Sync template from atomicqms-style deployment

Forms/License-Tracking/FRM-LIC-001-License-Requirements-Checklist.md

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+# License Requirements Checklist
+
+| Form ID | FRM-LIC-001 |
+|---------|-------------|
+| Form Title | License Requirements Checklist |
+| Version | 1.0 |
+| Effective Date | [DATE] |
+
+---
+
+## Measure Information
+
+| Field | Information |
+|-------|-------------|
+| Measure Name | |
+| Version/Form | |
+| Measure Type | ☐ PRO  ☐ ClinRO  ☐ ObsRO  ☐ PerfO |
+| Purpose/Study | |
+| Protocol Number | |
+
+## Copyright Status
+
+| Field | Response |
+|-------|----------|
+| Copyright Holder | |
+| Copyright Holder Contact | |
+| Website | |
+
+### Copyright Classification
+
+☐ **Public Domain**
+- No copyright restrictions
+- Free to use without permission
+- No license required
+
+☐ **Open Access with Attribution**
+- Free to use
+- Attribution required
+- Specific citation format: _____________________
+
+☐ **Proprietary - License Required**
+- Paid license required
+- License type needed: ☐ Academic  ☐ Commercial  ☐ Clinical
+- Proceed to License Requirements section
+
+☐ **Special Permission Required**
+- Must contact copyright holder for permission
+- Restrictions on use: _____________________
+
+## License Requirements (if applicable)
+
+### License Type Options
+
+| License Type | Cost | Terms | Notes |
+|--------------|------|-------|-------|
+| Single Study | | | |
+| Multi-Study | | | |
+| Institutional | | | |
+| Commercial | | | |
+
+### Scope of Use
+
+Number of Participants: _________
+
+Study Sites/Locations: _________________________________________
+
+Countries: ___________________________________________________
+
+Study Duration: From __________ to __________
+
+### Administration Mode
+
+☐ Paper-based
+☐ Electronic (eCOA)
+  - Platform: _____________________
+  - Additional fees for electronic use? ☐ Yes  ☐ No
+
+### Translation Requirements
+
+Languages needed: _____________________________________________
+
+☐ Official translations available
+☐ New translation required (see SOP-TRN-001)
+☐ Translation included in license
+☐ Translation requires additional fee
+
+### Special Requirements/Restrictions
+
+☐ Training/certification required for administrators
+☐ Restrictions on modifications
+☐ Requirements for result reporting to copyright holder
+☐ Publication acknowledgment required
+☐ Royalty fees for commercial use
+
+Details: ________________________________________________________
+________________________________________________________________
+________________________________________________________________
+
+## Action Items
+
+| Action | Responsible | Target Date | Status |
+|--------|-------------|-------------|--------|
+| Contact copyright holder | | | |
+| Obtain license application | | | |
+| Complete application | | | |
+| Legal review | | | |
+| Obtain approval signatures | | | |
+| Submit payment | | | |
+| File executed license | | | |
+
+## Documentation Checklist
+
+☐ Copyright holder contact information verified
+☐ License application obtained
+☐ License terms reviewed
+☐ Legal review completed (if required)
+☐ Budget approved for license fees
+☐ License application submitted
+☐ License agreement received and executed
+☐ Payment processed
+☐ License filed in License Tracking Database (FRM-LIC-002)
+☐ Project team notified of license status
+
+## Notes/Additional Information
+
+________________________________________________________________
+________________________________________________________________
+________________________________________________________________
+________________________________________________________________
+
+---
+
+## Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Completed By | | | |
+| Reviewed By | | | |
+
+---
+
+**Related Documents:**
+- SOP-LIC-001: License Management for Proprietary Outcome Measures
+- FRM-LIC-002: License Tracking Database
+- SOP-VAL-001: Measure Selection and Validation

