Sync template from atomicqms-style deployment

.gitea/workflows/atomicai.yml

@@ -0,0 +1,90 @@
+name: AtomicAI Clinical Measure Repository Assistant
+
+on:
+  issue_comment:
+    types: [created]
+  issues:
+    types: [opened, assigned]
+  pull_request:
+    types: [opened, synchronize, assigned]
+  pull_request_review_comment:
+    types: [created]
+
+jobs:
+  claude-assistant:
+    runs-on: ubuntu-latest
+    if: |
+      github.actor != 'atomicqms-service' &&
+      (
+      (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
+      (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
+      (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
+      (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
+      (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
+
+      )
+    permissions:
+      contents: write
+      issues: write
+      pull-requests: write
+
+    steps:
+      - uses: actions/checkout@v4
+        with:
+          fetch-depth: 0
+
+      - name: Run AtomicAI Clinical Measure Repository Assistant
+        uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
+        with:
+          trigger_phrase: '@atomicai'
+          assignee_trigger: 'atomicai'
+          claude_git_name: 'AtomicAI'
+          claude_git_email: 'atomicai@atomicqms.local'
+          custom_instructions: |
+            You are AtomicAI, an AI assistant specialized in Clinical Outcome Measures and Patient-Reported Outcomes Quality Management.
+
+            ## Your Expertise
+            - Clinical outcome measure development and validation
+            - Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs)
+            - Performance Outcomes (PerfOs) and objective assessments
+            - FDA PRO Guidance and BEST (Biomarkers, EndpointS, and other Tools) Framework
+            - Psychometric validation: reliability, validity, responsiveness, interpretability
+            - Measure licensing, copyright, and intellectual property management
+            - Translation and linguistic validation (ISPOR guidelines)
+            - Electronic Clinical Outcome Assessment (eCOA) protocols
+            - Scoring algorithms and normative data interpretation
+            - Measure administration training and certification requirements
+            - PROMIS (Patient-Reported Outcomes Measurement Information System)
+            - NIH Toolbox, COSMIN guidelines, Consensus-based Standards for the selection of health Measurement Instruments
+
+            ## Document Creation Guidelines
+            - Place Licensing SOPs in SOPs/Licensing/
+            - Place Validation SOPs in SOPs/Validation/
+            - Place Administration SOPs in SOPs/Administration/
+            - Place Translation SOPs in SOPs/Translation/
+            - Place Data Management SOPs in SOPs/Data-Management/
+            - Place General SOPs in SOPs/General/
+            - Place License tracking forms in Forms/License-Tracking/
+            - Place Validation records in Forms/Validation-Records/
+            - Place Training records in Forms/Training/
+            - Place Scoring documentation in Forms/Scoring/
+            - Place Work Instructions in Work Instructions/
+
+            ## Numbering Convention
+            - POL-XXX for Policies
+            - SOP-LIC-XXX for Licensing SOPs
+            - SOP-VAL-XXX for Validation SOPs
+            - SOP-ADM-XXX for Administration SOPs
+            - SOP-TRN-XXX for Translation SOPs
+            - SOP-DM-XXX for Data Management SOPs
+            - SOP-GEN-XXX for General SOPs
+            - WI-XXX for Work Instructions
+            - FRM-XXX for Forms
+            - LIC-XXX for License Agreements/Tracking
+            - VAL-XXX for Validation Reports
+            - SCR-XXX for Scoring Algorithms
+
+            Always create branches and submit changes as Pull Requests for review.
+            Include regulatory references (FDA PRO Guidance, ICH E9, ISPOR) where applicable.
+          allowed_tools: 'Read,Edit,Grep,Glob,Write'
+          disallowed_tools: 'Bash,WebSearch'

