70 lines
2.4 KiB
Markdown
70 lines
2.4 KiB
Markdown
# Clinical Research Quality Management System
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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.
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## 🏥 Designed For
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- Clinical Research Organizations (CROs)
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- Academic Medical Centers
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- Clinical Trial Sites
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- Biotech/Pharma Research Teams
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- IRB/Ethics Committees
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## Repository Structure
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```
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clinical-research-template/
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├── Policies/ # Quality policies and management commitment
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├── SOPs/ # Standard Operating Procedures
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│ ├── Clinical/ # Clinical trial operations
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│ ├── Regulatory/ # Regulatory submissions and compliance
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│ ├── Data-Management/ # Clinical data handling
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│ └── Safety/ # Adverse event reporting
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├── Work Instructions/ # Detailed work instructions
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├── Forms/ # Record forms and templates
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│ ├── Informed-Consent/ # ICF templates
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│ ├── Case-Report/ # CRF templates
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│ └── Monitoring/ # Site monitoring forms
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└── Templates/ # Document templates
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```
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## Document Numbering Convention
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- **POL-XXX**: Policies
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- **SOP-CL-XXX**: Clinical SOPs
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- **SOP-REG-XXX**: Regulatory SOPs
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- **SOP-DM-XXX**: Data Management SOPs
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- **SOP-SAF-XXX**: Safety SOPs
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- **WI-XXX**: Work Instructions
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- **FRM-XXX**: Forms and Records
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- **ICF-XXX**: Informed Consent Forms
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## 🤖 AI-Powered Document Creation
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This template includes **AtomicAI** integration. Simply create an issue and mention `@atomicai` to:
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- Generate new SOPs from descriptions
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- Create informed consent templates
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- Draft regulatory submission documents
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- Update existing documents
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## Getting Started
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1. Create a new repository using this template
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2. Customize documents with your organization's information
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3. Create issues with `@atomicai` to generate new documents
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4. Review and approve AI-generated content via Pull Requests
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## Regulatory Compliance
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These templates support compliance with:
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- **ICH-GCP E6(R2)** - Good Clinical Practice
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- **21 CFR Part 11** - Electronic Records
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- **21 CFR Parts 50, 56** - Human Subject Protection
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- **HIPAA** - Health Information Privacy
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- **GDPR** - Data Protection (EU studies)
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- **ISO 14155** - Clinical Investigation of Medical Devices
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---
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*Powered by AtomicQMS - AI-Enhanced Clinical Research Quality Management*
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