User Types in SiteVault

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Navigate to the Profiles > Users tab and find your user record. Check the value in your User Type field, then skip to the appropriate section below.

Regulatory users can create and edit users, studies, organizations, and study products. They can also manage study assignments (assigning staff members, products, partners, and external users to studies).

Study Team type users, on the other hand, can view users, studies, organizations, study products, and study team assignments in SiteVault Free, but they are not able to create or edit them. They are also only able to see the studies they have been given access to through Study Team assignments.

External users only have access to the Home, Documents > eBinder, Documents > Library, Reporting > Reports, Reporting > Dashboards, and Help tabs. They are only able to view and download the final, inspection-ready versions of documents for studies that they have been given access to through the Monitor & Auditor Assignments section on studies. They cannot create or manage users, studies, organizations, study products, study assignments, or any other types of data within SiteVault Free. They also cannot create or edit documents in SiteVault Free.

User Type Can see? Create records (user, person, org, product, study) Profile Documents (CV, License, IRB roster, Labs) Financial Documents (Contract, budget, etc) Study Documents Workflows? Reports
Regulatory All Studies (at Site) Create, Edit, DeleteCreate, Edit, Delete Create, Edit, Delete Create, Edit, Delete Yes Read All
Study Team Studies as Assigned View onlyView only - all at Site View only -assigned studies Create, Edit, Delete (Drafts only) for Assigned Studies Yes Read All
External (Sponsor, CRO, Auditor) Studies as Assigned View only (through document metadata) View only - Major Versions on Assigned Studies No access View only - Major Versions on Assigned Studies No Read, only certain reports

Watch Getting Started videos here.

Regulatory User

The best way to get started is to add more site staff into SiteVault. Each user that you add will receive a Welcome to SiteVault email, and their own SiteVault user account. Once you have at least one user in SiteVault, the next thing you can do is create profile documents (CV, Medical License, Training Evidence) for that user. Once you have created a CV for a user, you can send it to them for eSignature and see the document move from Draft to Current, version 1.0.

Next, create some Organization records for the Sponsors, CROs, and IRBs that your site is working with on studies. You’ll use these in the next step when you create your first study.

Now that you have some users and organizations, you’re ready to create a study. Under a created study, you will find sections where you can specify the Study Products and Study Partners (CROs, Labs, etc.) for the study. You’ll also find a section where you can assign your site’s users to the study. Assigning them to the study will ensure they can see and create documents for the study. Go ahead and assign one of the users you created earlier to your Study Team.

Continue to the Study Team User section below.

Study Team User

Navigate to the Studies tab, and select the All Studies view on the left of the page. If you don’t see any studies, ask a Regulatory user at your site to assign you to one.

Get started by creating a study document. Once the document fields have been entered, use the Actions menu to update the document’s state (or, if the file you used is a scan of a paper document, run the certified copy workflow on the document). You should see the document’s version go from 0.1 to 1.0 - this is now a major version (inspectable) document for the study.

Major version documents sometimes get revised over the course of the study. If you have a document that is already a major version but needs to be revised, create a new draft version of the document.

Continue to the External User section below.

External User

All inspectable documents for a study are displayed in the Study eBinder. Navigate to the eBinder, select a study, and review its documents. When you want to look at work-in-progress documents, or view documents across several studies at once, you can use the Library’s powerful filtering and search capabilities.

SiteVault provides dashboards & reports to help you track important information about your study documents. Once you and your colleagues have created a few documents, explore the dashboards & reports.

Patients & Participants