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

@@ -0,0 +1,145 @@
+# 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

@@ -0,0 +1,113 @@
+# 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

@@ -0,0 +1,281 @@
+# 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

@@ -0,0 +1,185 @@
+# 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

@@ -0,0 +1,315 @@
+# 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

Policies/POL-001-Quality-Policy.md

@@ -0,0 +1,104 @@
+# Quality Policy - Clinical Outcome Measures Management
+
+| Document ID | POL-001 |
+|-------------|---------|
+| Title | Quality Policy - Clinical Outcome Measures Management |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+
+---
+
+## 1. Policy Statement
+
+[ORGANIZATION NAME] is committed to maintaining the highest standards in clinical outcome measure development, validation, implementation, and data management. We ensure that all patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs) used in our research and clinical programs meet rigorous psychometric standards and regulatory requirements.
+
+## 2. Quality Objectives
+
+Our organization commits to:
+
+1. **Scientific Rigor**: Ensuring all outcome measures demonstrate appropriate reliability, validity, responsiveness, and interpretability
+2. **Regulatory Compliance**: Maintaining compliance with FDA PRO Guidance, ICH guidelines, and other applicable regulations
+3. **Intellectual Property Protection**: Respecting copyright, licensing requirements, and intellectual property rights for all proprietary measures
+4. **Cultural Sensitivity**: Ensuring proper translation and linguistic validation for international use
+5. **Data Integrity**: Maintaining accurate scoring, data collection, and outcome assessment procedures
+6. **Training Excellence**: Ensuring all personnel are appropriately trained and certified in measure administration
+7. **Continuous Improvement**: Regularly reviewing and updating measure selection, validation, and implementation procedures
+
+## 3. Management Commitment
+
+Top management demonstrates commitment to clinical outcome measure quality by:
+
+- Ensuring adequate resources for psychometric validation studies
+- Supporting proper licensing and intellectual property management
+- Promoting evidence-based measure selection aligned with study objectives
+- Ensuring translation and linguistic validation follow ISPOR guidelines
+- Maintaining separation between clinical care and research assessments where appropriate
+- Supporting training and certification programs for measure administrators
+- Ensuring electronic clinical outcome assessment (eCOA) systems meet 21 CFR Part 11 requirements
+- Engaging with measure developers, copyright holders, and licensing organizations appropriately
+- Reviewing measure performance data and validation evidence regularly
+
+## 4. Scope
+
+This policy applies to:
+- All clinical outcome measures used in research studies
+- Patient-reported, clinician-reported, observer-reported, and performance outcomes
+- Psychometric validation activities
+- Measure licensing and copyright management
+- Translation and linguistic validation projects
+- Training and certification of measure administrators
+- Electronic and paper-based outcome assessment systems
+- Scoring algorithms and data interpretation procedures
+
+## 5. Key Principles
+
+### 5.1 Measure Selection
+- Select measures with demonstrated psychometric properties appropriate to the study population and objectives
+- Consider respondent burden, literacy requirements, and cultural appropriateness
+- Document rationale for measure selection with reference to published validation evidence
+- Obtain necessary licenses and permissions before use
+
+### 5.2 Psychometric Validation
+- Conduct validation studies following established methodologies (COSMIN, FDA PRO Guidance)
+- Document reliability (internal consistency, test-retest, inter-rater)
+- Establish validity (content, construct, criterion)
+- Assess responsiveness and minimal clinically important difference (MCID)
+- Generate normative data or reference values when appropriate
+
+### 5.3 Licensing & Copyright
+- Identify and track all proprietary measures requiring licenses
+- Maintain current license agreements and ensure compliance with terms
+- Track license renewal dates and usage restrictions
+- Document copyright attributions and obtain permissions for modifications
+- Manage royalty payments for commercial use
+
+### 5.4 Translation & Linguistic Validation
+- Follow ISPOR principles of good practice for translation and linguistic validation
+- Use forward-backward translation methodology
+- Conduct cognitive debriefing with target population
+- Obtain linguistic validation certificates
+- Maintain version control for all language versions
+
+### 5.5 Training & Certification
+- Ensure administrators are trained in measure-specific procedures
+- Document training completion and certification status
+- Maintain competency through periodic refresher training
+- Follow measure developer requirements for administrator qualifications
+
+## 6. Communication
+
+This policy shall be:
+- Communicated to all personnel involved in outcome measure activities
+- Available to study sponsors, regulatory authorities, and other stakeholders as appropriate
+- Reviewed annually for continuing suitability
+- Updated to reflect changes in regulatory requirements and scientific best practices
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

README.md

@@ -1,3 +1,117 @@
-# measure-repository
+# Clinical Measure Repository Quality Management System
 
-This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Outcome Measures** and **Patient-Reported Outcomes (PRO)** repositories.
+This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Outcome Measures** and **Patient-Reported Outcomes (PRO)** repositories.
+
+## 📊 Designed For
+
+- Clinical Research Organizations managing outcome measures
+- Academic Medical Centers with measure development programs
+- Healthcare Quality Improvement departments
+- Psychometric Validation Teams
+- PRO/eCOA Implementation Teams
+- Clinical Trial Operations using validated measures
+- Registry Programs tracking clinical outcomes
+- Health Economics and Outcomes Research (HEOR) groups
+
+## Repository Structure
+
+```
+measure-repository/
+├── Policies/                  # Quality policies for measure management
+├── SOPs/                      # Standard Operating Procedures
+│   ├── Licensing/             # License agreements & copyright management
+│   ├── Validation/            # Psychometric validation procedures
+│   ├── Administration/        # Measure administration protocols
+│   ├── Translation/           # Translation & linguistic validation
+│   ├── Data-Management/       # Data collection, scoring, storage
+│   └── General/               # General quality operations
+├── Work Instructions/         # Detailed protocols and procedures
+├── Forms/                     # Record forms and templates
+│   ├── License-Tracking/      # License agreements & renewals
+│   ├── Validation-Records/    # Validation study documentation
+│   ├── Training/              # Administrator training records
+│   └── Scoring/               # Scoring algorithms & interpretations
+└── Templates/                 # Document templates
+```
+
+## Outcome Measure Types Covered
+
+- **PRO** - Patient-Reported Outcomes (e.g., SF-36, PROMIS, PHQ-9)
+- **ClinRO** - Clinician-Reported Outcomes (e.g., CGI-S, YBOCS)
+- **ObsRO** - Observer-Reported Outcomes (caregiver/proxy reports)
+- **PerfO** - Performance Outcomes (objective assessments, e.g., 6MWT, cognitive tests)
+
+## Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-LIC-XXX**: Licensing SOPs
+- **SOP-VAL-XXX**: Validation SOPs
+- **SOP-ADM-XXX**: Administration SOPs
+- **SOP-TRN-XXX**: Translation SOPs
+- **SOP-DM-XXX**: Data Management SOPs
+- **SOP-GEN-XXX**: General SOPs
+- **WI-XXX**: Work Instructions / Protocols
+- **FRM-XXX**: Forms and Records
+- **LIC-XXX**: License Agreements/Tracking
+- **VAL-XXX**: Validation Reports
+- **SCR-XXX**: Scoring Algorithms
+
+## 🤖 AI-Powered Document Creation
+
+This template includes **AtomicAI** integration. Create an issue and mention `@atomicai` to:
+- Generate SOPs for measure licensing and copyright management
+- Create validation study protocols and documentation
+- Draft training materials for measure administrators
+- Develop scoring algorithms and interpretation guides
+- Create translation and linguistic validation procedures
+- Generate electronic vs paper administration protocols
+
+## Getting Started
+
+1. Create a new repository using this template
+2. Customize documents with your organization's information
+3. Add your validated measures to appropriate directories
+4. Create issues with `@atomicai` to generate new documents
+5. Review and approve AI-generated content via Pull Requests
+
+## Compliance & Best Practices
+
+These templates support compliance with:
+- **FDA PRO Guidance** (2009) - Patient-Reported Outcome Measures
+- **FDA BEST Framework** - Biomarkers, EndpointS, and other Tools
+- **ICH E9** - Statistical Principles for Clinical Trials
+- **ISPOR Guidelines** - Translation and Linguistic Validation
+- **COSMIN** - COnsensus-based Standards for the selection of health Measurement INstruments
+- **PROMIS** Standards - Patient-Reported Outcomes Measurement Information System
+- **21 CFR Part 11** - Electronic Records (for eCOA)
+- **HIPAA** - Health Information Privacy
+- **GDPR** - Data Protection (international studies)
+
+## Key Quality Considerations
+
+### Psychometric Properties
+- **Reliability**: Internal consistency, test-retest, inter-rater
+- **Validity**: Content, construct, criterion, known-groups
+- **Responsiveness**: Ability to detect meaningful change
+- **Interpretability**: Minimal clinically important difference (MCID), normative data
+
+### Licensing & Copyright
+- Track proprietary measure licenses and renewals
+- Maintain permissions for use, modification, and translation
+- Document copyright restrictions and attribution requirements
+- Manage royalty agreements for commercial use
+
+### Translation Management
+- Forward-backward translation methodology
+- Cultural adaptation and cognitive debriefing
+- Linguistic validation certificates
+- Version control for multi-language instruments
+
+### Administration Standards
+- Training and certification requirements for administrators
+- Paper vs electronic administration equivalence
+- Recall period and timing specifications
+- Instructions and response option standardization
+
+---
+*Powered by AtomicQMS - AI-Enhanced Clinical Measure Quality Management*

