---
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 | "" | "" |