feat: Add SOP-LAB-002 for Vineland-3 assessment administration

Create comprehensive standard operating procedure for administering
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) to
pediatric participants with neurodevelopmental disorders.

Key sections include:
- Comprehensive training and competency requirements
- Detailed interview and rating form administration procedures
- Basal and ceiling rules for efficient assessment
- Pediatric and neurodevelopmental-specific considerations
- Quality control and data integrity measures
- Regulatory compliance (FDA 21 CFR Part 11, GCP, HIPAA)
- Deviation management and adverse event handling

Addresses Change Request #3

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

@@ -1,139 +0,0 @@
----
-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

@@ -1,100 +0,0 @@
-```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/Lab/SOP-LAB-002-Vineland-3-Assessment.md

@@ -0,0 +1,291 @@
+---
+title: "Standard Operating Procedure for Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Administration"
+author: ""
+date: 2025-12-29
+version: "1.0"
+status: "Draft"
+---
+
+## 1. Purpose
+The purpose of this Standard Operating Procedure (SOP) is to establish standardized procedures for administering the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) to pediatric participants with neurodevelopmental disorders in research settings. This SOP ensures consistency, reliability, validity, data integrity, and regulatory compliance across all study personnel.
+
+## 2. Scope
+This SOP applies to:
+- Clinical Research Coordinators (CRCs)
+- Licensed psychologists and psychometrists
+- Trained research assistants conducting Vineland-3 assessments
+- Study personnel involved in neurodevelopmental disorder research
+
+This SOP covers:
+- Pre-assessment preparation and participant screening
+- Interview format selection and administration
+- Respondent selection and informed consent
+- Data collection and scoring procedures
+- Quality control and data integrity
+- Documentation and deviation handling
+
+## 3. Regulatory and Quality References
+- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
+- FDA 21 CFR Parts 50, 56, 312 – Human Subjects Protection and Clinical Investigations
+- ICH E6(R2) Good Clinical Practice (GCP)
+- ISO 9001 – Quality Management Systems
+- Vineland-3 Manual and Technical Documentation (Pearson)
+- Study Protocol and Statistical Analysis Plan
+- Institutional Review Board (IRB) Approval Letter
+- HIPAA Privacy Rule (45 CFR Part 164)
+
+## 4. Definitions
+| Term | Definition |
+|-----|------------|
+| Vineland-3 | Vineland Adaptive Behavior Scales, Third Edition – a standardized assessment measuring adaptive behavior across four domains |
+| Adaptive Behavior | Skills needed for everyday living including communication, socialization, daily living, and motor skills |
+| Respondent | The person (typically parent/caregiver) who provides information about the participant's adaptive behavior |
+| Interview Form | Semi-structured format where the examiner asks questions directly to the respondent |
+| Parent/Caregiver Form | Self-administered questionnaire completed by the respondent |
+| Domain | Major category of adaptive behavior (Communication, Daily Living Skills, Socialization, Motor Skills) |
+| Standard Score | Normalized score with mean of 100 and standard deviation of 15 |
+| v-scale score | Domain and subdomain scores with mean of 15 and standard deviation of 3 |
+| Neurodevelopmental Disorder | Conditions affecting neurological development (e.g., autism spectrum disorder, ADHD, intellectual disability, genetic syndromes) |
+
+## 5. Roles and Responsibilities
+| Role | Responsibility |
+|-----|----------------|
+| Principal Investigator (PI) | Overall study oversight, protocol compliance, and data integrity |
+| Licensed Psychologist | Clinical supervision, quality assurance of assessments, certification of administrators |
+| Clinical Research Coordinator | Scheduling, respondent identification, consent verification, assessment administration (if trained) |
+| Trained Research Assistant | Vineland-3 administration, accurate scoring, and documentation |
+| Data Manager | Data entry verification, database integrity, and audit compliance |
+| Quality Assurance | SOP compliance monitoring and CAPA implementation |
+
+## 6. Required Training and Competency
+All personnel administering the Vineland-3 must complete:
+- Current GCP training certification
+- Vineland-3 administration training (minimum 4 hours) including:
+  - Review of Vineland-3 manual and technical documentation
+  - Understanding of adaptive behavior constructs
+  - Practice administrations with supervision
+  - Competency verification (minimum 3 supervised administrations with 95% scoring accuracy)