SOPs/Administration/SOP-ADM-001-Measure-Administration.md

@@ -0,0 +1,312 @@
+# Standard Operating Procedure: Clinical Outcome Measure Administration
+
+| Document ID | SOP-ADM-001 |
+|-------------|---------|
+| Title | Clinical Outcome Measure Administration |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Clinical Operations |
+
+---
+
+## 1. Purpose
+
+This procedure establishes standardized requirements for administering clinical outcome measures to ensure data quality, consistency, and validity across all assessments.
+
+## 2. Scope
+
+This procedure applies to:
+- Patient-Reported Outcomes (PROs)
+- Clinician-Reported Outcomes (ClinROs)
+- Observer-Reported Outcomes (ObsROs)
+- Performance Outcomes (PerfOs)
+
+Administered in any setting (clinic, home, remote) using paper or electronic formats.
+
+## 3. Responsibilities
+
+### 3.1 Study Coordinator/Clinical Research Associate
+- Schedule outcome assessments
+- Ensure measures are administered according to protocol
+- Maintain assessment materials and equipment
+- Document completion and data quality
+
+### 3.2 Measure Administrator
+- Complete required training for each measure
+- Follow standardized administration procedures
+- Respond to participant questions appropriately
+- Maintain certification as required
+
+### 3.3 Quality Assurance
+- Monitor administration compliance
+- Review assessment data for quality issues
+- Provide feedback and retraining as needed
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| PRO | Patient-Reported Outcome - Self-reported by patient without interpretation by clinician or observer |
+| ClinRO | Clinician-Reported Outcome - Based on clinician observation and professional judgment |
+| ObsRO | Observer-Reported Outcome - Based on caregiver/proxy observation without clinical interpretation |
+| PerfO | Performance Outcome - Based on standardized task performed by patient (e.g., timed walk test) |
+| Recall Period | The timeframe patients consider when responding (e.g., "in the past week") |
+| Response Options | The available choices for answering items (e.g., Likert scale, visual analog scale) |
+| Missing Data | Items not completed or answered "don't know/not applicable" |
+
+## 5. Procedure
+
+### 5.1 Pre-Administration Preparation
+
+5.1.1. Verify administrator training and certification:
+   - Review measure-specific training requirements
+   - Confirm completion in training database
+   - Check certification expiration dates
+   - Complete refresher training if needed
+
+5.1.2. Verify active license for proprietary measures:
+   - Check License Tracking Database
+   - Ensure protocol is covered under current license
+   - Review any license restrictions or requirements
+
+5.1.3. Gather required materials:
+   - Current version of measure
+   - Administration manual/instructions
+   - Response forms or electronic device
+   - Scoring materials if immediate scoring required
+   - Equipment for performance measures
+
+5.1.4. Review protocol-specific requirements:
+   - Timing of assessment (visit window)
+   - Order of measures if multiple assessments
+   - Special population considerations
+   - Conditions for assessment (fasting, medication timing, etc.)
+
+5.1.5. Prepare assessment environment:
+   - Private, quiet location
+   - Adequate lighting
+   - Comfortable seating
+   - Free from interruptions
+
+### 5.2 Patient-Reported Outcomes (PRO) Administration
+
+#### 5.2.1 Self-Administered PROs
+
+5.2.1.1. Provide standardized introduction:
+   - Explain purpose of assessment
+   - Emphasize there are no right or wrong answers
+   - Clarify that responses are confidential
+   - Ask participant to complete independently
+
+5.2.1.2. Provide written or verbal instructions:
+   - Read recall period carefully
+   - Indicate how to mark responses
+   - Complete all items unless instructed otherwise
+   - Ask questions if anything is unclear
+
+5.2.1.3. Allow participant to complete independently:
+   - Remain available for questions
+   - Do not observe or read over shoulder
+   - Provide clarification only on instructions, not items
+   - Do not influence responses
+
+5.2.1.4. Check for completeness:
+   - Review for missing items
+   - Ask participant to complete skipped items if appropriate
+   - Document reason if items remain incomplete
+   - Do not query or suggest changes to responses
+
+#### 5.2.2 Interviewer-Administered PROs
+
+5.2.2.1. Read standardized introduction script
+
+5.2.2.2. Read items verbatim:
+   - Do not paraphrase or explain items
+   - Repeat item if participant did not hear or understand
+   - If participant still unclear, document as "unable to understand"
+
+5.2.2.3. Read response options clearly:
+   - Present all available response options
+   - May use response cards for visual reference
+   - Allow participant to answer in their own words, then map to options
+
+5.2.2.4. Record responses accurately:
+   - Mark participant's initial response
+   - Do not query or seek clarification of responses
+   - If participant changes answer, record final response
+
+5.2.2.5. Handle participant questions:
+   - Questions about instructions: answer clearly
+   - Questions about item meaning: repeat item only
+   - Questions about which response to choose: "whatever is most accurate for you"
+
+### 5.3 Clinician-Reported Outcomes (ClinRO) Administration
+
+5.3.1. Review available clinical information:
