Sync template from atomicqms-style deployment

README.md

@@ -1,3 +1,136 @@
-# pediatric-clinical-research
+# Pediatric Clinical Research Quality Management System
 
-This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Pediatric Clinical Research**, with focus on the unique regulatory, ethical, and operational requirements for research involving chi
+This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Pediatric Clinical Research**, with focus on the unique regulatory, ethical, and operational requirements for research involving children.
+
+## Designed For
+
+- Pediatric Clinical Research Organizations (CROs)
+- Children's Hospitals and Academic Medical Centers
+- Pediatric Clinical Trial Sites
+- Pharmaceutical/Biotech Pediatric Development Programs
+- Pediatric Research Networks
+- IRB/Ethics Committees reviewing pediatric research
+
+## Repository Structure
+
+```
+pediatric-clinical-research/
+├── 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
+│   └── Pediatric-Specific/ # Pediatric-specific procedures
+├── Work Instructions/     # Detailed work instructions
+├── Forms/                 # Record forms and templates
+│   ├── Assent-Forms/      # Age-appropriate assent templates
+│   ├── Parental-Permission/ # Parental permission templates
+│   ├── Case-Report/       # Pediatric CRF templates
+│   ├── Monitoring/        # Site monitoring forms
+│   └── Safety-Monitoring/ # Pediatric safety monitoring
+└── 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
+- **SOP-PED-XXX**: Pediatric-Specific SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms and Records
+- **ASF-XXX**: Assent Forms
+- **PPF-XXX**: Parental Permission Forms
+- **ICF-XXX**: Informed Consent Forms (for parents/LAR)
+
+## AI-Powered Document Creation
+
+This template includes **AtomicAI** integration specialized for pediatric research. Simply create an issue and mention `@atomicai` to:
+- Generate pediatric-specific SOPs
+- Create age-appropriate assent forms
+- Draft parental permission documents
+- Develop pediatric safety monitoring plans
+- Update existing documents with pediatric considerations
+
+## 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 pediatric research documents
+4. Review and approve AI-generated content via Pull Requests
+
+## Pediatric Age Classifications
+
+This template uses standard pediatric age classifications:
+
+| Age Group | Definition |
+|-----------|------------|
+| **Neonates** | Birth to 28 days |
+| **Infants** | 29 days to < 2 years |
+| **Children** | 2 to < 12 years |
+| **Adolescents** | 12 to < 18 years (or < 21 in some jurisdictions) |
+
+## Key Pediatric Research Considerations
+
+### Ethical Protections
+- **45 CFR 46 Subpart D**: Additional protections for children in research
+- **21 CFR 50 Subpart D**: Additional safeguards for children
+- Both parental permission AND child assent typically required
+- Minimal risk threshold assessed differently for pediatric population
+- Direct benefit to child must be clearly articulated
+
+### Regulatory Frameworks
+- **ICH E11**: Clinical Investigation of Medicinal Products in the Pediatric Population
+- **Pediatric Research Equity Act (PREA)**: Requires pediatric studies for certain new drugs/biologics
+- **Best Pharmaceuticals for Children Act (BPCA)**: Incentivizes pediatric drug studies
+- **FDA Pediatric Study Plans (PSP)**: Required planning documents for pediatric investigations
+
+### Operational Considerations
+- Age-appropriate assent processes and materials
+- Parental permission requirements (one vs. two parents)
+- School/education coordination for study visits
+- Growth and development monitoring
+- Pediatric dosing and pharmacokinetics
+- Adolescent-specific issues (emancipated minors, reproductive health)
+- Family-centered care approaches
+- Minimizing caregiver burden
+
+### Safety Monitoring
+- Enhanced safety monitoring requirements
+- Growth and development assessments
+- Long-term follow-up considerations
+- Pediatric-specific adverse events
+- Data Safety Monitoring Board (DSMB) requirements
+- Expedited reporting timelines
+
+## Regulatory Compliance
+
+These templates support compliance with:
+
+- **45 CFR 46 Subpart D** - Additional Protections for Children
+- **21 CFR Part 50 Subpart D** - Additional Safeguards for Children
+- **ICH-GCP E6(R2)** - Good Clinical Practice
+- **ICH E11** - Pediatric Clinical Investigations
+- **21 CFR Part 11** - Electronic Records
+- **21 CFR Parts 50, 56** - Human Subject Protection
+- **HIPAA** - Health Information Privacy
+- **COPPA** - Children's Online Privacy Protection Act (if applicable)
+- **GDPR** - Data Protection (EU studies)
+
+## Special Populations
+
+This template addresses:
+- Neonatal intensive care research
+- Pediatric oncology studies
+- Rare pediatric diseases
+- Emergency research in children
+- Genetic/genomic research in pediatrics
+- Mental health research with minors
+- Adolescent reproductive health research
+
+---
+
+*Powered by AtomicQMS - AI-Enhanced Pediatric Clinical Research Quality Management*