Available Roles
| Role | Code | Description |
|---|---|---|
| Primary Investigator | primary-investigator | Scientific and regulatory responsibility for the site |
| Site Administrator | site-administrator | Administrative management of site operations |
| Deputy Primary Investigator | deputy-primary-investigator | Supports PI with delegated authority |
| Sub Investigator | sub-investigator | Conducts study procedures under PI supervision |
| Clinical Research Coordinator | clinical-research-coordinator | Coordinates site operations and data collection |
| Data Entry Specialist | data-entry-specialist | Focuses on data entry tasks |
| Site Collaborator | site-collaborator | Read-only access to site information |
| Authorized Signer | authorized-signer | Can sign CRFs and other study documents |
| Local Laboratory Lead | local-laboratory-lead | Manages local lab operations |
| Local Laboratory Member | local-laboratory-member | Performs local lab data entry |
Primary Investigator (PI)
The PI has overall responsibility for the conduct of the study at the site.Capabilities
- Full access to all site data and operations
- Enroll and manage participants
- Review and sign CRFs
- Manage site team members
- View site-level reports and metrics
- Respond to queries
Regulatory Responsibilities
The PI bears regulatory responsibility for the study conduct at their site, including protocol compliance and participant safety.Site Administrator
The Site Administrator handles operational management of the site.Capabilities
- Manage site team roles and invitations
- Configure site-specific settings
- Enroll participants
- Complete workflows and questionnaires
- Access site reports
Deputy Primary Investigator
The Deputy PI supports the PI with delegated authority.Capabilities
- Access all site data
- Enroll and manage participants
- Complete and review questionnaires
- Sign CRFs when authorized
- Respond to queries
Sub Investigator
Sub Investigators conduct study procedures under PI supervision.Capabilities
- Access assigned participant data
- Complete questionnaires
- Perform study assessments
- Respond to queries on their entries
Clinical Research Coordinator (CRC)
CRCs coordinate daily site operations and data collection.Capabilities
- Enroll participants
- Complete all questionnaires and workflows
- Manage participant schedules
- Respond to queries
- Generate site-level reports
Data Entry Specialist
Data Entry Specialists focus specifically on data entry tasks.Capabilities
- Enter data into questionnaires
- Complete assigned workflows
- View participant records
Limitations
- Cannot enroll new participants
- Cannot sign CRFs
- Limited access to site settings
Site Collaborator
Site Collaborators have minimal read-only access.Capabilities
- View site information
- Access shared documents
Limitations
- Cannot enter or modify data
- Cannot view detailed participant records
Authorized Signer
Authorized Signers can sign CRFs and study documents.Capabilities
- Sign completed CRFs
- Sign other study documents requiring signature
- View records they are signing
Authorized Signer is typically assigned in addition to another role. The signing capability adds to their existing permissions.
Local Laboratory Roles
Local Laboratory Lead
- Manage local lab operations
- Enter and verify lab results
- Oversee local lab team members
Local Laboratory Member
- Enter lab results
- View assigned laboratory data
Role Assignment
Site roles are typically assigned during:- Site Registration: When a site self-registers or is manually added
- Team Invitation: When the PI or Site Administrator invites team members
- Role Updates: When team composition changes
Best Practices
Ensure PI Coverage
Ensure PI Coverage
Always have an active PI or Deputy PI available to sign CRFs and handle regulatory responsibilities.
Use CRC for Daily Operations
Use CRC for Daily Operations
Assign CRC roles to staff who will handle regular data entry and participant coordination.
Limit Authorized Signers
Limit Authorized Signers
Related
Service Provider Roles
Roles for external service providers.
CRF Signing
Learn about the CRF signing process.