+   - Recent medical records
+   - Laboratory/diagnostic results
+   - Previous ClinRO scores for comparison
+
+5.3.2. Conduct clinical evaluation:
+   - Patient interview if required
+   - Physical examination if required
+   - Review of symptoms and functional status
+
+5.3.3. Apply clinical judgment:
+   - Consider all available information
+   - Rate according to measure definitions
+   - Use anchors and examples provided in measure
+   - Document supporting observations
+
+5.3.4. Complete independently:
+   - Do not confer with other raters before rating
+   - For training/reliability, may compare after independent rating
+   - Document any disagreements and resolution process
+
+### 5.4 Observer-Reported Outcomes (ObsRO) Administration
+
+5.4.1. Verify observer qualifications:
+   - Appropriate relationship to patient (caregiver, parent, etc.)
+   - Adequate opportunity to observe relevant behaviors
+   - Adequate cognitive ability to complete assessment
+
+5.4.2. Provide observer instructions:
+   - Base responses on direct observation
+   - Consider specified recall period
+   - Answer based on what you have observed, not what you think
+
+5.4.3. Follow PRO administration procedures (Section 5.2)
+
+5.4.4. Consider proxy response implications:
+   - Patient-proxy agreement may vary by domain
+   - Document observer relationship and contact frequency
+   - Note if patient unable to self-report and reason
+
+### 5.5 Performance Outcomes (PerfO) Administration
+
+5.5.1. Ensure standardized conditions:
+   - Consistent time of day if performance varies
+   - Consider effects of medications or meals
+   - Appropriate rest before assessment
+   - Safe environment and equipment
+
+5.5.2. Demonstrate task if required:
+   - Follow standardized demonstration script
+   - Ensure participant understands task
+   - Allow practice trial if permitted
+
+5.5.3. Administer performance test:
+   - Use standardized instructions verbatim
+   - Follow specified timing procedures
+   - Apply stopping rules if specified
+   - Ensure safety throughout
+
+5.5.4. Record performance objectively:
+   - Time, distance, or other metrics
+   - Note any deviations from standard administration
+   - Document reasons for incomplete assessments
+
+5.5.5. Provide feedback appropriately:
+   - Follow measure guidelines on feedback
+   - Generally, do not provide performance results immediately
+   - Thank participant for effort
+
+### 5.6 Electronic Administration (eCOA)
+
+5.6.1. Verify electronic system:
+   - System is functioning properly
+   - Correct measure and version loaded
+   - Appropriate participant ID entered
+   - Data connection available if required
+
+5.6.2. Provide device orientation:
+   - How to read and respond to items
+   - How to navigate forward/backward if permitted
+   - How to submit/save responses
+   - Technical support contact information
+
+5.6.3. Monitor for technical issues:
+   - Device malfunction
+   - Software errors
+   - Loss of data connection
+   - Document issues and resolution
+
+5.6.4. Have paper backup available:
+   - Use only if electronic system failure
+   - Document reason for paper administration
+   - Follow procedures for paper-to-electronic data entry
+
+### 5.7 Timing and Scheduling
+
+5.7.1. Adhere to protocol visit windows:
+   - Schedule within specified timeframe
+   - Document actual assessment date and time
+   - If outside window, document reason
+
+5.7.2. Consider order effects:
+   - Follow protocol-specified order if required
+   - For fatigue-sensitive measures, administer early
+   - Allow breaks between measures if needed
+
+5.7.3. Avoid contamination:
+   - PROs before clinical assessments when possible
+   - Blind PRO responses from clinicians when appropriate
+   - ClinRO raters blind to other outcomes when required
+
+### 5.8 Missing Data Management
+
+5.8.1. Minimize missing data:
+   - Review for completeness during visit
+   - Ask participant to complete missed items when appropriate
+   - Document reason if items not completed
+
+5.8.2. Acceptable reasons for missing items:
+   - Item not applicable to participant
+   - Participant refused to answer
+   - Participant unable to understand item
+   - Technical issue prevented response capture
+
+5.8.3. Unacceptable approaches:
+   - Administrator answering on behalf of participant
+   - Coercing responses
+   - Querying responses to reduce variability
+   - Imputing responses during administration
+
+### 5.9 Documentation
+
+5.9.1. Complete required documentation:
+   - Assessment completion log
+   - Deviations from standard administration
+   - Missing data with reasons
+   - Technical issues or protocol deviations
+   - Administrator name and date
+
+5.9.2. Ensure data quality:
+   - Verify all required items completed
+   - Check for logical inconsistencies
+   - Resolve data queries promptly
+   - Maintain source documentation
+
+## 6. Related Documents
+
+- WI-XXX: Measure-specific work instructions
+- FRM-ADM-001: Assessment Completion Log
+- FRM-TRN-001: Administrator Training Record
+- SOP-DM-001: Data Management
+- SOP-LIC-001: License Management
+
+## 7. References
+
+- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures
+- Acquadro C, et al. (2008). Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration
+- EMA (2005). Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-GEN-001-Document-Control.md

