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Policies/POL-001-Quality-Policy.md

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+# Quality Policy - Pediatric Clinical Research
+
+| Document ID | POL-001 |
+|-------------|---------|
+| Title | Quality Policy - Pediatric Clinical Research |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+
+---
+
+## 1. Policy Statement
+
+[ORGANIZATION NAME] is committed to conducting high-quality pediatric clinical research that protects the rights, safety, and well-being of child participants while advancing medical knowledge to benefit children's health. We maintain a Quality Management System that ensures compliance with applicable regulations and ethical standards specific to pediatric research, while striving for continual improvement.
+
+## 2. Quality Objectives
+
+Our organization commits to:
+
+1. **Child-Centered Research**: Conducting research with the best interests of child participants as the primary consideration
+2. **Ethical Excellence**: Upholding the highest ethical standards, including appropriate assent and parental permission processes
+3. **Regulatory Compliance**: Maintaining compliance with 45 CFR 46 Subpart D, 21 CFR 50 Subpart D, ICH-GCP E6(R2), ICH E11, and all applicable pediatric research regulations
+4. **Scientific Rigor**: Ensuring age-appropriate study designs and methodologies that generate reliable pediatric data
+5. **Safety First**: Implementing enhanced safety monitoring appropriate for pediatric populations
+6. **Family Partnership**: Engaging families as partners in the research process with respect for their time and burden
+7. **Continuous Improvement**: Continually improving our pediatric research capabilities and QMS effectiveness
+8. **Competent Personnel**: Ensuring all personnel have appropriate pediatric research training and expertise
+
+## 3. Pediatric Research Principles
+
+Our organization adheres to the following core principles:
+
+### 3.1 Ethical Protection of Children
+- Research with children is conducted only when necessary and cannot be conducted with adults
+- Direct benefit to child participants or generalizable knowledge about the pediatric population must be clearly demonstrated
+- Risks are minimized and reasonable in relation to anticipated benefits
+- Both parental permission and child assent obtained when appropriate
+- Vulnerable populations receive additional protections
+
+### 3.2 Age-Appropriate Practices
+- Study materials, procedures, and communications developmentally appropriate for each age group
+- Assent processes tailored to child's developmental stage and understanding
+- Recognition that pediatric populations are not homogeneous (neonates, infants, children, adolescents)
+
+### 3.3 Family-Centered Approach
+- Recognition of parents/guardians as essential partners
+- Minimization of family burden and disruption
+- Respect for family dynamics and cultural considerations
+- Transparent communication with families throughout the research
+
+### 3.4 Enhanced Safety Vigilance
+- Heightened monitoring for growth, development, and long-term effects
+- Age-appropriate adverse event assessment
+- Timely reporting and management of safety concerns
+- Data Safety Monitoring Board oversight for higher-risk studies
+
+## 4. Management Commitment
+
+Top management demonstrates commitment to pediatric research quality by:
+
+- Ensuring this quality policy is appropriate to pediatric research operations
+- Ensuring quality objectives align with our mission to advance children's health
+- Integrating QMS requirements into all pediatric research processes
+- Ensuring personnel have appropriate pediatric expertise and training
+- Providing adequate resources for pediatric-specific requirements (child life specialists, age-appropriate facilities, etc.)
+- Promoting ethical conduct and child protection in all research activities
+- Ensuring the QMS achieves protection of child participants and scientific integrity
+- Engaging with pediatric communities, families, and advocates
+- Supporting IRB/Ethics Committee oversight of pediatric research
+
+## 5. Scope
+
+This policy applies to:
+- All clinical research involving children (< 18 years of age, or as defined by local regulations)
+- All employees, contractors, and collaborators conducting pediatric research
+- All processes within our Pediatric Research Quality Management System
+- All study phases from protocol development through closeout and archiving
+
+## 6. Regulatory Framework
+
+This policy encompasses compliance with:
+- 45 CFR 46 Subpart D (Additional Protections for Children Involved in Research)
+- 21 CFR Part 50 Subpart D (Additional Safeguards for Children in Clinical Investigations)
+- ICH-GCP E6(R2) (Good Clinical Practice)
+- ICH E11 (Clinical Investigation of Medicinal Products in the Pediatric Population)
+- 21 CFR Part 11 (Electronic Records; Electronic Signatures)
+- HIPAA and state privacy laws
+- Institutional policies and IRB requirements
+- International regulations for multi-national studies
+
+## 7. Communication and Review
+
+This policy shall be:
+- Communicated to and understood by all personnel involved in pediatric research
+- Made available to families, IRB/Ethics Committees, and regulatory authorities as appropriate
+- Reviewed annually for continuing suitability
+- Updated as needed to reflect evolving pediatric research standards
+
+## 8. Related Documents
+
+- SOP-PED-001 Pediatric Assent Process
+- SOP-PED-002 Parental Permission Requirements
+- SOP-PED-003 Age-Appropriate Study Materials
+- SOP-SAF-001 Pediatric Safety Monitoring
+- POL-002 Human Subject Protection Policy
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |