SOP-LAB-002: Vineland-3 Assessment Administration for Pediatric Neurodevelopmental Research #4

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atomicqms-service wants to update the live protocol with 1 changes from claude/issue-3-vineland-sop

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Author SHA1 Message Date
AtomicAI
f497bed744 feat: Add SOP-LAB-002 for Vineland-3 assessment administration
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Create comprehensive standard operating procedure for administering
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) to
pediatric participants with neurodevelopmental disorders.

Key sections include:
- Comprehensive training and competency requirements
- Detailed interview and rating form administration procedures
- Basal and ceiling rules for efficient assessment
- Pediatric and neurodevelopmental-specific considerations
- Quality control and data integrity measures
- Regulatory compliance (FDA 21 CFR Part 11, GCP, HIPAA)
- Deviation management and adverse event handling

Addresses Change Request #3
2025-12-29 14:46:34 +00:00