From e1fe456d082769c88ee05cc83657528581f77162 Mon Sep 17 00:00:00 2001 From: Ernie Pedapati Date: Mon, 5 Jan 2026 11:18:36 -0500 Subject: [PATCH] Update SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md --- ...001-Administering-Child-Sensory-Profile.md | 42 ++++++++----------- 1 file changed, 18 insertions(+), 24 deletions(-) diff --git a/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md b/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md index aee1944..a0c871c 100644 --- a/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md +++ b/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md @@ -5,43 +5,39 @@ 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 | + +TermDefinitionChild Sensory ProfileA standardized caregiver-reported assessment evaluating a child’s sensory processing patternsCSPChild Sensory ProfileIRBInstitutional 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 | + +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 ## 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) @@ -50,51 +46,49 @@ This SOP is designed to comply with the following: ## 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 | "" | "" | \ No newline at end of file +## \ No newline at end of file