comparison mode. For example, SiteVault only detects changes to the text and not images, formatting, page additions or removals, or other structural changes.
You can use the cart to quickly create an ad hoc group of documents from multiple filter sets and library views. From your cart, you can download source files or viewable renditions in bulk.
Your cart serves a different purpose than Favorites, which are more useful for storing a list of documents that you reference frequently. Like Favorites, your cart is specific to you. No other user can see your cart.
If there are documents in your cart that you can no longer view, SiteVault displays a warning and automatically removes them when you next access your cart.
To access your cart, select View Cart on the primary navigation bar. The number that is displayed above the button indicates the number of documents currently in your cart. If more than 99 documents are in your cart, 99+ is displayed.
Adding or Removing Documents
To add a document to your cart, select Add to Cart on the header of a document or on the row of a document in the library.
A green plus (+) symbol on the button indicates that you can add the document to your cart. If the button is unavailable, your cart contains the maximum number of documents allowed.
A red minus (–) symbol on the button indicates that the document is already in your cart. Selecting removes the document. Select Remove from Cart to remove the document.