Create sop: Standard Operating Procedure for Administering the Child Sensory Profile

SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md

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+---
+title: "Standard Operating Procedure for Administering the Child Sensory Profile"
+author: ""
+date: 2026-01-05
+version: "1.0"
+status: "Draft"
+---
+
+## 1. Purpose
+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.
+
+## 2. Scope
+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.
+
+## 3. Regulatory and Institutional Compliance
+This SOP is designed to comply with the following:
+- Institutional policies governing human subjects research
+- IRB-approved protocol FX-ROOTS
+- ISO 9001: Quality Management Systems principles
+- ISO 13485: Documentation and data integrity best practices
+- FDA 21 CFR Part 11 principles where electronic records or signatures are used, if applicable
+
+*If certain regulations are not applicable, document justification per institutional policy.*
+
+## 4. Definitions and Abbreviations
+| Term | Definition |
+|-----|------------|
+| Child Sensory Profile | A standardized caregiver-reported assessment evaluating a child’s sensory processing patterns |
+| CSP | Child Sensory Profile |
+| IRB | Institutional Review Board |
+
+## 5. Roles and Responsibilities
+| Role | Responsibilities |
+|-----|------------------|
+| Research Staff | Administer CSP, ensure protocol compliance, maintain data confidentiality |
+| Students | Administer CSP under supervision, complete required training, follow this SOP |
+| Principal Investigator | Oversight of SOP adherence and IRB compliance |
+
+## 6. Authorization and Training
+- Only authorized research_staff and students may administer the CSP.
+- Personnel must complete required human subjects research and protocol-specific training prior to administration.
+- Training records must be maintained according to institutional policy.
+
+## 7. Materials and Equipment
+- Authorized version of the Child Sensory Profile (paper or electronic)
+- Participant information sheet and consent documentation
+- Data collection tools (e.g., secure database, scoring software)
+- Secure storage system for completed assessments
+
+## 8. Procedure
+
+### 8.1 Pre-Administration
+- Verify IRB approval and participant eligibility.
+- Confirm informed consent has been obtained and documented.
+- Assign a unique participant identifier.
+- Prepare CSP materials and ensure a quiet, distraction-free environment.
+
+### 8.2 Administration
+- Provide standardized instructions to the caregiver as outlined in the CSP manual.
+- Answer procedural questions without influencing responses.
+- Ensure the caregiver completes all required items.
+- Monitor for incomplete or inconsistent responses.
+
+### 8.3 Post-Administration
+- Review the CSP for completeness.
+- Score the assessment according to the official scoring guidelines.
+- Document administration date, administrator name, and any deviations.
+- Address missing data per protocol guidance.
+
+## 9. Data Management and Confidentiality
+- Store completed assessments in secure, access-controlled systems.
+- Electronic records must follow institutional data security requirements.
+- De-identify data prior to analysis when required.
+- Retain records according to IRB and institutional retention schedules.
+
+## 10. Quality Assurance and Deviations
+- Periodic audits may be conducted to ensure SOP adherence.
+- Deviations must be documented and reported to the Principal Investigator.
+- Corrective actions should be implemented as needed.
+
+## 11. Safety and Ethical Considerations
+- Respect participant privacy and confidentiality at all times.
+- Discontinue administration if participant distress is observed and follow protocol guidance.
+- Report adverse events per IRB requirements.
+
+## 12. References
+- Child Sensory Profile Administration and Scoring Manual
+- Institutional Human Subjects Research Policy
+- IRB Protocol FX-ROOTS
+
+## 13. Revision History
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2026-01-05 | Initial draft | "" |
+
+## 14. Approval Signatures
+| Name | Title | Signature | Date |
+|-----|-------|-----------|------|
+| "" | Principal Investigator | "" | "" |
+| "" | Quality/Compliance Reviewer | "" | "" |