pediatric-clinical-research/Templates/SOP-Template.md

Standard Operating Procedure: [Title]

Document ID	SOP-XXX
Title	[Title]
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	[DEPARTMENT]

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1. Purpose

[State the purpose of this procedure. For pediatric research procedures, specify if applicable to specific age groups.]

2. Scope

[Define the scope and applicability. Indicate age ranges, study types, or specific pediatric populations if applicable.]

3. Responsibilities

3.1 [Role 1]

• [Responsibility]
• [Responsibility]

3.2 [Role 2]

• [Responsibility]
• [Responsibility]

3.3 [Additional roles as needed]

• [Responsibility]
• [Responsibility]

4. Definitions

Term	Definition

5. Procedure

5.1 [Section Title]

[Procedure steps - for pediatric procedures, include age-specific considerations]

1. [Step]
2. [Step]
3. [Step]

5.2 [Section Title]

[Additional procedure steps]

5.3 Pediatric-Specific Considerations (if applicable)

[Address age-appropriate modifications, developmental considerations, family involvement, etc.]

6. Special Considerations for Age Groups (if applicable)

6.1 Neonates (Birth to 28 days)

[Specific considerations]

6.2 Infants (29 days to < 2 years)

[Specific considerations]

6.3 Children (2 to < 12 years)

[Specific considerations]

6.4 Adolescents (12 to < 18 years)

[Specific considerations]

7. Related Documents

• [List related procedures, forms, protocols, etc.]

8. References

[Include pediatric-specific regulatory references where applicable:]

• [45 CFR 46 Subpart D - if related to human subjects protection]
• [21 CFR 50 Subpart D - if related to informed consent/assent]
• [ICH E11 - if related to pediatric drug development]
• [External standards, regulations, guidelines, etc.]

9. Appendices (if applicable)

Appendix A: [Title]

[Content]

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Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]