new protocol #3

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opened 2025-12-29 09:42:58 -05:00 by drpedapati · 1 comment

drpedapati commented

2025-12-29 09:42:58 -05:00

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@atomicai Hey, draft me an SOP specifically for collecting Vineland version 3 in kids with neurodevelopmental disorders for our pediatric research team.

atomicqms-service commented

2025-12-29 09:43:05 -05:00

AtomicAI finished @drpedapati's task —— View job

✅ Vineland-3 SOP Created Successfully!

I've drafted a comprehensive Standard Operating Procedure for administering the Vineland-3 assessment to children with neurodevelopmental disorders!

What I Created

📄 Document: SOPs/Lab/SOP-LAB-002-Vineland-3-Assessment.md

This SOP provides complete guidance for your pediatric research team, including:

Training & Competency: Minimum 4-hour training requirement with documented competency verification (3 supervised administrations at 95% accuracy)
Administration Procedures: Step-by-step instructions for both Interview Form and Parent/Caregiver Rating Form
Scoring Guidelines: Basal and ceiling rules, quality control procedures, and data entry requirements
Pediatric Considerations: Special guidance for children with neurodevelopmental disorders, including adaptive equipment use and behavioral variability
Regulatory Compliance: FDA 21 CFR Part 11, ICH GCP, HIPAA, and human subjects protection
Quality Controls: Independent scoring verification (10% of assessments) and inter-rater reliability monitoring

📚 Educational Notes for You

Understanding AtomicQMS Workflow:

Working Draft Created: I created branch claude/issue-3-vineland-sop with your new SOP
Document Review Initiated: Created Document Review #4 for approval
QMS Approval Process: This follows your document control procedures - the SOP needs review and approval before becoming effective

Following Your Repository Conventions:

✅ Placed in SOPs/Lab/ directory (matching your lab procedures pattern)
✅ Used document number SOP-LAB-002 (following SOP-LAB-001)
✅ Matched the structure of your existing pediatric blood draw SOP
✅ Included YAML frontmatter with document metadata
✅ Set status as "Draft" pending approval

Key Sections to Customize:

Section 16 (Version Control): Add author name
Approval Signatures table: Add your PI, psychologist, and QA names
Software details (Section 7): Verify Q-global licensing matches your setup
Training requirements (Section 6): Adjust if your institution has different standards

Next Steps

Review the Document Review at PR #4
Provide feedback if any sections need adjustment for your specific study
Customize author and approval signature sections
Approve and merge when ready to make it an effective document in your QMS

🎓 Learning Opportunity

This is a great example of how AtomicQMS uses Git workflows for quality management:

Version Control: Every change is tracked with full audit trail
Review Process: Document Reviews ensure multi-person oversight
Traceability: This SOP links back to Change Request #3
Regulatory Ready: Built-in compliance with FDA and ICH standards

Feel free to experiment with the document in this sandbox! You can request changes, add comments in the Document Review, or ask me to adjust any sections.

Branch: claude/issue-3-vineland-sop
Document Review: #4 - SOP-LAB-002

**AtomicAI finished @drpedapati's task** —— [View job](https://beta.atomicqms.com/drpedapati/getting-started/actions/runs/5) --- ### ✅ Vineland-3 SOP Created Successfully! I've drafted a comprehensive Standard Operating Procedure for administering the Vineland-3 assessment to children with neurodevelopmental disorders! ### What I Created **📄 Document**: `SOPs/Lab/SOP-LAB-002-Vineland-3-Assessment.md` This SOP provides complete guidance for your pediatric research team, including: - **Training & Competency**: Minimum 4-hour training requirement with documented competency verification (3 supervised administrations at 95% accuracy) - **Administration Procedures**: Step-by-step instructions for both Interview Form and Parent/Caregiver Rating Form - **Scoring Guidelines**: Basal and ceiling rules, quality control procedures, and data entry requirements - **Pediatric Considerations**: Special guidance for children with neurodevelopmental disorders, including adaptive equipment use and behavioral variability - **Regulatory Compliance**: FDA 21 CFR Part 11, ICH GCP, HIPAA, and human subjects protection - **Quality Controls**: Independent scoring verification (10% of assessments) and inter-rater reliability monitoring ### 📚 Educational Notes for You **Understanding AtomicQMS Workflow**: 1. **Working Draft Created**: I created branch `claude/issue-3-vineland-sop` with your new SOP 2. **Document Review Initiated**: Created [Document Review #4](https://beta.atomicqms.com/drpedapati/getting-started/pulls/4) for approval 3. **QMS Approval Process**: This follows your document control procedures - the SOP needs review and approval before becoming effective **Following Your Repository Conventions**: - ✅ Placed in `SOPs/Lab/` directory (matching your lab procedures pattern) - ✅ Used document number **SOP-LAB-002** (following SOP-LAB-001) - ✅ Matched the structure of your existing pediatric blood draw SOP - ✅ Included YAML frontmatter with document metadata - ✅ Set status as "Draft" pending approval **Key Sections to Customize**: - Section 16 (Version Control): Add author name - Approval Signatures table: Add your PI, psychologist, and QA names - Software details (Section 7): Verify Q-global licensing matches your setup - Training requirements (Section 6): Adjust if your institution has different standards ### Next Steps 1. **Review** the Document Review at [PR #4](https://beta.atomicqms.com/drpedapati/getting-started/pulls/4) 2. **Provide feedback** if any sections need adjustment for your specific study 3. **Customize** author and approval signature sections 4. **Approve and merge** when ready to make it an effective document in your QMS ### 🎓 Learning Opportunity This is a great example of how AtomicQMS uses Git workflows for quality management: - **Version Control**: Every change is tracked with full audit trail - **Review Process**: Document Reviews ensure multi-person oversight - **Traceability**: This SOP links back to Change Request #3 - **Regulatory Ready**: Built-in compliance with FDA and ICH standards Feel free to experiment with the document in this sandbox! You can request changes, add comments in the Document Review, or ask me to adjust any sections. --- **Branch**: [`claude/issue-3-vineland-sop`](https://beta.atomicqms.com/drpedapati/getting-started/src/branch/claude/issue-3-vineland-sop) **Document Review**: [#4 - SOP-LAB-002](https://beta.atomicqms.com/drpedapati/getting-started/pulls/4)