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

Create a new repository using this template
Customize documents with your organization's information
Create issues with @atomicai to generate new documents
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

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