Update SOPs/SOP-IT-001-Vision-Based-AI-Form-Filling-for-Prior-Authorizations.md

Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md

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+---
+title: "Standard Operating Procedure for Handling Broken EEG Nets"
+author: ""
+date: 2026-01-05
+version: "1.0"
+status: "Draft"
+---
+## 1. Purpose
+
+- Define standardized procedures for identifying, handling, documenting, repairing, or disposing of broken EEG nets.
+- Ensure compliance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485 requirements.
+- Minimize risk to subjects, staff, and data integrity.
+
+## 2. Scope
+
+- Applies to all EEG nets used in clinical, research, or manufacturing environments within the organization.
+- Covers detection of damage, removal from service, evaluation, repair, disposal, and documentation.
+
+## 3. Definitions
+
+- **EEG Net**: A multi-electrode sensor array used for electroencephalography data collection.
+- **Broken EEG Net**: Any EEG net exhibiting physical damage, electrical malfunction, missing components, or performance deviation.
+- **Nonconformance**: Failure to meet specified requirements.
+
+## 4. Regulatory and Quality References
+
+- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
+- ISO 9001 – Quality Management Systems
+- ISO 13485 – Medical Devices Quality Management Systems
+- Internal Quality Manual ""
+- Risk Management Procedure ""
+
+## 5. Responsibilities
+
+- **EEG Technician**
+  - Identify and report broken EEG nets.
+  - Remove affected nets from service immediately.
+- **Quality Assurance (QA)**
+  - Review documentation and assess compliance.
+  - Approve repair or disposal decisions.
+- **Engineering / Maintenance**
+  - Evaluate damage and perform authorized repairs.
+- **Document Control**
+  - Maintain records in accordance with Part 11 requirements.
+
+## 6. Required Materials and Records
+
+- Nonconformance Report (NCR) Form ""
+- Equipment Log ""
+- Repair and Maintenance Record ""
+- Labeling materials for status identification
+
+## 7. Procedure
+
+### 7.1 Identification of Broken EEG Nets
+
+- Inspect EEG nets before and after each use.
+- Indicators of breakage include:
+  - Visible tears or frayed wiring
+  - Missing or damaged electrodes
+  - Signal noise or failure during testing
+- *Document findings immediately upon detection.*
+
+### 7.2 Removal from Service
+
+- Tag the EEG net as "Out of Service".
+- Remove from clinical or research area.
+- Update the Equipment Log with date and reason.
+
+### 7.3 Documentation
+
+- Complete a Nonconformance Report with:
+  - Net identification number ""
+  - Description of damage ""
+  - Date identified ""
+  - Reporter name ""
+- Ensure electronic records comply with 21 CFR Part 11 controls.
+
+### 7.4 Evaluation and Disposition
+
+- QA and Engineering assess:
+  - Severity of damage
+  - Impact on data integrity and safety
+- Determine disposition:
+  - Repair
+  - Return to vendor
+  - Disposal
+- *Record justification for the decision.*
+
+### 7.5 Repair Process
+
+- Perform repairs only by trained and authorized personnel.
+- Verify functionality post-repair using approved testing methods.
+- Document all repair activities and results.
+
+### 7.6 Disposal
+
+- Dispose of irreparable EEG nets according to waste management and environmental procedures.
+- Remove asset from inventory records.
+
+### 7.7 Return to Service
+
+- QA approval required prior to reuse.
+- Update status label to "Approved for Use".
+- Archive all related records.
+
+## 8. Training Requirements
+
+- Personnel must be trained on this SOP prior to handling EEG nets.
+- Training records shall be maintained and reviewed periodically.
+
+## 9. Risk Management
+
+- Identify risks associated with use of damaged EEG nets.
+- Implement controls to prevent recurrence.
+- Link nonconformance data to corrective and preventive action processes.
+
+## 10. Deviations and Corrective Actions
+
+- Document any deviations from this SOP.
+- Initiate CAPA when trends or repeated failures are identified.
+
+## 11. Records Retention
+
+- Retain records according to Records Retention Policy "".
+- Ensure secure storage and controlled access.
+
+## 12. Change Management
+
+- Changes to this SOP require review and approval per Document Control procedures.
+- Maintain revision history.
+
+## 13. Version Control
+
+VersionDateDescription of ChangeAuthor1.02026-01-05Initial draft""
+
+## 14. Approval Signatures
+
+NameTitleSignatureDate""""""""""""""""""""""""