+- Study-specific protocol training
+- Training on this SOP with documented acknowledgment
+- HIPAA and human subjects protection training
+
+*Training records and competency documentation must be maintained in the study regulatory binder and personnel files.*
+
+## 7. Materials and Equipment
+- Vineland-3 Interview Form protocol booklets (age-appropriate)
+- Vineland-3 Parent/Caregiver Rating Form (if applicable)
+- Vineland-3 Scoring and Reporting Software (Q-global or equivalent)
+- Secure computer with appropriate licenses and network access
+- Participant study folder with protocol-specific forms
+- Informed consent and assent documentation
+- Private, quiet assessment room
+- Age-appropriate comfort items (toys, snacks as permitted by protocol)
+- Study-specific case report forms (CRFs)
+
+## 8. Pre-Assessment Procedures
+
+### 8.1 Participant Eligibility Verification
+- Confirm participant enrollment and eligibility per study protocol
+- Verify informed consent and assent (if applicable) is current and complete
+- Confirm inclusion/exclusion criteria including neurodevelopmental disorder diagnosis
+- Review participant demographics and relevant medical/developmental history
+
+### 8.2 Respondent Selection
+The Vineland-3 respondent must:
+- Be the parent, primary caregiver, or individual with extensive knowledge of the participant's daily functioning
+- Have regular contact with the participant (minimum 4-6 hours per day or equivalent)
+- Be able to provide informed responses in English or approved translated version
+- Provide consent for participation in the assessment process
+
+**Documentation Required**: Record respondent name, relationship to participant, and frequency of contact in study records.
+
+### 8.3 Scheduling and Environment Preparation
+- Schedule assessment at a time convenient for respondent (typically 30-60 minutes)
+- Ensure private, quiet room free from distractions
+- Prepare all materials and verify software access before respondent arrival
+- Review participant's protocol schedule to coordinate with other study visits
+- Confirm respondent understanding of assessment purpose and process
+
+### 8.4 Form Selection
+Select appropriate Vineland-3 form based on:
+- **Interview Form** (Comprehensive or Brief): Recommended for standardization, rapport building, and when detailed clinical information is needed
+- **Parent/Caregiver Rating Form**: Acceptable when interview format is not feasible; requires literate respondent
+- **Age Range**: Birth through 90 years (use age-appropriate norms)
+- **Protocol Requirements**: Follow study-specific form designation if specified
+
+## 9. Vineland-3 Administration Procedures
+
+### 9.1 General Assessment Guidelines
+- Create a comfortable, non-judgmental atmosphere
+- Explain that assessment measures typical performance, not maximum capability
+- Emphasize there are no "right" or "wrong" answers
+- Clarify that assessment focuses on what the child **usually does**, not what they **can do**
+- Maintain professional boundaries and avoid providing clinical feedback during administration
+
+### 9.2 Interview Form Administration (Step-by-Step)
+
+#### Starting the Interview
+1. Greet respondent and verify participant identity using two identifiers
+2. Review informed consent and confirm respondent's voluntary participation
+3. Explain assessment purpose: "This questionnaire helps us understand [participant's name]'s everyday skills in areas like communication, daily living, socializing, and movement."
+4. Establish rapport and clarify confidentiality protections
+5. Record assessment start time
+
+#### Conducting the Interview
+1. **Follow Standardized Script**: Use questions as written in the Interview Form manual
+2. **Score Response in Real-Time**:
+   - **2 = Yes, usually**: Performs activity habitually without reminders
+   - **1 = Sometimes or partially**: Emerging skill or requires assistance
+   - **0 = No, never**: Does not perform activity
+   - **DK = Don't Know**: Respondent lacks sufficient information
+   - **N/O = No Opportunity**: Participant has not had chance to perform activity
+3. **Probe When Necessary**: If response is unclear, ask neutral follow-up questions (e.g., "Can you give me an example of how [name] does this?")
+4. **Maintain Engagement**: Acknowledge respondent input, remain neutral, avoid leading questions
+5. **Observe for Respondent Fatigue**: Offer breaks if needed, especially with comprehensive form
+
+#### Completing the Interview
+1. Administer all required items per basal/ceiling rules (see Section 9.4)
+2. Review for any skipped or ambiguous items
+3. Thank respondent for their time and participation
+4. Record assessment completion time
+5. Do **not** provide preliminary scores or clinical interpretations to respondent
