# 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 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

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