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

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Ernie Pedapati
2026-01-05 11:18:36 -05:00
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SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md
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@@ -5,43 +5,39 @@ date: 2026-01-05
version: "1.0" version: "1.0"
status: "Draft" status: "Draft"
--- ---
## 1. Purpose ## 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. 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 ## 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. 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 ## 3. Regulatory and Institutional Compliance
This SOP is designed to comply with the following: This SOP is designed to comply with the following:
- Institutional policies governing human subjects research - Institutional policies governing human subjects research
- IRB-approved protocol FX-ROOTS - 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.* *If certain regulations are not applicable, document justification per institutional policy.*
## 4. Definitions and Abbreviations ## 4. Definitions and Abbreviations
| Term | Definition |
|-----|------------| TermDefinitionChild Sensory ProfileA standardized caregiver-reported assessment evaluating a child’s sensory processing patternsCSPChild Sensory ProfileIRBInstitutional Review Board
| 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 ## 5. Roles and Responsibilities
| Role | Responsibilities |
|-----|------------------| 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
| 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 ## 6. Authorization and Training
- Only authorized research_staff and students may administer the CSP. - Only authorized research_staff and students may administer the CSP.
- Personnel must complete required human subjects research and protocol-specific training prior to administration. - Personnel must complete required human subjects research and protocol-specific training prior to administration.
- Training records must be maintained according to institutional policy. - Training records must be maintained according to institutional policy.
## 7. Materials and Equipment ## 7. Materials and Equipment
- Authorized version of the Child Sensory Profile (paper or electronic) - Authorized version of the Child Sensory Profile (paper or electronic)
- Participant information sheet and consent documentation - Participant information sheet and consent documentation
- Data collection tools (e.g., secure database, scoring software) - Data collection tools (e.g., secure database, scoring software)
@@ -50,51 +46,49 @@ This SOP is designed to comply with the following:
## 8. Procedure ## 8. Procedure
### 8.1 Pre-Administration ### 8.1 Pre-Administration
- Verify IRB approval and participant eligibility. - Verify IRB approval and participant eligibility.
- Confirm informed consent has been obtained and documented. - Confirm informed consent has been obtained and documented.
- Assign a unique participant identifier. - Assign a unique participant identifier.
- Prepare CSP materials and ensure a quiet, distraction-free environment. - Prepare CSP materials and ensure a quiet, distraction-free environment.
### 8.2 Administration ### 8.2 Administration
- Provide standardized instructions to the caregiver as outlined in the CSP manual. - Provide standardized instructions to the caregiver as outlined in the CSP manual.
- Answer procedural questions without influencing responses. - Answer procedural questions without influencing responses.
- Ensure the caregiver completes all required items. - Ensure the caregiver completes all required items.
- Monitor for incomplete or inconsistent responses. - Monitor for incomplete or inconsistent responses.
### 8.3 Post-Administration ### 8.3 Post-Administration
- Review the CSP for completeness. - Review the CSP for completeness.
- Score the assessment according to the official scoring guidelines. - Score the assessment according to the official scoring guidelines.
- Document administration date, administrator name, and any deviations. - Document administration date, administrator name, and any deviations.
- Address missing data per protocol guidance. - Address missing data per protocol guidance.
## 9. Data Management and Confidentiality ## 9. Data Management and Confidentiality
- Store completed assessments in secure, access-controlled systems. - Store completed assessments in secure, access-controlled systems.
- Electronic records must follow institutional data security requirements. - Electronic records must follow institutional data security requirements.
- De-identify data prior to analysis when required. - De-identify data prior to analysis when required.
- Retain records according to IRB and institutional retention schedules. - Retain records according to IRB and institutional retention schedules.
## 10. Quality Assurance and Deviations ## 10. Quality Assurance and Deviations
- Periodic audits may be conducted to ensure SOP adherence. - Periodic audits may be conducted to ensure SOP adherence.
- Deviations must be documented and reported to the Principal Investigator. - Deviations must be documented and reported to the Principal Investigator.
- Corrective actions should be implemented as needed. - Corrective actions should be implemented as needed.
## 11. Safety and Ethical Considerations ## 11. Safety and Ethical Considerations
- Respect participant privacy and confidentiality at all times. - Respect participant privacy and confidentiality at all times.
- Discontinue administration if participant distress is observed and follow protocol guidance. - Discontinue administration if participant distress is observed and follow protocol guidance.
- Report adverse events per IRB requirements. - Report adverse events per IRB requirements.
## 12. References ## 12. References
- Child Sensory Profile Administration and Scoring Manual - Child Sensory Profile Administration and Scoring Manual
- Institutional Human Subjects Research Policy - Institutional Human Subjects Research Policy
- IRB Protocol FX-ROOTS - 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 | "" | "" |