Forms/License-Tracking/FRM-LIC-002-License-Tracking-Database.md

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+# License Tracking Database
+
+| Form ID | FRM-LIC-002 |
+|---------|-------------|
+| Form Title | License Tracking Database |
+| Version | 1.0 |
+| Effective Date | [DATE] |
+
+---
+
+## Purpose
+
+This database tracks all active licenses for proprietary clinical outcome measures to ensure compliance with license terms and timely renewals.
+
+## Instructions
+
+1. Create a new entry for each measure license
+2. Update status as actions are completed
+3. Set calendar reminders for renewal dates (90 days, 30 days, expiration)
+4. Review quarterly for accuracy and upcoming renewals
+5. Archive completed entries when measures are no longer in use
+
+---
+
+## License Tracking Table
+
+| Measure Name | Copyright Holder | License Number | License Type | Execution Date | Expiration Date | Covered Studies/Protocols | Cost | Payment Status | Renewal Status | File Location | Notes |
+|--------------|------------------|----------------|--------------|----------------|-----------------|---------------------------|------|----------------|----------------|---------------|-------|
+| | | | | | | | | | | | |
+| | | | | | | | | | | | |
+| | | | | | | | | | | | |
+| | | | | | | | | | | | |
+| | | | | | | | | | | | |
+| | | | | | | | | | | | |
+| | | | | | | | | | | | |
+
+## Field Definitions
+
+**Measure Name:** Full name and version of outcome measure
+
+**Copyright Holder:** Name of organization or individual holding copyright
+
+**License Number:** Unique identifier assigned by copyright holder
+
+**License Type:**
+- Single Study
+- Multi-Study
+- Institutional
+- Commercial
+- Other
+
+**Execution Date:** Date license agreement was signed
+
+**Expiration Date:** Date license expires (leave blank for perpetual licenses)
+
+**Covered Studies/Protocols:** List of protocols covered under this license
+
+**Cost:** Total license fee
+
+**Payment Status:**
+- Pending
+- Paid
+- Overdue
+
+**Renewal Status:**
+- Active
+- Renewal in Progress
+- Renewal Needed (90 days)
+- Renewal Urgent (30 days)
+- Expired
+- Discontinued
+
+**File Location:** Where executed license agreement is stored
+
+**Notes:** Restrictions, special terms, administrator requirements, etc.
+
+---
+
+## Quarterly Review
+
+Review Date: __________    Reviewed By: __________
+
+### Licenses Expiring in Next 90 Days
+
+| Measure | Expiration Date | Action Plan |
+|---------|----------------|-------------|
+| | | |
+| | | |
+
+### Issues Identified
+
+| Issue | Measure | Resolution Plan | Target Date |
+|-------|---------|----------------|-------------|
+| | | | |
+| | | | |
+
+### Action Items
+
+☐ Renewal reminders sent
+☐ All licenses current and compliant
+☐ Payment status verified
+☐ File locations confirmed accessible
+☐ New measures added to tracking
+☐ Discontinued measures archived
+
+Reviewer Signature: ________________    Date: __________
+
+---
+
+**Related Documents:**
+- SOP-LIC-001: License Management for Proprietary Outcome Measures
+- FRM-LIC-001: License Requirements Checklist
+- FRM-LIC-003: License Renewal Request Form

Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md

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+# Scoring Algorithm Documentation
+
+| Form ID | SCR-XXX |
+|---------|-------------|
+| Measure Name | |
+| Measure Version | |
+| Algorithm Version | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+
+---
+
+## 1. Measure Overview
+
+| Field | Information |
+|-------|-------------|
+| Full Measure Name | |
+| Measure Type | ☐ PRO  ☐ ClinRO  ☐ ObsRO  ☐ PerfO |
+| Copyright Holder | |
+| License Status | |
+| Number of Items | |
+| Subscales | |
+| Recall Period | |
+| Administration Time | |
+
+## 2. Item Response Coding
+
+### Response Format
+
+☐ Likert Scale
+☐ Visual Analog Scale (VAS)
+☐ Binary (Yes/No)
+☐ Numeric Rating Scale
+☐ Other: _____________________
+
+### Item Coding Table
+
+| Item Number | Item Content Summary | Response Options | Numeric Coding | Reverse Scored |
+|-------------|---------------------|------------------|----------------|----------------|
+| 1 | | | | ☐ Yes  ☐ No |
+| 2 | | | | ☐ Yes  ☐ No |
+| 3 | | | | ☐ Yes  ☐ No |
+| 4 | | | | ☐ Yes  ☐ No |
+| 5 | | | | ☐ Yes  ☐ No |
+
+[Continue for all items]
+
+## 3. Scoring Procedures
+
+### 3.1 Item-Level Scoring
+
+#### Step 1: Code Raw Responses
+- Convert response selections to numeric values per coding table
+- For VAS items: measure distance from anchor (usually in mm, 0-100)
+- For open-ended items: follow specific coding instructions
+
+#### Step 2: Reverse Score Items (if applicable)
+
+**Reverse-Scored Items:** [List item numbers]
+
+**Reverse Scoring Formula:**
+- For X-point scale: Reversed Score = (X + 1) - Raw Score
+- Example for 5-point scale: Reversed Score = 6 - Raw Score
+
+#### Step 3: Handle Missing Data
+
+**Missing Data Rules:**
+
+☐ **Prorated Scoring:** If ≥ ___% of items completed, prorate missing values
+  Formula: Scale Score = (Sum of completed items / Number of completed items) × Number of items in scale
+
+☐ **Person-Specific Mean Substitution:** Replace missing with person's mean on completed items
+
+☐ **No Imputation:** Score only if all items completed
+
+☐ **Copyright Holder Specified Rule:** ________________________________
+
+**Maximum Allowable Missing Data:**
+- Total scale: _____ items or _____%
+- Per subscale: _____ items or _____%
+
+### 3.2 Subscale Scoring
+
+| Subscale Name | Items Included | Scoring Formula | Possible Range | Higher Score Means |
+|---------------|----------------|-----------------|----------------|-------------------|
+| | | | | |
+| | | | | |
+| | | | | |
+
+**Subscale Calculation Steps:**
+1. Sum or average item scores per subscale
+2. Apply any subscale-specific transformations
+3. Round to _____ decimal places (specify)
+
+### 3.3 Total Score Calculation
+
+**Total Score Formula:**
+________________________________________________________________
+
+**Calculation Method:**
+☐ Sum of all items
+☐ Average of all items
+☐ Sum of subscales
+☐ Weighted sum: ______________________________________________
+☐ Other: ____________________________________________________
+
+**Possible Score Range:** Minimum: _____  Maximum: _____
+
+### 3.4 Transformations (if applicable)
+
+☐ **Linear Transformation**
+Formula: Transformed Score = ___________________________________
+
+☐ **T-Score Transformation**
+Formula: T = 50 + 10 × (Raw Score - Mean) / SD
+Population norms: Mean = _____  SD = _____
+
+☐ **Percentile Conversion**
+Reference normative data: _____________________________________
+
+☐ **IRT-Based Scoring**
+Scoring method: _______________________________________________
+Scoring software/table: ________________________________________
+
+## 4. Score Interpretation
+
+### 4.1 Descriptive Statistics
+
+**General Population Norms:**
+- Mean: _____
