# Clinical Trials Management

Comprehensive clinical trials management system with protocol management, patient recruitment, and regulatory compliance.

## Features

- **Protocol Management**: Version control, amendments, ICF
- **Patient Recruitment**: Screening, enrollment, randomization
- **Data Collection**: EDC with source document verification
- **Safety Monitoring**: AE/SAE tracking, DSMB reports
- **Regulatory Compliance**: FDA, GCP, ICH guidelines
- **Multi-Site Coordination**: Centralized trial management

## Trial Phases Supported

- Phase I: Safety studies
- Phase II: Efficacy studies
- Phase III: Large-scale trials
- Phase IV: Post-marketing surveillance

## Quick Start

### Create Clinical Trial

```rust
use clinical_trials::*;

let mut trial = ClinicalTrial::new(
    "NCT12345678",
    "Phase III Study of Drug X",
    TrialPhase::PhaseIII
);

trial.add_site("Site 001", "Dr. Smith")?;
trial.activate()?;
```

### Enroll Patient

```python
from clinical_trials import ClinicalTrial, Participant

trial = ClinicalTrial.load("NCT12345678")
participant = trial.screen_patient("PAT-001", inclusion_criteria)

if participant.eligible:
    enrollment = trial.enroll_patient(participant)
    randomization = trial.randomize(enrollment, ["Treatment", "Placebo"])
```

## Data Collection

- Electronic Data Capture (EDC)
- Case Report Forms (CRF)
- Source Document Verification
- Query Management
- Data Monitoring

## Safety Monitoring

- Adverse Event reporting
- Serious Adverse Event (SAE) tracking
- SUSAR reporting
- DSMB meeting preparation

## Regulatory

- FDA 21 CFR Part 11 compliance
- Good Clinical Practice (GCP)
- ICH guidelines
- IRB/EC management
- Informed consent tracking

## Architecture

- 330 lines RDF ontology
- 10 SPARQL queries
- Rust/TypeScript/Python support
- 600+ lines TDD tests

## License

MIT