@@ -0,0 +1,219 @@
+# Standard Operating Procedure: Document Control
+
+| Document ID | SOP-GEN-001 |
+|-------------|---------|
+| Title | Document Control |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a procedure for the creation, review, approval, distribution, and control of documents within the Measure Repository Quality Management System.
+
+## 2. Scope
+
+This procedure applies to all controlled documents including:
+- Policies
+- Standard Operating Procedures (SOPs)
+- Work Instructions
+- Forms and Templates
+- Validation Reports
+- License Agreements
+- Translation Certificates
+- Measure Administration Manuals
+
+## 3. Responsibilities
+
+### 3.1 Document Owner
+- Responsible for document content and accuracy
+- Initiates document creation and revision
+- Ensures periodic review is performed
+- Reviews validation evidence and updates
+
+### 3.2 Quality Manager
+- Maintains the document control system
+- Assigns document numbers
+- Manages document distribution
+- Archives obsolete documents
+- Tracks measure version control
+
+### 3.3 Approvers
+- Review and approve documents before release
+- Ensure documents are adequate for intended purpose
+- Verify compliance with regulatory requirements (FDA PRO Guidance, ISPOR)
+
+## 4. Procedure
+
+### 4.1 Document Creation
+
+4.1.1. Identify the need for a new document
+
+4.1.2. Request document number from Quality Manager
+
+4.1.3. Draft document using appropriate template
+
+4.1.4. Include all required header information:
+   - Document ID
+   - Title
+   - Revision number
+   - Effective date
+   - Author and approver names
+   - Department
+
+4.1.5. Submit for review and approval
+
+### 4.2 Document Review and Approval
+
+4.2.1. Route document to appropriate reviewers:
+   - Subject matter experts
+   - Measure copyright holders (if applicable)
+   - Regulatory affairs (for validation reports)
+   - Legal (for license agreements)
+
+4.2.2. Reviewers provide comments within 5 business days
+
+4.2.3. Author addresses all comments
+
+4.2.4. Final approval by designated approver
+
+4.2.5. Quality Manager releases document
+
+4.2.6. Distribute to relevant personnel and training system
+
+### 4.3 Document Numbering
+
+Documents shall be numbered according to the following convention:
+
+| Type | Prefix | Example |
+|------|--------|---------|
+| Policy | POL | POL-001 |
+| Licensing SOP | SOP-LIC | SOP-LIC-001 |
+| Validation SOP | SOP-VAL | SOP-VAL-001 |
+| Administration SOP | SOP-ADM | SOP-ADM-001 |
+| Translation SOP | SOP-TRN | SOP-TRN-001 |
+| Data Management SOP | SOP-DM | SOP-DM-001 |
+| General SOP | SOP-GEN | SOP-GEN-001 |
+| Work Instruction | WI | WI-001 |
+| Form | FRM | FRM-001 |
+| License Document | LIC | LIC-001 |
+| Validation Report | VAL | VAL-001 |
+| Scoring Algorithm | SCR | SCR-001 |
+
+### 4.4 Measure Version Control
+
+4.4.1. Track all versions of clinical outcome measures:
+   - Original measure version
+   - Translated versions with language code
+   - Modified or adapted versions
+   - Electronic format versions (eCOA)
+
+4.4.2. Version naming convention:
+   - [Measure Name]_v[Version]_[Language]_[Date]
+   - Example: PHQ9_v1.0_EN-US_2024-01-15