+
+### 9.3 Parent/Caregiver Rating Form Administration
+If using the self-administered form:
+1. Provide respondent with form and clear instructions
+2. Remain available to answer procedural questions without influencing responses
+3. Ensure private space for completion
+4. Review completed form for missing or double-marked items before respondent leaves
+5. Collect form and verify all sections are complete
+
+### 9.4 Basal and Ceiling Rules (Interview Form)
+To ensure efficient and valid administration:
+
+**Basal Rule**:
+- Establish a basal by obtaining **7 consecutive scores of 2**
+- If basal is not achieved, continue backward until 7 consecutive 2s are obtained
+- Items below basal are assumed to be scored as 2
+
+**Ceiling Rule**:
+- Discontinue subdomain when **7 consecutive scores of 0** are obtained
+- Items above ceiling are assumed to be scored as 0
+
+**Note**: Some subdomains (e.g., Motor Skills for older children) may have abbreviated ranges. Follow manual guidelines for age-specific starting points.
+
+### 9.5 Pediatric and Neurodevelopmental Considerations
+When assessing children with neurodevelopmental disorders:
+- **Use Concrete Examples**: Some respondents may need help understanding items; provide neutral examples without suggesting answers
+- **Consider Adaptive Equipment**: Score based on how the child performs the activity, even with assistive devices (e.g., communication device for verbal communication items)
+- **Account for Behavioral Variability**: If behavior fluctuates significantly, ask respondent to consider typical frequency over the past month
+- **Cultural Sensitivity**: Be aware of cultural differences in expectations for adaptive behavior (e.g., self-care, socialization norms)
+- **Document Unique Circumstances**: Note in study records if participant has unusual living situation or support that affects adaptive behavior assessment
+
+## 10. Scoring and Data Entry
+
+### 10.1 Scoring Procedures
+- Score assessment immediately after administration while details are fresh
+- Use Vineland-3 Scoring Software (Q-global or equivalent) per licensing agreement
+- Enter all item responses accurately
+- Verify that software calculates:
+  - Subdomain v-scale scores
+  - Domain standard scores
+  - Adaptive Behavior Composite (ABC) score
+  - Percentile ranks and age equivalents (if required by protocol)
+- **Double-Check Entry**: Review for data entry errors before finalizing
+
+### 10.2 Quality Control
+- **Independent Review**: Have a second trained team member verify scoring accuracy for first 10 assessments and randomly thereafter (minimum 10% of all assessments)
+- **Reconcile Discrepancies**: Resolve scoring differences through consensus review; escalate to licensed psychologist if needed
+- **Flag Unusual Patterns**:
+  - Excessive "DK" or "N/O" responses (may indicate inadequate respondent)
+  - Inconsistent item patterns within subdomains
+  - Scores significantly discrepant from other clinical data
+- Document quality control reviews in study files
+
+### 10.3 Data Entry into Study Database
+- Transfer scores to electronic Case Report Form (eCRF) per protocol schedule
+- Ensure compliance with FDA 21 CFR Part 11 for electronic data:
+  - Use unique user credentials (no shared logins)
+  - Document audit trail for all entries and changes
+  - Maintain data backup and security protocols
+- Enter only de-identified data per HIPAA requirements
+- Verify data accuracy before database lock
+
+## 11. Documentation Requirements
+All assessments must include documentation of:
+- Date and time of assessment
+- Respondent name and relationship to participant
+- Form type and version used (Interview or Parent/Caregiver)
+- Raw scores, v-scale scores, standard scores, and ABC
+- Any deviations from standard administration (see Section 12)
+- Administrator name and signature
+- Quality control review (if performed)
+- Adverse events or participant distress (if applicable)
+
+**Storage**: Maintain source documentation in participant study binder. Electronic scores in secure database with access controls.
+
+## 12. Deviations and Noncompliance
+
+### 12.1 Common Deviations
+Examples of protocol deviations include:
+- Using unqualified or inadequately trained respondent
+- Administering assessment outside protocol-specified visit window
+- Incomplete assessment (e.g., respondent unable to complete interview)
+- Software malfunction or scoring errors
+- Loss of data due to technical issues
+
+### 12.2 Deviation Management
+- **Document Immediately**: Record deviation in study deviation log and source documents
+- **Notify PI**: Report deviation per study procedures (typically within 24-48 hours)
+- **Assess Impact**: Determine if deviation affects data validity or participant safety
