measure-repository/Forms/Validation-Records/FRM-VAL-001-Validation-Study-Protocol.md

# Psychometric Validation Study Protocol

| Form ID | FRM-VAL-001 |
|---------|-------------|
| Form Title | Psychometric Validation Study Protocol |
| Version | 1.0 |
| Effective Date | [DATE] |

---

## 1. Study Identification

| Field | Information |
|-------|-------------|
| Protocol Title | |
| Protocol Number | |
| Protocol Version | |
| Protocol Date | |
| Principal Investigator | |
| Biostatistician | |
| Sponsor | |

## 2. Outcome Measure Information

| Field | Information |
|-------|-------------|
| Measure Name | |
| Measure Type | ☐ PRO  ☐ ClinRO  ☐ ObsRO  ☐ PerfO |
| Version/Form | |
| Number of Items | |
| Subscales | |
| Recall Period | |
| Response Format | |
| Copyright Status | |
| License Status | |

## 3. Background and Rationale

### 3.1 Construct Being Measured
[Describe the concept or construct the measure assesses]

________________________________________________________________
________________________________________________________________
________________________________________________________________

### 3.2 Target Population
[Define the intended respondent population]

________________________________________________________________
________________________________________________________________
________________________________________________________________

### 3.3 Intended Use
[Describe how the measure will be used - e.g., clinical trials endpoint, clinical assessment, screening tool]

________________________________________________________________
________________________________________________________________
________________________________________________________________

### 3.4 Rationale for Validation Study
[Explain why validation is needed - new measure, new population, new context, etc.]

________________________________________________________________
________________________________________________________________
________________________________________________________________

### 3.5 Existing Evidence
[Summarize any existing validation evidence]

________________________________________________________________
________________________________________________________________
________________________________________________________________

## 4. Validation Objectives

### 4.1 Primary Objectives

☐ Assess reliability
  - ☐ Internal consistency
  - ☐ Test-retest reliability
  - ☐ Inter-rater reliability

☐ Assess validity
  - ☐ Content validity
  - ☐ Construct validity (convergent/discriminant)
  - ☐ Known-groups validity
  - ☐ Criterion validity

☐ Assess responsiveness
  - ☐ Sensitivity to change
  - ☐ Minimal clinically important difference (MCID)

☐ Assess interpretability
  - ☐ Score distributions
  - ☐ Floor/ceiling effects
  - ☐ Clinical cutoffs

### 4.2 Secondary Objectives

________________________________________________________________
________________________________________________________________

## 5. Study Design

| Design Element | Description |
|----------------|-------------|
| Study Type | ☐ Cross-sectional  ☐ Longitudinal  ☐ Test-retest  ☐ Other: _____ |
| Number of Timepoints | |
| Duration of Follow-up | |
| Study Settings | |

## 6. Study Population

### 6.1 Inclusion Criteria
1. ___________________________________________________________
2. ___________________________________________________________
3. ___________________________________________________________
4. ___________________________________________________________

### 6.2 Exclusion Criteria
1. ___________________________________________________________
2. ___________________________________________________________
3. ___________________________________________________________
4. ___________________________________________________________

## 7. Sample Size

### 7.1 Reliability Analyses

| Analysis | Minimum N | Target N | Rationale |
|----------|-----------|----------|-----------|
| Internal Consistency | | | |
| Test-Retest | | | |
| Inter-Rater | | | |

### 7.2 Validity Analyses

| Analysis | Minimum N | Target N | Rationale |
|----------|-----------|----------|-----------|
| Factor Analysis | | | |
| Known-Groups | | | |
| Convergent Validity | | | |

### 7.3 Responsiveness Analyses

| Analysis | Minimum N | Target N | Rationale |
|----------|-----------|----------|-----------|
| Change Over Time | | | |
| MCID Determination | | | |

## 8. Comparison Measures

### 8.1 For Construct Validity

| Measure Name | Construct Assessed | Expected Correlation | Rationale |
|--------------|-------------------|---------------------|-----------|
| | | Convergent (r ≥ 0.50) | |
| | | Discriminant (r < 0.30) | |
| | | | |

