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README.md

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.

πŸ₯ Designed For

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

Repository Structure

clinical-research-template/
β”œβ”€β”€ Policies/              # Quality policies and management commitment
β”œβ”€β”€ SOPs/                  # Standard Operating Procedures
β”‚   β”œβ”€β”€ Clinical/          # Clinical trial operations
β”‚   β”œβ”€β”€ Regulatory/        # Regulatory submissions and compliance
β”‚   β”œβ”€β”€ Data-Management/   # Clinical data handling
β”‚   └── Safety/            # Adverse event reporting
β”œβ”€β”€ Work Instructions/     # Detailed work instructions
β”œβ”€β”€ Forms/                 # Record forms and templates
β”‚   β”œβ”€β”€ Informed-Consent/  # ICF templates
β”‚   β”œβ”€β”€ Case-Report/       # CRF templates
β”‚   └── 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

πŸ€– 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

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Description
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.
Readme 38 KiB