generated from atomicai/getting-started
94 lines
3.7 KiB
Markdown
94 lines
3.7 KiB
Markdown
---
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title: "Standard Operating Procedure for Administering the Child Sensory Profile"
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author: ""
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date: 2026-01-05
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version: "1.0"
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status: "Draft"
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---
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## 1. Purpose
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The purpose of this Standard Operating Procedure (SOP) is to define standardized processes for administering the Child Sensory Profile (CSP) as part of the IRB-approved research protocol FX-ROOTS. This SOP ensures consistency, data integrity, participant protection, and compliance with applicable institutional policies.
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## 2. Scope
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This SOP applies to all authorized personnel involved in the administration, scoring, handling, and storage of Child Sensory Profile assessments conducted under the FX-ROOTS research protocol.
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## 3. Regulatory and Institutional Compliance
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This SOP is designed to comply with the following:
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- Institutional policies governing human subjects research
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- IRB-approved protocol FX-ROOTS
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*If certain regulations are not applicable, document justification per institutional policy.*
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## 4. Definitions and Abbreviations
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TermDefinitionChild Sensory ProfileA standardized caregiver-reported assessment evaluating a child’s sensory processing patternsCSPChild Sensory ProfileIRBInstitutional Review Board
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## 5. Roles and Responsibilities
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RoleResponsibilitiesResearch StaffAdminister CSP, ensure protocol compliance, maintain data confidentialityStudentsAdminister CSP under supervision, complete required training, follow this SOPPrincipal InvestigatorOversight of SOP adherence and IRB compliance
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## 6. Authorization and Training
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- Only authorized research_staff and students may administer the CSP.
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- Personnel must complete required human subjects research and protocol-specific training prior to administration.
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- Training records must be maintained according to institutional policy.
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## 7. Materials and Equipment
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- Authorized version of the Child Sensory Profile (paper or electronic)
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- Participant information sheet and consent documentation
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- Data collection tools (e.g., secure database, scoring software)
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- Secure storage system for completed assessments
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## 8. Procedure
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### 8.1 Pre-Administration
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- Verify IRB approval and participant eligibility.
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- Confirm informed consent has been obtained and documented.
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- Assign a unique participant identifier.
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- Prepare CSP materials and ensure a quiet, distraction-free environment.
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### 8.2 Administration
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- Provide standardized instructions to the caregiver as outlined in the CSP manual.
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- Answer procedural questions without influencing responses.
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- Ensure the caregiver completes all required items.
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- Monitor for incomplete or inconsistent responses.
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### 8.3 Post-Administration
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- Review the CSP for completeness.
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- Score the assessment according to the official scoring guidelines.
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- Document administration date, administrator name, and any deviations.
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- Address missing data per protocol guidance.
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## 9. Data Management and Confidentiality
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- Store completed assessments in secure, access-controlled systems.
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- Electronic records must follow institutional data security requirements.
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- De-identify data prior to analysis when required.
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- Retain records according to IRB and institutional retention schedules.
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## 10. Quality Assurance and Deviations
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- Periodic audits may be conducted to ensure SOP adherence.
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- Deviations must be documented and reported to the Principal Investigator.
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- Corrective actions should be implemented as needed.
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## 11. Safety and Ethical Considerations
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- Respect participant privacy and confidentiality at all times.
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- Discontinue administration if participant distress is observed and follow protocol guidance.
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- Report adverse events per IRB requirements.
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## 12. References
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- Child Sensory Profile Administration and Scoring Manual
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- Institutional Human Subjects Research Policy
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- IRB Protocol FX-ROOTS
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