pediatric-clinical-research/Work Instructions/WI-001-Template.md

Work Instruction: [Title]

Document ID	WI-001
Title	[Title]
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	[DEPARTMENT]

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1. Purpose

[Describe the purpose of this work instruction. If pediatric-specific, indicate applicable age ranges.]

2. Scope

[Define what activities this instruction covers and any age-specific or population-specific limitations.]

3. Safety Precautions

[List safety requirements, especially important for procedures involving children:]

• [Personal protective equipment needed]
• [Hazards to be aware of]
• [Child safety considerations]
• [Parent/guardian presence requirements]
• [Emergency procedures]

4. Equipment/Materials Required

Item	Specification

[For pediatric procedures, specify age-appropriate sizes, child-friendly materials, etc.]

5. Prerequisites

[List required training, certifications, or competencies needed to perform this work instruction]

• [GCP certification]
• [Pediatric-specific training]
• [Procedure-specific competency]

6. Procedure

Step 1: [Title]

[Detailed instructions including child-specific considerations]

Materials needed: [List] Personnel: [Who performs this step] Documentation: [What to record]

Step 2: [Title]

[Detailed instructions]

Age-specific modifications:

• Neonates/Infants: [Specific approach]
• Children: [Specific approach]
• Adolescents: [Specific approach]

Step 3: [Title]

[Detailed instructions]

Step 4: [Additional steps as needed]

[Continue with detailed step-by-step instructions]

7. Pediatric-Specific Considerations

7.1 Age-Appropriate Communication

• [How to explain procedure to child]
• [Language to use]
• [Visual aids or demonstrations]

7.2 Family Involvement

• [Parent/guardian role during procedure]
• [When to request family step out]
• [Family support and reassurance]

7.3 Child Comfort and Cooperation

• [Strategies to reduce anxiety]
• [Distraction techniques]
• [Rewards or positive reinforcement]
• [When to pause or reschedule]

7.4 Developmental Considerations

• [Positioning for different ages]
• [Expected cooperation levels by age]
• [Restraint considerations (if absolutely necessary)]

8. Acceptance Criteria

[Define what constitutes successful completion]

• [Quality standards]
• [Completeness requirements]
• [Child tolerance/comfort]

9. Troubleshooting

Issue	Solution
Child refuses procedure	[Steps to take]
Parent anxious	[Approach]
Technical difficulty	[Resolution]

10. Records

Record	Location	Retention

11. Related Documents

• [Related SOPs]
• [Study protocols]
• [Specifications]
• [Forms]

12. References

[Include relevant pediatric references:]

• [Clinical guidelines]
• [Pediatric standards]
• [Regulatory requirements]

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Revision History

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