# Clinical Research Quality Management System

This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Research Organizations (CROs)**, academic research institutions, and clinical trial sites.

## 🏥 Designed For

- Clinical Research Organizations (CROs)
- Academic Medical Centers
- Clinical Trial Sites
- Biotech/Pharma Research Teams
- IRB/Ethics Committees

## Repository Structure

```
clinical-research-template/
├── Policies/              # Quality policies and management commitment
├── SOPs/                  # Standard Operating Procedures
│   ├── Clinical/          # Clinical trial operations
│   ├── Regulatory/        # Regulatory submissions and compliance
│   ├── Data-Management/   # Clinical data handling
│   └── Safety/            # Adverse event reporting
├── Work Instructions/     # Detailed work instructions
├── Forms/                 # Record forms and templates
│   ├── Informed-Consent/  # ICF templates
│   ├── Case-Report/       # CRF templates
│   └── Monitoring/        # Site monitoring forms
└── Templates/             # Document templates
```

## Document Numbering Convention

- **POL-XXX**: Policies
- **SOP-CL-XXX**: Clinical SOPs
- **SOP-REG-XXX**: Regulatory SOPs
- **SOP-DM-XXX**: Data Management SOPs
- **SOP-SAF-XXX**: Safety SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
- **ICF-XXX**: Informed Consent Forms

## 🤖 AI-Powered Document Creation

This template includes **AtomicAI** integration. Simply create an issue and mention `@atomicai` to:
- Generate new SOPs from descriptions
- Create informed consent templates
- Draft regulatory submission documents
- Update existing documents

## Getting Started

1. Create a new repository using this template
2. Customize documents with your organization's information
3. Create issues with `@atomicai` to generate new documents
4. Review and approve AI-generated content via Pull Requests

## Regulatory Compliance

These templates support compliance with:
- **ICH-GCP E6(R2)** - Good Clinical Practice
- **21 CFR Part 11** - Electronic Records
- **21 CFR Parts 50, 56** - Human Subject Protection
- **HIPAA** - Health Information Privacy
- **GDPR** - Data Protection (EU studies)
- **ISO 14155** - Clinical Investigation of Medical Devices

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