99 lines
2.1 KiB
Markdown
99 lines
2.1 KiB
Markdown
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# Standard Operating Procedure: [Title]
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| Document ID | SOP-XXX |
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|-------------|---------|
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| Title | [Title] |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | [DEPARTMENT] |
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---
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## 1. Purpose
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[State the purpose of this procedure. For pediatric research procedures, specify if applicable to specific age groups.]
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## 2. Scope
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[Define the scope and applicability. Indicate age ranges, study types, or specific pediatric populations if applicable.]
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## 3. Responsibilities
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### 3.1 [Role 1]
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- [Responsibility]
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- [Responsibility]
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### 3.2 [Role 2]
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- [Responsibility]
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- [Responsibility]
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### 3.3 [Additional roles as needed]
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- [Responsibility]
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- [Responsibility]
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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## 5. Procedure
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### 5.1 [Section Title]
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[Procedure steps - for pediatric procedures, include age-specific considerations]
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1. [Step]
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2. [Step]
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3. [Step]
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### 5.2 [Section Title]
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[Additional procedure steps]
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### 5.3 Pediatric-Specific Considerations (if applicable)
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[Address age-appropriate modifications, developmental considerations, family involvement, etc.]
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## 6. Special Considerations for Age Groups (if applicable)
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### 6.1 Neonates (Birth to 28 days)
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[Specific considerations]
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### 6.2 Infants (29 days to < 2 years)
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[Specific considerations]
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### 6.3 Children (2 to < 12 years)
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[Specific considerations]
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### 6.4 Adolescents (12 to < 18 years)
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[Specific considerations]
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## 7. Related Documents
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- [List related procedures, forms, protocols, etc.]
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## 8. References
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[Include pediatric-specific regulatory references where applicable:]
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- [45 CFR 46 Subpart D - if related to human subjects protection]
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- [21 CFR 50 Subpart D - if related to informed consent/assent]
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- [ICH E11 - if related to pediatric drug development]
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- [External standards, regulations, guidelines, etc.]
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## 9. Appendices (if applicable)
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### Appendix A: [Title]
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[Content]
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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