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
---
*Powered by AtomicQMS - AI-Enhanced Clinical Research Quality Management*