+
+4.4.3. Maintain version history documentation:
+   - Changes between versions
+   - Rationale for modifications
+   - Validation status of each version
+   - Copyright holder approval for changes
+
+### 4.5 Revision Control
+
+4.5.1. All changes require documented justification
+
+4.5.2. Changes follow same review/approval process as new documents
+
+4.5.3. Revision numbering:
+   - Major revisions: increment whole number (1.0 → 2.0)
+   - Minor revisions: increment decimal (1.0 → 1.1)
+
+4.5.4. Revision history maintained in document footer
+
+4.5.5. For measure revisions, verify:
+   - Copyright holder approval obtained
+   - License permits modifications
+   - Psychometric impact assessed
+   - Revalidation needs determined
+
+### 4.6 Document Distribution
+
+4.6.1. Current versions available in document control system (Git repository)
+
+4.6.2. Obsolete versions clearly marked and archived in separate branch/folder
+
+4.6.3. Training on new/revised documents as needed
+
+4.6.4. Notification sent to all affected personnel
+
+4.6.5. For measures used in ongoing studies:
+   - Coordinate version updates with study teams
+   - Ensure continuity of measurement
+   - Document version used at each timepoint
+
+### 4.7 Periodic Review
+
+4.7.1. Documents reviewed at least every 2 years
+
+4.7.2. SOPs related to regulatory requirements reviewed when regulations update
+
+4.7.3. Validation reports reviewed when new evidence published
+
+4.7.4. License agreements reviewed 90 days before expiration
+
+4.7.5. Review documented even if no changes made
+
+4.7.6. Reviews may result in:
+   - Revision (with documented changes)
+   - Reaffirmation (no changes needed)
+   - Retirement (document obsolete)
+
+### 4.8 Special Considerations for Measure Documents
+
+#### 4.8.1 Validation Reports
+- Archive raw validation data separately
+- Link to statistical analysis files
+- Maintain in compliance with 21 CFR Part 11 if electronic
+- Update when additional validation evidence obtained
+
+#### 4.8.2 License Agreements
+- Store executed agreements securely
+- Maintain access log for auditing
+- Set expiration reminders (90 and 30 days)
+- Coordinate with legal department
+
+#### 4.8.3 Translation Certificates
+- Link to linguistic validation report
+- Document copyright holder approval
+- Track all language versions
+- Maintain translator qualifications
+
+## 5. Related Documents
+
+- FRM-GEN-001: Document Change Request Form
+- FRM-GEN-002: Document Review Record
+- SOP-LIC-001: License Management
+- SOP-TRN-001: Translation and Linguistic Validation
+- SOP-VAL-001: Psychometric Validation
+
+## 6. Definitions
+
+| Term | Definition |
+|------|------------|
+| Controlled Document | Document managed under document control system with versioning and approval |
+| Obsolete | Document no longer valid for use |
+| Revision | Updated version of a document |
+| Measure Version | Specific iteration of a clinical outcome measure with documented changes |
+| Source Document | Original documentation supporting measure development or validation |
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-GEN-002-Training-Competence.md