+- Standard Deviation: _____
+- Median: _____
+- Range: _____
+
+**Clinical Population Norms:**
+- Mean: _____
+- Standard Deviation: _____
+
+### 4.2 Clinical Cutoffs
+
+| Score Range | Severity Level | Clinical Interpretation |
+|-------------|---------------|------------------------|
+| | None/Minimal | |
+| | Mild | |
+| | Moderate | |
+| | Severe | |
+
+### 4.3 Minimal Clinically Important Difference (MCID)
+
+**Distribution-Based Estimates:**
+- 0.5 SD = _____
+- 1 SEM = _____
+
+**Anchor-Based Estimates:**
+- Based on [anchor]: MCID = _____
+- 95% CI: [_____ to _____]
+
+**Recommended MCID for Clinical Use:** _____
+
+Reference: ________________________________________________________
+
+### 4.4 Subscale Interpretation
+
+**Subscale 1: [Name]**
+- Score range: _____ to _____
+- Interpretation: ______________________________________________
+
+**Subscale 2: [Name]**
+- Score range: _____ to _____
+- Interpretation: ______________________________________________
+
+## 5. Quality Control Checks
+
+### 5.1 Data Quality Flags
+
+☐ All items within valid range
+☐ Required items completed
+☐ Logical consistency checks passed
+☐ Response patterns not suspicious (e.g., all same value)
+☐ Missing data within acceptable limits
+
+### 5.2 Common Scoring Errors to Avoid
+
+- [ ] Forgetting to reverse score applicable items
+- [ ] Incorrect handling of missing data
+- [ ] Using wrong subscale item groupings
+- [ ] Misinterpreting response codes
+- [ ] Applying transformations incorrectly
+- [ ] Using outdated scoring algorithms
+
+## 6. Implementation
+
+### 6.1 Manual Scoring
+
+**Required Materials:**
+- Completed measure form
+- Scoring template/worksheet
+- Calculator
+- Reverse scoring reference
+
+**Estimated Time:** _____ minutes per assessment
+
+### 6.2 Automated Scoring
+
+**Available Software/Systems:**
+- [ ] REDCap scoring module
+- [ ] eCOA platform automated scoring
+- [ ] Statistical software (SAS/R/SPSS) script
+- [ ] Excel scoring template
+- [ ] Copyright holder proprietary software
+- [ ] Other: _____________________
+
+**Software Version:** _____________
+
+**Validation Status:** ☐ Validated against manual scoring  ☐ Not validated
+
+### 6.3 eCOA Considerations
+
+☐ Real-time scoring at completion
+☐ Delayed scoring after data review
+☐ Immediate feedback to participant: ☐ Yes  ☐ No
+☐ Score visibility to clinician: ☐ Yes  ☐ No
+
+## 7. Documentation Requirements
+
+### 7.1 Scoring Records
+
+For each completed measure, maintain:
+- [ ] Original completed measure form (source document)
+- [ ] Scoring worksheet if manual scoring
+- [ ] Computed scores (all subscales and total)
+- [ ] Missing data documentation
+- [ ] Quality control verification
+- [ ] Scorer name/ID and date
+
+### 7.2 Algorithm Updates
+
+**Version Control:**
+- Document all changes to scoring algorithm
+- Maintain version history
+- Specify effective date for each version
+- Map to measure version
+- Obtain copyright holder approval if required
+
+## 8. References
+
+**Primary Source:**
+[Measure developer's manual or primary publication]
+
+**Validation Evidence:**
+[Key validation publications]
+
+**Normative Data:**
+[Sources for population norms]
+
+**MCID Evidence:**
+[Publications establishing MCID]
+
+## 9. Contact Information
+
+**For Scoring Questions:**
+[Internal expert contact]
+
+**Copyright Holder Support:**
+[Copyright holder contact information]
+
+---
+
+## Revision History
+
+| Version | Date | Changes | Approved By |
+|---------|------|---------|-------------|
+| 1.0 | [DATE] | Initial release | [APPROVER] |
+
+---
+
+**Related Documents:**
+- SOP-ADM-001: Clinical Outcome Measure Administration
+- WI-XXX: [Measure-Specific Work Instruction]
+- License Agreement: [License number]

