Learn how to create and manage Monitor & Auditor Assignments.
Monitor & Auditor Assignments
- Creating a Monitor & Auditor Assignment assigns an external user to a study.
- An assignment grants the user access to view study-related documents.
- To create a Monitor & Auditor Assignment, the user must already have a SiteVault account for your site. See Create a Monitor or External User.
- Monitor & Auditor Assignments can be viewed in the following areas of SiteVault eReg:
- Study > Monitor & Auditor Assignments
- Administration > Monitors & External Users
- Monitor & Auditor States
- Monitor & Auditor Assignments are created in the Active state unless a future date is entered in the Scheduled Access Start Date field.
- The assignment begins in the Inactive state when a future date is entered in the Scheduled Access Start Date field.
- The Scheduled Acces Start Date cannot be a date in the past.
- When a Monitor or External User loses access to a site, any Study Assignments for that user (at that site) are moved to the Inactive state.
Monitor & Auditor Assignment Tasks
Create Monitor & Auditor Assignment
Complete the following steps to create a Monitor & Auditor Assignment.
- Navigate to the Studies tab.
- Locate and select the study from the Study Identifier column.
- Expand the Monitor & Auditor Assignments section.
- Select the Create button.
- Complete the Study Role field.
- Complete the User field.
- Complete the Scheduled Access Start field if access starts on a date other than today
- If not completed, the field is automatically populated with the assignment creation date.
- If applicable, complete the Schedule Access End field.
- If not completed, the field is automatically populated with the date the Monitor & Auditor Assignment becomes Inactive in SiteVault.
- Select Save to complete the process.
Edit Monitor & Auditor Assignment
Complete the following steps to change a Monitor & Auditor Assignment.
- Navigate to the Studies tab.
- Locate and select the study from the Study Identifier column.
- Expand the Monitor & Auditor Assignment section.
- Locate and select the Monitor & Auditor Assignment requiring an update.
- Select Edit from the All Actions menu.
- Update the fields as needed.
- Select Save to complete the process.
Change Monitor or Auditor Assignment Status
Complete the following steps to update an existing Monitor or Auditor Study Assignment status.
From the Studies Tab
- Locate and select the study.
- Expand the Monitor & Auditor Assignments section.
- Select the user record from the User Assigned column.
- From the Workflow Actions menu, select the appropriate lifecycle state.
- Select Save to complete the process.
From the Administration Tab
- Open the Monitors & External User tab.
- Locate and select the user from the Name column.
- Expand the Study Assignments section.
- Locate the site and study.
- Change the status using the Lifecycle State button in the Assignment Status column.