# ePCR Clinical Trial Enrolment

## Overview

Clinical research workflows often fail in the field not because the science is weak, but because eligible patients are missed during busy operational care. If crews have to remember separate inclusion criteria, separate consent scripts, and separate enrolment logs while treating the patient, trial participation becomes inconsistent and hard to audit.

The ePCR Clinical Trial Enrolment module brings that workflow into the clinical encounter. Services can register active trials with machine-readable eligibility criteria, screen a live encounter against those criteria, capture the consent decision, and maintain a CONSORT-style enrolment flow from eligibility through enrolment without creating a parallel paper process.

```mermaid
flowchart TD
    A[Active Trial Registry] --> B[Encounter Opened]
    B --> C[Eligibility Screening]
    C --> D{Eligible?}
    D -->|No| E[Not Enrolled]
    D -->|Yes| F[Consent Discussion]
    F --> G{Decision}
    G -->|Consented| H[Enrolled]
    G -->|Declined| I[Declined]
    G -->|Unable to Consent| J[Unable to Consent]
    H --> K[CONSORT Flow Record]
    I --> K
    J --> K
```

**Last Reviewed:** 2026-04-17
**Last Updated:** 2026-04-17

## Key Features

- **Trial Registry**: Register trials with sponsor, principal-investigator, active window, and eligibility rules.
- **Machine-Readable Screening**: Screen the active encounter against inclusion and exclusion criteria instead of relying on memory alone.
- **Encounter-Level Match Reasons**: Show why a patient matched a trial so the clinician can understand the screening result quickly.
- **Consent Decision Capture**: Record whether the patient consented, declined, or was unable to consent.
- **Structured Consent Script Support**: Present trial-specific consent guidance in a controlled operational flow.
- **CONSORT-Style Flow Tracking**: Maintain a structured view of assessed, eligible, consented, and enrolled patients for governance and reporting.
- **Organisation Scoping**: Keep trial enrolment activity isolated to the service or organisation running the study.

## Use Cases

- **Time-Critical Pre-Hospital Research**: A live encounter is screened for a study while the clinician is still in the operational workflow.
- **Service-Led Research Programme**: A regional ambulance service runs multiple concurrent studies without separate field paperwork for each one.
- **Governance Review**: Research leads review how many eligible patients were identified, declined, or enrolled for a given trial.
- **Audit-Ready Enrolment Flow**: A sponsor or oversight body receives a structured record of screening and consent outcomes.

## Integration

- **Electronic Patient Care Report Clinical Workspace**: Screening and decision capture happen in the same encounter context as routine care documentation.
- **Signed Documents and Consent Workflows**: Enrolment decisions can align with the service's broader consent and signature processes.
- **Outcome and Research Export Workflows**: Enrolment status can later support research analysis and governance reporting.
- **Identity and Governance Services**: Trial activity can be restricted to the correct service, study team, and oversight users.

## Open Standards

- **CONSORT**: enrolment and reporting can align with the recognised trial-flow model for screened, eligible, and enrolled participants.
- **HL7 FHIR ResearchStudy**: trial definitions can align with the common healthcare-resource model for study metadata.
- **HL7 FHIR ResearchSubject**: enrolled patients can align with a standard representation of study participation.
- **HL7 FHIR Consent**: consent decisions can align with a standard way of representing permissions and restrictions.
- **ISO 14155**: operational use can align with the recognised good-clinical-practice framework for medical-device and clinical investigation workflows.
- **ISO 8601**: screening and consent timestamps use a standard date-time representation.