### 8.2 For Criterion Validity

| Criterion Measure | Type | Expected Agreement | Rationale |
|------------------|------|-------------------|-----------|
| | ☐ Gold Standard  ☐ Anchor | | |

### 8.3 For Responsiveness

| Anchor Measure | Purpose | Expected Correlation | Rationale |
|----------------|---------|---------------------|-----------|
| | Patient global rating | | |
| | Clinician global rating | | |

## 9. Data Collection Schedule

| Timepoint | Window | Measures to Administer | Purpose |
|-----------|--------|------------------------|---------|
| Baseline | | | |
| | | | |
| | | | |

## 10. Administration Procedures

### 10.1 Training Requirements
________________________________________________________________
________________________________________________________________

### 10.2 Administration Mode
☐ Self-administered paper
☐ Interviewer-administered
☐ Electronic (eCOA)
☐ Other: _____________________

### 10.3 Administration Order
________________________________________________________________
________________________________________________________________

## 11. Statistical Analysis Plan

### 11.1 Reliability Analyses

#### Internal Consistency
- Cronbach's alpha (target ≥ 0.70)
- Item-total correlations
- Factor analysis (exploratory or confirmatory)

#### Test-Retest Reliability
- Intraclass correlation coefficient (target ≥ 0.70)
- Standard error of measurement
- Bland-Altman plots
- Time between assessments: __________

#### Inter-Rater Reliability (if applicable)
- ICC or weighted kappa (target ≥ 0.70)
- Percent agreement

### 11.2 Validity Analyses

#### Construct Validity
- Convergent validity: Pearson correlations (target r ≥ 0.50)
- Discriminant validity: Pearson correlations (target r < 0.30)
- Confirmatory factor analysis: CFI > 0.90, RMSEA < 0.08
- Known-groups validity: t-tests or ANOVA with effect sizes

#### Content Validity (if applicable)
- Qualitative methods
- Sample size: __________
- Analysis approach: ___________________________________

### 11.3 Responsiveness Analyses

- Effect sizes: Cohen's d, standardized response mean
- Correlation with change in anchors
- ROC analysis for MCID
- Distribution-based methods: 0.5 SD, 1 SEM

### 11.4 Interpretability Analyses

- Floor/ceiling effects (>15% at extremes)
- Score distributions (mean, SD, skewness, kurtosis)
- Clinical cutoffs (if applicable)
- Normative data (if applicable)

### 11.5 Missing Data Handling

Strategy: ___________________________________________________
____________________________________________________________

### 11.6 Software

☐ SAS        Version: __________
☐ R          Version: __________
☐ SPSS       Version: __________
☐ Mplus      Version: __________
☐ Other: ________________

## 12. Success Criteria

[Define criteria for considering the measure adequately validated]

| Measurement Property | Success Criterion |
|---------------------|------------------|
| Internal Consistency | |
| Test-Retest Reliability | |
| Construct Validity | |
| Responsiveness | |

## 13. Timeline

| Milestone | Target Date | Responsible |
|-----------|-------------|-------------|
| Protocol finalization | | |
| Ethics approval | | |
| Participant recruitment start | | |
| Baseline data collection complete | | |
| Follow-up data collection complete | | |
| Data analysis complete | | |
| Validation report draft | | |
| Validation report final | | |

## 14. Ethical Considerations

| Element | Status/Details |
|---------|----------------|
| IRB/Ethics Committee | |
| IRB Protocol Number | |
| Informed Consent | ☐ Required  ☐ Waived |
| HIPAA Authorization | ☐ Required  ☐ Not applicable |

## 15. Data Management

| Element | Specification |
|---------|--------------|
| Database System | |
| Data Entry Method | ☐ Single  ☐ Double |
| Quality Control Procedures | |
| Data Storage Location | |
| Data Retention Period | |

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## Protocol Signatures

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Principal Investigator | | | |
| Biostatistician | | | |
| Quality Manager | | | |

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**Related Documents:**
- SOP-VAL-001: Psychometric Validation of Clinical Outcome Measures
- FRM-VAL-002: Psychometric Validation Report Template
- SOP-DM-001: Data Management for Validation Studies