SOPs/LAB/SOP-LAB-001-calming-distressed-toddler-eye-tracking.md

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+```yaml
+---
+title: "Procedure for Calming a Distressed Toddler During Eye-Tracking Assessments"
+author: ""
+date: 2026-01-02
+version: "1.0"
+status: "Draft"
+---
+```
+
+## 1. Purpose
+This Standard Operating Procedure (SOP) defines a standardized, ethical, and child-centered approach for calming a distressed toddler during eye-tracking assessments conducted at PNRL. The purpose is to ensure participant safety, data integrity, and compliance with Institutional Review Board (IRB) requirements.
+
+## 2. Scope
+This SOP applies to all eye-tracking assessment sessions involving toddlers conducted by PNRL research staff. It is intended for use before, during, and immediately after assessment activities when a toddler shows signs of distress.
+
+## 3. Audience
+- Research Assistants
+- Study Coordinators
+- Principal Investigator (oversight)
+
+## 4. Regulatory and Ethical Compliance
+This SOP is designed to comply with:
+- Institutional Review Board (IRB)–approved study protocols
+- Ethical principles for research involving children
+- ISO 9001 Quality Management Systems (documentation and process control)
+- ISO 13485 principles where applicable to research devices
+- FDA 21 CFR Part 11 (where electronic records or signatures are used)
+
+## 5. Definitions
+| Term | Definition |
+|------|------------|
+| Toddler | A child typically aged 12–36 months |
+| Distress | Observable signs of discomfort, fear, crying, refusal, or agitation |
+| Eye-Tracking Assessment | A non-invasive procedure measuring visual attention using eye-tracking equipment |
+
+## 6. Roles and Responsibilities
+| Role | Responsibility |
+|-----|----------------|
+| Research Assistant | Implement calming procedures, monitor child welfare, document events |
+| Study Coordinator | Ensure staff training and SOP adherence |
+| Principal Investigator | Ensure IRB compliance and approve deviations |
+
+## 7. Procedure
+*Follow the steps sequentially. Progress to the next step only if the toddler remains distressed.*
+
+### Step 1: Pause the Assessment
+- Immediately stop the eye-tracking task.
+- Lower or turn away visual stimuli and dim screens if applicable.
+- *Ensure the toddler is not restrained and has freedom of movement.*
+
+### Step 2: Assess the Source of Distress
+- Observe verbal and non-verbal cues (crying, pushing away equipment).
+- Ask the caregiver about possible causes (fatigue, hunger, fear).
+- *Document observations after the session.*
+
+### Step 3: Provide Comfort and Familiarization
+- Allow the caregiver to hold or comfort the toddler.
+- Use a calm voice and neutral facial expressions.
+- Introduce familiar or approved comfort items if allowed by IRB protocol.
+
+### Step 4: Offer a Brief Break or Distraction
+- Provide a short break away from the equipment.
+- Use age-appropriate, IRB-approved toys or songs.
+- *Do not coerce or pressure the toddler to continue.*
+
+### Step 5: Decide to Resume or Terminate the Session
+- Resume only if the toddler appears calm and willing.
+- If distress persists, terminate the session respectfully.
+- Thank the caregiver and toddler for participation.
+
+## 8. Documentation Requirements
+- Record occurrence of distress in the study log.
+- Note actions taken and outcome.
+- Ensure records are stored in accordance with IRB and data protection requirements.
+
+## 9. Training Requirements
+- All research assistants must be trained on this SOP prior to conducting assessments.
+- Training completion must be documented.
+
+## 10. Deviations
+- Any deviation from this SOP must be documented and reported to the Study Coordinator.
+- Significant deviations may require IRB notification per protocol.
+
+## 11. References
+- IRB-approved study protocol ""
+- Ethical Principles for Research with Human Subjects
+- ISO 9001: Quality Management Systems
+- FDA 21 CFR Part 11 (if applicable)
+
+## 12. Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2026-01-02 | Initial draft | "" |
+
+## 13. Approval Signatures
+| Name | Role | Signature | Date |
+|-----|------|-----------|------|
+| "" | Principal Investigator | "" | "" |
+| "" | Quality/Compliance | "" | "" |