+- **Implement Corrective Action**: Retrain personnel, revise procedures, or exclude data as appropriate
+- **Submit Reports**: Follow institutional and sponsor requirements for deviation reporting
+
+### 12.3 Handling Incomplete Assessments
+If assessment cannot be completed:
+- Document reason (e.g., respondent time constraints, participant distress, technical issue)
+- Attempt to reschedule if within protocol visit window
+- Consult PI regarding data handling (e.g., partial data use, exclusion from analysis)
+- Do not impute or estimate missing responses
+
+## 13. Adverse Events and Participant Welfare
+
+### 13.1 Potential Assessment-Related Issues
+While rare, be prepared for:
+- **Respondent Emotional Distress**: Questions about child's limitations may be upsetting; offer breaks, provide supportive (non-clinical) listening, refer to PI if needed
+- **Disclosure of Safety Concerns**: If respondent reveals abuse, neglect, or imminent harm, follow mandatory reporting laws and study safety protocols
+- **Participant Behavioral Issues**: If child becomes distressed during assessment, pause or discontinue; notify PI
+
+### 13.2 Documentation and Reporting
+- Document any adverse event or safety concern in study safety database
+- Notify PI immediately for any serious concerns
+- Maintain participant confidentiality per HIPAA while ensuring safety
+
+## 14. Data Security and Confidentiality
+- Store all paper Vineland-3 forms in locked, limited-access cabinets
+- Maintain electronic data on password-protected, encrypted systems
+- Use only study-assigned participant IDs (no PHI in assessment records)
+- Dispose of outdated or superseded records per institutional data retention policy
+- Limit access to assessment data to authorized study personnel only
+
+## 15. Quality Control and Auditing
+- **Inter-Rater Reliability**: Conduct periodic reliability assessments between administrators (target ≥90% agreement)
+- **Periodic Record Review**: Quality Assurance team reviews random sample of assessments quarterly
+- **Corrective and Preventive Actions (CAPA)**: Implement when systematic issues are identified
+- **Audit Readiness**: Maintain organized, complete documentation for regulatory inspections
+
+## 16. Revision History and Change Management
+All changes to this SOP must follow document control procedures per organizational SOP-001 (or equivalent). Superseded versions must be archived with documented rationale for changes.
+
+## Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2025-12-29 | Initial Draft | "" |
+
+## Approval Signatures
+| Name | Title | Signature | Date |
+|-----|-------|-----------|------|
+| "" | Principal Investigator | "" | "" |
+| "" | Licensed Psychologist | "" | "" |
+| "" | Quality Assurance | "" | "" |
+| "" | Study Sponsor Representative | "" | "" |

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

@@ -1,111 +0,0 @@
----
-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

@@ -1,94 +0,0 @@
----
-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.
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-## 7. Materials and Equipment
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-- 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
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-## 8. Procedure
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-### 8.1 Pre-Administration
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-- 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.
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-### 8.2 Administration
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-- 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.
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-### 8.3 Post-Administration
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-- 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.
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-## 9. Data Management and Confidentiality
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-- 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.
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-## 10. Quality Assurance and Deviations
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-- 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.
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-## 11. Safety and Ethical Considerations
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-- 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.
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-## 12. References
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-- Child Sensory Profile Administration and Scoring Manual
-- Institutional Human Subjects Research Policy
-- IRB Protocol FX-ROOTS
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