Subject Management

Subjects are the participants enrolled in clinical trials at specific sites.

Enrolling a Subject

From a study's detail page, click Enroll Subject and provide:

| Field | Required | Description | |-------|----------|-------------| | Site | Yes | Select the site for enrollment | | Subject Number | Yes | Unique subject identifier (e.g., SUBJ-001) | | Consent Date | Yes | Date informed consent was obtained | | Consent Version | Yes | Version of the consent form signed | | Screening Date | No | Date screening began |

Subject Status Lifecycle

screening → enrolled → active → completed
    ↓                     ↓
screen_failed          withdrawn
                          ↓
                    lost_to_followup

When a subject transitions to:

• enrolled — enrollment date is automatically set
• completed — completion date is automatically set
• withdrawn — withdrawal date is automatically set

Viewing Subjects

The study detail page shows a table of all subjects with:

• Subject number
• Status (color-coded: green for enrolled/active, red for withdrawn)
• Consent date
• Enrollment date

Audit Trail

Every subject operation is logged with the same immutable audit trail as studies — who, when, what changed, with chained checksums.