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