Team Overview
A typical site team includes:| Role | Responsibility |
|---|---|
| Primary Investigator | Overall site responsibility |
| Site Administrator | Administrative management |
| Clinical Research Coordinator | Day-to-day operations |
| Sub Investigator | Clinical assessments |
| Data Entry Specialist | Data entry tasks |
Managing Team Members
Inviting Team Members
Accepting Invitations
When invited:- User receives an email invitation
- User clicks the invitation link
- User signs in or creates an account
- User gains access to the site with assigned role
Users must accept invitations to gain access. Pending invitations can be resent if needed.
Modifying Roles
Removing Team Members
Multiple Roles
Team members can hold multiple roles simultaneously:- PI + Authorized Signer: PI who can sign CRFs
- CRC + Data Entry Specialist: Coordinator with data entry focus
Required Roles
Certain roles are required for site operations:| Requirement | Purpose |
|---|---|
| At least one PI or Deputy PI | Regulatory oversight |
| At least one person who can sign | CRF completion (if signing required) |
Team Visibility
Control what team members can see:| Visibility Level | Access |
|---|---|
| Full Team | View all site team members |
| Role-Based | View based on role permissions |
Delegation
Site administrators can delegate certain tasks:- Team member management
- Workflow completion
- Report generation
Audit Trail
All team changes are recorded:- Who was added or removed
- Role changes
- Who made the change
- When the change occurred
Best Practices
Verify Qualifications
Verify Qualifications
Ensure team members have appropriate qualifications for their assigned roles, especially for PI and Sub-Investigator positions.
Plan for Coverage
Plan for Coverage
Assign backup personnel to ensure coverage during absences.
Regular Reviews
Regular Reviews
Periodically review team composition and remove users who no longer need access.
Document Delegation
Document Delegation
When delegating tasks, ensure proper documentation is in place per your regulatory requirements.
Related
Site Roles
Complete role descriptions and permissions.
CRF Signing
Authorized signer requirements.
