eReg Knowledge Base

Study Team Assignments

Learn how to create and manage Study Team Assignments.

Note Only SiteVault users with the Site Administrator system role can complete the tasks on this page.

Study Team Assignments

  • Creating a Study Team Assignment assigns a site staff user to a study.
  • An assignment grants the site staff user access to view a study and the study-related documents.
  • To create a Study Team Assignment, the user must already have a SiteVault account for your site.
  • Study Team Assignments can be managed in the following areas of SiteVault eReg:
    • Study > Study Team Assignments
    • Administration > Staff
  • Study Team Assignment States
    • Four possible states for a Study Team Assignment are available: Proposed, Active, Make Inactive (Digital Delegation only), and Inactive.
    • Study Team Assignments are created in the Proposed state.
    • Study Team Assignments can toggle between Active and Inactive.
    • Study Team Assignments can only be deleted in the Proposed state.
    • When an Assignment is updated to the Active state, the user’s most recent steady-state version and any subsequent versions of their profile documents (for example, CV and licenses) are added to the study.
    • When a Study Team Assignment with the role of Principal Investigator is changed to Active, the Principal Investigator (PI) field on the study is automatically updated to that PI.

Digital Delegation and Study Team Assignments

  • Studies utilizing SiteVault Digital Delegation use Study Team Assignments as part of the delegated responsibilities approval process.
  • When you update the assigned PI on the study, the status of any existing study delegations are updated to Accepted - PI Approval Needed. The delegations will become active again when the new PI approves.
  • Study Team Assignment Start Date-Time and End Date-Time Fields
    • Admins can edit the date fields when the study staff member is in one of the following states:
      • Proposed
      • Proposed Changes - Acceptance Needed
    • These fields are present when Digital Delegation is enabled on a study.
    • When an assignment moves to the Active state and the Start Date-Time field is empty, the field is populated with the current date.
    • When an assignment moves to the Inactive state and the End Date-Time field is empty, the field is populated with the current date.
    • When an assignment moves to the Make Inactive state, any delegation end date-time fields that are empty or reflect an end date-time after the assignment end date-time, are updated to the assignment end date-time.

For more on Study Team Assignments, see the Assigning Study Teams, Partner Organizations, and Products training video.


Study Team Assignment Tasks

Create Study Team Assignment(s)

You can create assignments from Administration > Staff > Study Assignments or Study > Study Team Assignments. Complete the following steps to create assignments from Study > Study Team Assignments:

  1. Navigate to the Studies tab.
  2. Locate and select the study from the Study Identifier column.
  3. Expand the Study Team Assignment section.
  4. Select the +Assign button.
  5. Select staff to assign or select a study from the Copy from Another Study field to use assignments from an existing study.
  6. Select or update the assignment role(s).
    • Note: When a Study Team Assignment with the role of Principal Investigator is changed to Active, the Principal Investigator (PI) field on the study is automatically updated to that PI.
  7. Select Next.
  8. If available, complete the Start Date-Time field.
    • If not completed, the field is automatically populated with the date the staff study assignment became Active in SiteVault.
  9. If applicable, complete the End Date-Time field.
    • If not completed, the field is automatically populated with the date the staff study assignment became Inactive in SiteVault.
  10. Select Save to complete the process.
  11. If appropriate, change the assignment(s) to Active.

Create Multiple Study Team Assignments for a Staff Member

Assign multiple studies to a staff member in a single process. Ideal for getting a newly hired staff member assigned to the relevant studies.

  1. Navigate to Administration > Staff.
  2. Select the staff member to update.
  3. Expand the Study Assignments section.
  4. Select +Assign.
  5. Select a site from the Site Selector.
  6. Select +Add Study.
  7. Use the available filters to sort the study list.
  8. Select the studies to assign.
  9. Select Save.
  10. Assign the Study Role for each study.
    • To select the same role for all of the selected studies, select the role from the Study Role Selector (top Study Role row).
    • To assign a different role for individual studies, search for each study and select the role from the associated Study Role field.
  11. Select Save to complete the process.
  12. If appropriate, change the assignment to Active.

Edit Study Team Assignment

You can edit an assignment from Administration > Staff >Study Assignments or the Study > Study Team Assignments section. Complete the following steps to change a Study Team Assignment

  1. Navigate to the Studies tab.
  2. Locate and select the study from the Study Identifier column.
  3. Expand the Study Team Assignment section.
  4. Locate and select the Study Team Assignment requiring an update.
  5. Select Edit from the All Actions menu.
  6. Update the fields as needed.
  7. Select Save to complete the process.

Change Principal Investigator (PI) on a Study

Digital Delegations Studies: When you update the assigned PI on the study, the status of any existing study delegations are updated to Accepted - PI Approval Needed. The delegations will become active again when the new PI approves.

Complete the following steps to change the PI on a Study:

Change the Current PI Assignment to Inactive

  1. Navigate to the Studies tab.
  2. Locate and select the study from the Study Identifier column.
  3. Expand the Study Team Assignment section.
  4. Locate and select the Study Team Assignment for the current PI.
  5. If available, complete the End Date-Time field.
    • If not completed, the field is automatically populated with the date the staff study assignment became Inactive in SiteVault.
  6. From the Workflow Actions menu, change the state of the Study Team Assignment to Inactive.

Update the New PI Assignment

  1. Return to the Study Team Assignment section.
  2. If the new PI:
    • Has an existing Study Team Assignment for the study
      • Open the existing Study Team Assignment.
      • Select Edit from the All Actions menu.
      • Change the Study Role field to Principal Investigator.
      • Select Save to complete the process.
      • If the state is:
        • Inactive, go to step 9.
        • Active, no additional steps are required.
    • Does not have have an existing Study Team Assignment for the study
      • Continue to the next step.
  3. Select the +Assign button.
  4. Complete the Study Role field.
  5. Complete the User field.
  6. If available, complete the Start Date-Time field.
    • If not completed, the field is automatically populated with the date the staff study assignment became Active in SiteVault.
  7. If applicable, complete the End Date-Time field.
    • If not completed, the field is automatically populated with the date the staff study assignment became Inactive in SiteVault.
  8. Select Save to complete the process.
  9. From the Workflow Actions menu, change the state of the Study Team Assignment to Active.

Change Study Team Assignment State

You can edit an assignment’s state from Administration > Staff >Study Assignments or the Study > Study Team Assignments section. Complete the following steps to change an assignment state from Study > Study Team Assignment:

  1. Navigate to the Studies tab
  2. Expand the Study Team Assignment section.
  3. Locate and select the Study Team Assignment.
  4. From the Workflow Actions menu, select the appropriate lifecycle state.

Delete Study Team Assignment

Study team assignments can only be deleted in the Proposed state.

Complete the following steps to delete a Study Team Assignment.

  1. Navigate to the Studies tab.
  2. Locate and select the study from the Study Identifier column.
  3. Expand the Study Team Assignment section.
  4. Locate and select the Study Team Assignment requiring deletion.
  5. Select Delete from the All Actions menu.
  6. Select Continue to confirm your intent.



Creating and Managing Studies
Monitor & Auditor Assignments
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