Study Status
Studies have three primary states:| Status | Description | Allowed Actions |
|---|---|---|
| Draft | Initial configuration state | Full editing, no enrollment |
| Active | Operational state | Enrollment, data collection, amendments |
| Retired | Archived state | Read-only access |
Changing Status
General Settings
Study Information
| Setting | Description |
|---|---|
| Title | Display name shown throughout the platform |
| Identifier | Protocol number or unique study code |
| Description | Summary of study purpose |
| Version | Current protocol version |
Sponsor and Contacts
Configure sponsor information and study contacts for:- Official correspondence
- Shipping addresses
- Primary contact personnel
Participant Settings
Default Participant Status
Set the initial status for newly enrolled participants. Common options:| Status | Use Case |
|---|---|
| Candidate | For studies with screening requirements |
| On Study | For direct enrollment |
| Screening | For studies with formal screening visits |
Participant Registration Portal
Enable self-registration for participants:- Participants can access a public registration page
- Collected information creates candidate records
- Site team reviews and approves registrations
CRF Signing Requirements
Configure whether CRF signing is required:- Enabled: Records require signature from authorized signers before finalization
- Disabled: Records are finalized without signature requirement
Site Settings
Self-Registration
Configure site self-registration:| Option | Description |
|---|---|
| Enabled | Sites can register using a PIN code |
| PIN Code | The code sites use to initiate registration |
| Pre-Registration Workflow | Workflow assigned before registration completes |
| Onboarding Workflow | Workflow assigned after registration approval |
Service Providers
Enable external service providers:- Central laboratories
- Core facilities
- Other centralized services
Data Settings
Protected Health Information
Configure which PHI fields are collected. These settings affect all questionnaires that use PHI fields.Sensitive Data Handling
Configure handling of fields marked as sensitive:- Additional access controls
- Audit logging for sensitive data access
Feature Toggles
Participant-Facing Elements
Enable elements visible to participants:- Participant-facing questionnaires
- Participant portal access
- Self-reported outcomes
Public Information Hub
Enable public-facing study information:- Public study page with general information
- Recruitment materials and contact information
Amendments
Active studies can be amended to update configuration:Make Changes
Modify study configuration as needed. Changes are tracked separately from the live study.
Some changes may require additional steps, such as migrating existing data or updating site configurations.
Related
Study Arms
Configure treatment arms.
Public Info Hub
Set up public study information.