Forms/Training/FRM-TRN-001-Administrator-Training-Record.md

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+# Administrator Training Record
+
+| Form ID | FRM-TRN-001 |
+|---------|-------------|
+| Form Title | Administrator Training Record |
+| Version | 1.0 |
+| Effective Date | [DATE] |
+
+---
+
+## Trainee Information
+
+| Field | Information |
+|-------|-------------|
+| Name | |
+| Employee/Study ID | |
+| Department/Site | |
+| Job Title/Role | |
+| Education Level | |
+| Clinical Credentials (if applicable) | |
+
+## Training Session Information
+
+| Field | Information |
+|-------|-------------|
+| Measure Name | |
+| Measure Version | |
+| Measure Type | ☐ PRO  ☐ ClinRO  ☐ ObsRO  ☐ PerfO |
+| Training Date | |
+| Training Duration | |
+| Training Location | ☐ In-Person  ☐ Virtual  ☐ Self-Study |
+| Training Materials Version | |
+
+## Trainer Information
+
+| Field | Information |
+|-------|-------------|
+| Trainer Name | |
+| Trainer Qualifications | |
+| Trainer Certification (if required) | |
+
+## Training Content Covered
+
+### General Training Topics
+
+☐ PRO/ClinRO/ObsRO/PerfO concepts and definitions
+☐ FDA PRO Guidance principles
+☐ Standardized administration techniques
+☐ Avoiding interviewer bias and response influence
+☐ Handling participant questions appropriately
+☐ Missing data minimization strategies
+☐ Data quality and integrity requirements
+☐ Good Clinical Practice (GCP) principles
+☐ Informed consent and research ethics
+☐ Privacy and confidentiality (HIPAA)
+
+### Measure-Specific Topics
+
+☐ Measure purpose and theoretical construct
+☐ Target population and intended use
+☐ Item content and response format
+☐ Recall period specification
+☐ Administration instructions (verbatim)
+☐ Timing and scheduling requirements
+☐ Scoring procedures and calculations
+☐ Score interpretation and clinical meaning
+☐ Handling incomplete responses
+☐ Common administration errors to avoid
+☐ Special considerations for this measure
+
+### Additional Training (check all that apply)
+
+☐ Electronic administration (eCOA platform training)
+☐ Paper backup procedures
+☐ Translation and language-specific considerations
+☐ Cultural adaptation considerations
+☐ Safety procedures (for PerfO)
+☐ Equipment operation (for PerfO)
+☐ Inter-rater reliability procedures (for ClinRO)
+
+## Practical Components Completed
+
+☐ Review of measure items and instructions
+☐ Observation of demonstration administration
+☐ Mock administration with standardized participant
+☐ Role-play practice with feedback
+☐ Video review of administration technique
+☐ Inter-rater reliability exercise (for ClinRO)
+☐ Scoring practice with sample data
+☐ eCOA system navigation practice
+
+## Knowledge Assessment
+
+### Written Test
+
+Test Version: __________
+
+Number of Questions: __________
+
+Score: __________ / __________     Percentage: __________%
+
+☐ Pass (≥80%)     ☐ Fail (<80%)
+
+If failed: Remediation plan and retest date: _________________________
+
+### Practical Assessment
+
+☐ Pass - Demonstrated competent administration
+☐ Fail - Additional training needed
+
+Specific areas needing improvement: _________________________________
+________________________________________________________________
+________________________________________________________________
+
+## Competency Determination
+
+☐ **COMPETENT** - May administer measure independently
+☐ **NOT YET COMPETENT** - Additional training/supervision required
+
+Competency achieved on: __________
+
+Specific limitations or supervision requirements: _____________________
+________________________________________________________________
+
+## Copyright Holder Certification (if applicable)
+
+Certification Required: ☐ Yes  ☐ No
+
+If Yes:
+Certification Program: ___________________________________________
+Certification Number: ___________________________________________
+Certification Date: __________
+Expiration Date: __________
+Certificate on file: ☐ Yes  ☐ No
+
+## Study/Protocol Assignment
+
+This training qualifies the administrator for the following studies/protocols:
+
+| Protocol Number | Protocol Title | Principal Investigator |
+|----------------|----------------|----------------------|
+| | | |
+| | | |
+| | | |
+
+## Signatures
+
+**I certify that I have completed the training described above and understand the requirements for administering this outcome measure. I will follow all procedures as trained and seek guidance when uncertain.**
+
+Trainee Signature: ______________________    Date: __________
+
+**I certify that the trainee named above has successfully completed training and demonstrated competence in administering this outcome measure.**
+
+Trainer Signature: ______________________    Date: __________
+
+**I approve this individual to independently administer this outcome measure in the assigned studies/protocols.**
+
+Supervisor Signature: ______________________    Date: __________
+
+---
+
+## Retraining/Recertification Record
+
+| Date | Reason for Retraining | Trainer | Result |
+|------|----------------------|---------|--------|
+| | ☐ Measure update  ☐ Performance issue  ☐ Extended absence  ☐ Certification renewal  ☐ Other: _____ | | ☐ Pass  ☐ Fail |
+| | | | |
+| | | | |
+
+---
+
+## Distribution
+
+Original: Personnel Training File
+Copy: Study File
+Copy: Training Database
+
+**Record Retention:** Duration of employment + 3 years minimum; per study protocol requirements
+
+---
+
+**Related Documents:**
+- SOP-GEN-002: Training and Competence for Measure Administration
+- SOP-ADM-001: Clinical Outcome Measure Administration
+- FRM-TRN-002: Competency Assessment Form

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

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+# 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 | |
+
+---
+
+## Protocol Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Principal Investigator | | | |
+| Biostatistician | | | |
+| Quality Manager | | | |
+
+---
+
+**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