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

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