Setup Steps

Complete the following steps to complete an initial setup of SiteVault:

1. Sign up for SiteVault
   • The site staff member who signed up for SiteVault is assigned the role of Site Administrator.
2. Select an additional System Administrator (suggested)
   • As only Site Administrators can complete certain tasks, we recommend that you designate at least one other staff member as a backup administrator.
   • Helpful characteristics of a Site Administrator:
     • Comfortable with technology
     • Leader or manager
     • Organized
   • You can promote a Site Staff user to a Site Administrator user as a temporary or permanent assignment.
3. Document a business plan or standard operating procedure (SOP) addressing your planned use for SiteVault
   • This assists in communicating any new procedures to your staff as well as guidelines to reference as needed.
   • Common setup SOPs to consider:
     • User Account Management and Training
     • Source/Remote Monitoring
     • Use of Certify as Copy
     • Use of eSignature
     • Use of an eISF
4. Create users
   • Among other benefits, creating user accounts for team members and assigning them to studies enables you to send them documents for electronic signature and training, upload their profile documents, and add them to the digital delegation log.
   • Review the System Roles and Permissions page for access specifics.
   • SiteVault users are assigned one of the following roles:
     • Site Administrator
       • May manage a single site or multiple if part of a research organization overseeing multiple sites’ SiteVault activity.
     • Staff
     • Monitor/External User
     • Site Viewer
   • Add-on permissions are available for staff to have additional visibility/access.

Additional Setup Steps (optional)

• Upload site and staff documentation to the Site Documents eBinder
  • The Site eBinder organizes your site documents or documents that provide evidence of your site’s internal processes and operations.
• Create Person Responsibilities (if an upcoming study is using SiteVault to generate a Delegation of Authority log)
  • The digital delegation process includes assigning standard study responsibilities to site staff. If an upcoming study is utilizing Digital Delegation, it’s helpful to assign responsibilities at the person level during setup. This step will automatically assign those study responsibilities to those individuals when they are assigned to a study using Digital Delegation. This step is not required to move forward with your SiteVault setup.