Learn about the basic features and functionality of documents in SiteVault.
Doc Info Page
The Doc Info page is displayed when you open a document from the Documents > eBinder or Documents > Library tabs. The Doc Info page displays a viewable rendition of the document along with any associated document information. Among other actions, you can edit document information and initiate workflows and state changes from this page. See the table below to learn more about the different areas and features of the Doc Info page.
1 |
Navigation |
Use the navigation breadcrumbs to navigate back to the Library. |
2 |
Lifecycle State |
Displays the current state of the document. You can also use this button to change the state of the document. |
3 |
Workflow Actions Menu |
Enables you to quickly start a workflow or make a state change, such as approving or finalizing a document. |
4 |
Most Frequently Use Actions |
Your four most frequently used actions are displayed here. The actions that are displayed depend on the context. SiteVault learns the actions that you use most for a particular document type or record and displays those actions first. |
5 |
All Actions Menu |
Contains all of the other non-workflow actions for a document, for example, Create Draft, Make a Copy, and so on. |
6 |
Lifecycle Stages Chevron Panel |
Lifecycle stages help you understand where a document is in its lifecycle by grouping specific lifecycle states into ordered collections of stages. The lifecycle stages chevron panel provides a visualization of the document’s progress, with each chevron representing a single lifecycle stage. The chevrons are color-coded to indicate the document’s current stage:
- Green indicates a previous stage.
- Blue indicates the active stage.
- Gray indicates an upcoming stage.
The lifecycle stages chevron panel can also give details for incomplete tasks. Select the blue (in-progress) chevron to see a list of up to five open tasks. Tasks are displayed on the task card in the same order as they are displayed in the Active Workflow panel. An exclamation point icon is displayed on the blue chevron if one or more tasks are behind schedule.
|
7 |
Document Viewer Controls |
The document controls in the upper-left of the viewer contain the following options:
- View Annotations
- Open Bookmarks
- Open Destinations
- Find in Document
|
8 |
Document View Controls |
The document controls in the upper-right of the viewer contain the following options:
- Rotate Clockwise
- Zoom Out
- Zoom In
- Full Screen
- View Options Menu (including Document, Notes, and Thumbnail views)
|
9 |
Document Information |
Displays document information such as type, study, file information, and version history. |
10 |
Relationships |
Displays document relationships such as any linked or supporting documents. |
11 |
Document Files |
Displays the source file and viewable renditions. |
12 |
Sharing Settings |
Displays what users have access to the document and the permissions granted through the user’s role. |
13 |
Timeline View |
Displays a timeline view of the document’s state changes and workflows. |
Document Version Stacking
If you need to update or replace a document that already exists in SiteVault, the best practice is to stack a new version of the document on top of the existing document (instead of creating a new document). You can do this by creating a new draft, uploading a new version, or checking out the document.
SiteVault stacks the new version on the original document as a new Draft version. The version number is incremented by 0.1. For example, if the current document is version 1.0, the new draft is version 1.1. Then, when you move the document to its steady state, the new steady-state version is the next whole number, for example, 2.0.
Document Lifecycles
Document lifecycles are the sequences of states such as Draft and In Sponsor Review that a document goes through during its life.
SiteVault automatically assigns each document that you create to a lifecycle. From there, the document moves through its lifecycle states based on the actions you take on the document. Some actions are not available in certain lifecycle states, for example, you cannot approve a document if it’s already in a steady state such as Approved for Use.
Select here for information on supported document types and their required fields, naming format, and eBinder locations. See the table below for the states that documents can go through for each lifecycle.
|
Lifecycle
|
Lifecycle States
|
|
Draft to Approved for Use
|
|
|
Draft to Current
|
|
|
Draft to Final
|
|
|
Draft to Finalized
|
|
|
Draft to Fully Executed
|
|
|
Organization Profile
|
|
|
Person Profile
|
|
Document Groups and Lifecycles
- Profile Documents: Apply to people or partner organizations and can exist in the context of your research organization, site, or study.
- At creation, 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.
- Organization Profile documents follow the Organization Profile lifecycle.
- Person Profile documents follow the Person Profile lifecycle.
- Source Documents: For information on Source documents, see Managing Source Documents.
- Financial Documents: Follow the Draft to Finalized lifecycle.
- Legal Documents: Follow the Draft to Fully Executed lifecycle.
- Study Documents: Documents that are specific to your study, such as a 1572. Study documents follow the Draft to Approved for Use, Draft to Current, and Draft to Final document lifecycles (determined by type of document).
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.