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