Sync template from atomicqms-style deployment

README.md

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-# clinical-research-template
+# 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
+
+---
+*Powered by AtomicQMS - AI-Enhanced Clinical Research Quality Management*
 
-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.