From f492241ebc8d522c1366d5ccedf6a97fd19db5bc Mon Sep 17 00:00:00 2001 From: Ernie Pedapati Date: Mon, 5 Jan 2026 11:17:51 -0500 Subject: [PATCH] Create sop: Standard Operating Procedure for Administering the Child Sensory Profile --- ...001-Administering-Child-Sensory-Profile.md | 100 ++++++++++++++++++ 1 file changed, 100 insertions(+) create mode 100644 SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md diff --git a/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md b/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md new file mode 100644 index 0000000..aee1944 --- /dev/null +++ b/SOPs/SOP-LAB-001-Administering-Child-Sensory-Profile.md @@ -0,0 +1,100 @@ +--- +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 | "" | "" | \ No newline at end of file