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

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 | "" | "" |