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

atomicqms-service commented

2025-12-29 09:47:27 -05:00

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Document Review Summary

This Document Review introduces SOP-LAB-002: Standard Operating Procedure for Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Administration for use with pediatric participants with neurodevelopmental disorders in research settings.

What's New

New SOP: SOPs/Lab/SOP-LAB-002-Vineland-3-Assessment.md
Document Number: SOP-LAB-002 (following the lab SOP numbering convention)
Status: Draft (awaiting approval)

Document Highlights

Comprehensive Coverage

This SOP provides detailed guidance for research teams administering the Vineland-3 assessment, including:

Training Requirements: Minimum 4 hours of Vineland-3 training with competency verification (3 supervised administrations, 95% scoring accuracy)
Administration Procedures:
- Interview Form administration (comprehensive step-by-step guidance)
- Parent/Caregiver Rating Form procedures
- Basal and ceiling rules for efficient assessment
- Pediatric-specific considerations for children with neurodevelopmental disorders
Quality Controls:
- Independent scoring verification (10% of assessments)
- Inter-rater reliability monitoring (≥90% target)
- Documentation of unusual response patterns
Regulatory Compliance:
- FDA 21 CFR Part 11 (electronic records)
- ICH E6(R2) Good Clinical Practice
- HIPAA Privacy Rule
- Human subjects protection
Special Considerations for Neurodevelopmental Populations:
- Guidance on scoring with adaptive equipment
- Handling behavioral variability
- Cultural sensitivity in adaptive behavior assessment
- Documentation of unique circumstances

Alignment with Existing SOPs

This SOP follows the same structure and quality standards as SOP-LAB-001 (Pediatric Blood Draws), ensuring consistency across your laboratory procedures.

Regulatory Compliance Notes

✅ Includes required training and competency documentation
✅ Addresses FDA 21 CFR Part 11 for electronic data systems
✅ Incorporates GCP principles (ICH E6(R2))
✅ Defines clear roles and responsibilities
✅ Establishes deviation management procedures
✅ Includes quality control and auditing requirements

Recommended Next Steps

Review this SOP with your licensed psychologist or assessment supervisor
Customize sections marked with "" (author names, approval signatures)
Verify software and licensing details match your institution's setup
Train your research team using this SOP
Approve and finalize the document through your QMS approval workflow

Questions to Consider During Review

Do the training requirements align with your institutional standards?
Are the respondent selection criteria appropriate for your study population?
Does the quality control frequency (10% verification) meet your needs?
Should any additional safety or cultural considerations be added?

Related Change Request: Addresses #3
Document Type: Standard Operating Procedure
Target Audience: Pediatric research teams conducting neurodevelopmental assessments

## Document Review Summary This Document Review introduces **SOP-LAB-002: Standard Operating Procedure for Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Administration** for use with pediatric participants with neurodevelopmental disorders in research settings. ## What's New - **New SOP**: `SOPs/Lab/SOP-LAB-002-Vineland-3-Assessment.md` - **Document Number**: SOP-LAB-002 (following the lab SOP numbering convention) - **Status**: Draft (awaiting approval) ## Document Highlights ### Comprehensive Coverage This SOP provides detailed guidance for research teams administering the Vineland-3 assessment, including: 1. **Training Requirements**: Minimum 4 hours of Vineland-3 training with competency verification (3 supervised administrations, 95% scoring accuracy) 2. **Administration Procedures**: - Interview Form administration (comprehensive step-by-step guidance) - Parent/Caregiver Rating Form procedures - Basal and ceiling rules for efficient assessment - Pediatric-specific considerations for children with neurodevelopmental disorders 3. **Quality Controls**: - Independent scoring verification (10% of assessments) - Inter-rater reliability monitoring (≥90% target) - Documentation of unusual response patterns 4. **Regulatory Compliance**: - FDA 21 CFR Part 11 (electronic records) - ICH E6(R2) Good Clinical Practice - HIPAA Privacy Rule - Human subjects protection 5. **Special Considerations for Neurodevelopmental Populations**: - Guidance on scoring with adaptive equipment - Handling behavioral variability - Cultural sensitivity in adaptive behavior assessment - Documentation of unique circumstances ### Alignment with Existing SOPs This SOP follows the same structure and quality standards as SOP-LAB-001 (Pediatric Blood Draws), ensuring consistency across your laboratory procedures. ## Regulatory Compliance Notes - ✅ Includes required training and competency documentation - ✅ Addresses FDA 21 CFR Part 11 for electronic data systems - ✅ Incorporates GCP principles (ICH E6(R2)) - ✅ Defines clear roles and responsibilities - ✅ Establishes deviation management procedures - ✅ Includes quality control and auditing requirements ## Recommended Next Steps 1. **Review** this SOP with your licensed psychologist or assessment supervisor 2. **Customize** sections marked with "" (author names, approval signatures) 3. **Verify** software and licensing details match your institution's setup 4. **Train** your research team using this SOP 5. **Approve** and finalize the document through your QMS approval workflow ## Questions to Consider During Review - Do the training requirements align with your institutional standards? - Are the respondent selection criteria appropriate for your study population? - Does the quality control frequency (10% verification) meet your needs? - Should any additional safety or cultural considerations be added? --- **Related Change Request**: Addresses #3 **Document Type**: Standard Operating Procedure **Target Audience**: Pediatric research teams conducting neurodevelopmental assessments

atomicqms-service added 1 commit 2025-12-29 09:47:28 -05:00

feat: Add SOP-LAB-002 for Vineland-3 assessment administration

AtomicAI Tutorial Assistant / claude-assistant (pull_request) Has been skipped

Details

f497bed744

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