SOPs/SOP-IT-001-Vision-Based-AI-Form-Filling-for-Prior-Authorizations.md

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+---
+title: "Standard Operating Procedure for Vision-Based AI Form Filling in Prior Authorizations"
+author: ""
+date: 2026-01-20
+version: "1.0"
+status: "Draft"
+---
+## 1. Purpose
+
+This Standard Operating Procedure (SOP) defines the standardized process for using vision-based artificial intelligence (AI) systems to perform form filling for prior authorization submissions. The purpose is to ensure accuracy, data integrity, regulatory compliance, and consistent operational performance in accordance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485 requirements.
+
+## 2. Scope
+
+This SOP applies to all activities related to the use, validation, operation, monitoring, and maintenance of vision-based AI technologies used to extract, interpret, and populate prior authorization forms.
+
+*Specify departments, systems, and workflows covered by this SOP.*
+
+## 3. Audience
+
+The primary audience responsible for following this SOP includes:
+
+- Clinical Staff
+- Compliance Personnel
+
+## 4. Definitions
+
+TermDefinitionVision-Based AIArtificial intelligence systems that use optical character recognition and computer vision to interpret visual dataPrior AuthorizationA requirement from a payer for approval before specific healthcare services are providedData IntegrityAssurance that data is accurate, complete, and maintained throughout its lifecycle
+
+## 5. Regulatory and Quality References
+
+Regulation / StandardDescriptionFDA 21 CFR Part 11Electronic Records and Electronic SignaturesISO 9001Quality Management Systems – RequirementsISO 13485Medical Devices – Quality Management SystemsHIPAAHealth Insurance Portability and Accountability Act
+
+## 6. Roles and Responsibilities
+
+RoleResponsibilityClinical StaffReview AI-populated forms for clinical accuracyComplianceEnsure adherence to regulatory and quality requirementsIT / AI System OwnerMaintain system availability, security, and performanceQuality AssuranceOversight of validation, audits, and continuous improvement
+
+## 7. Procedure
+
+### 7.1 System Access and Security
+
+- Ensure user access is role-based and authorized
+- Maintain audit trails in compliance with 21 CFR Part 11
+- Verify electronic signatures where applicable
+
+### 7.2 Input Document Handling
+
+- Confirm source documents are complete and legible
+- Validate document version and payer requirements
+- Upload documents according to defined workflow
+
+### 7.3 AI Form Filling Process
+
+- Initiate vision-based AI processing
+- Monitor AI extraction and field population
+- Flag low-confidence fields for manual review
+
+### 7.4 Human Review and Verification
+
+- Clinical Staff must review all AI-populated data
+- Correct errors identified during review
+- Document verification completion
+
+### 7.5 Submission and Record Retention
+
+- Submit completed prior authorization forms per payer guidelines
+- Archive records in validated electronic systems
+- Retain records according to organizational retention policy
+
+## 8. Validation and Change Management
+
+- Validate AI systems prior to production use
+- Document model updates, retraining, and configuration changes
+- Perform revalidation following significant changes
+
+*Describe validation protocol references and change control procedures.*
+
+## 9. Risk Management
+
+- Identify risks related to incorrect data extraction
+- Implement mitigation controls and monitoring
+- Review incidents and corrective actions
+
+## 10. Training Requirements
+
+- All users must complete initial and periodic training
+- Training records must be maintained
+- Competency assessments should be documented
+
+## 11. Monitoring, Auditing, and Continuous Improvement
+
+- Conduct periodic audits of AI performance and compliance
+- Track key performance indicators and error rates
+- Implement corrective and preventive actions as needed
+
+## 12. Documentation and Records
+
+Record TypeStorage LocationRetention PeriodAI Output Logs""""Audit Trails""""Training Records""""
+
+## 13. Deviations
+
+- Document any deviations from this SOP
+- Assess impact and implement corrective actions
+- Obtain approval for deviation closure
+
+## 14. Version Control
+
+VersionDateDescription of ChangeAuthor1.02026-01-20Initial draft""
+
+## 15. Approval Signatures
+
+NameTitleSignatureDate""""""""""""""""

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

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+---
+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
+
+*If certain regulations are not applicable, document justification per institutional policy.*
+
+## 4. Definitions and Abbreviations
+
+TermDefinitionChild Sensory ProfileA standardized caregiver-reported assessment evaluating a child’s sensory processing patternsCSPChild Sensory ProfileIRBInstitutional Review Board
+
+## 5. Roles and 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
+
+## 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
+
+##