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

title, author, date, version, status

title	author	date	version	status
Standard Operating Procedure for Administering the Child Sensory Profile		2026-01-05	1.0	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	""	""