# Standard Operating Procedure: [Title] | Document ID | SOP-XXX | |-------------|---------| | Title | [Title] | | Revision | 1.0 | | Effective Date | [DATE] | | Author | [AUTHOR] | | Approved By | [APPROVER] | | Department | [DEPARTMENT] | --- ## 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] --- ## Revision History | Rev | Date | Description | Author | |-----|------|-------------|--------| | 1.0 | [DATE] | Initial release | [AUTHOR] |