Study Management

Studies are the core entity in TrialSage. A study represents a clinical trial with a protocol, sites, and subjects.

Creating a Study

From the Studies page, click New Study and fill in:

| Field | Required | Description | |-------|----------|-------------| | Protocol Number | Yes | Unique identifier (e.g., PROTO-001) | | Title | Yes | Descriptive study title | | Phase | No | Phase I, II, III, IV, or Not Applicable | | Sponsor | No | Sponsoring organization | | Therapeutic Area | No | E.g., Oncology, Cardiology | | Description | No | Brief study description |

Study Status Workflow

Studies progress through a defined lifecycle:

Setup → Active → Paused → Closed → Archived
                    ↓
                  Closed

Valid transitions:

• Setup → Active: Study is ready for enrollment
• Active → Paused: Temporarily halt enrollment
• Active → Closed: Study complete or terminated
• Paused → Active: Resume enrollment
• Paused → Closed: End study while paused
• Closed → Archived: Final archival

Each transition is validated server-side and logged to the audit trail.

Editing a Study

Click the Edit button on the study detail page. You can modify:

• Protocol Number, Title, Phase, Sponsor, Therapeutic Area

Status changes use the dedicated transition buttons, not the edit form.

Audit Trail

Every study operation (create, edit, status change, archive) is recorded in an immutable audit trail with:

• Who made the change
• When it happened
• What changed (old value → new value)
• A chained SHA-256 checksum for tamper detection