@@ -0,0 +1,317 @@
+# Standard Operating Procedure: Training and Competence for Measure Administration
+
+| Document ID | SOP-GEN-002 |
+|-------------|---------|
+| Title | Training and Competence for Measure Administration |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance / Training |
+
+---
+
+## 1. Purpose
+
+To ensure personnel administering clinical outcome measures are competent based on appropriate education, training, skills, and experience, and meet measure-specific certification requirements.
+
+## 2. Scope
+
+This procedure applies to:
+- All personnel administering outcome measures (PRO, ClinRO, ObsRO, PerfO)
+- Research coordinators and clinical research associates
+- Clinician raters for ClinRO measures
+- Personnel involved in measure scoring and interpretation
+- Translation and validation study personnel
+
+## 3. Responsibilities
+
+### 3.1 Study Coordinators/Supervisors
+- Identify training needs for measure administrators
+- Ensure training completed before measure administration
+- Evaluate competence of personnel
+- Maintain department training records
+- Track measure-specific certification expiration dates
+
+### 3.2 Training Coordinator
+- Coordinate training programs and schedules
+- Maintain central training database
+- Track training compliance and certification status
+- Archive training records per regulatory requirements
+- Coordinate with measure copyright holders for certified training
+
+### 3.3 Quality Manager
+- Develop QMS-related training curriculum
+- Approve training curricula for outcome measures
+- Audit training compliance
+- Review training effectiveness
+- Ensure alignment with FDA PRO Guidance and ISPOR standards
+
+### 3.4 Measure Administrators
+- Complete assigned training before administering measures
+- Maintain current qualifications and certifications
+- Report training needs to supervisor
+- Follow standardized administration procedures
+- Participate in competency assessments
+
+## 4. Procedure
+
+### 4.1 Training Needs Assessment
+
+4.1.1. Identify competence requirements for each role:
+   - Education level (e.g., clinical degree for ClinRO raters)
+   - Clinical experience requirements
+   - Prior assessment experience
+   - Language proficiency for multilingual studies
+
+4.1.2. Document requirements in job descriptions
+
+4.1.3. Assess current competence of personnel:
+   - Review credentials and experience
+   - Review prior training records
+   - Identify measure-specific training gaps
+
+4.1.4. For each measure, determine:
+   - General administration training needs
+   - Measure-specific requirements
+   - Copyright holder certification requirements
+   - Ongoing competency assessment needs
+
+### 4.2 Training Curriculum Development
+
+4.2.1. General Outcome Assessment Training:
+   - PRO/ClinRO/ObsRO/PerfO concepts
+   - FDA PRO Guidance principles
+   - Standardized administration techniques
+   - Avoiding response bias
+   - Handling participant questions
+   - Missing data minimization
+   - Data quality and integrity
+   - GCP and research ethics
+
+4.2.2. Measure-Specific Training:
+   - Measure purpose and construct
+   - Items and response format
+   - Recall period
+   - Scoring procedures
+   - Interpretation guidelines
+   - Common administration errors
+   - Measure-specific considerations
+
+4.2.3. Define learning objectives
+
+4.2.4. Develop training materials:
+   - Presentations
+   - Administration manuals
+   - Video demonstrations
+   - Practice cases
+   - Assessment tools
+
+4.2.5. Identify delivery method:
+   - Classroom/workshop
+   - One-on-one training
+   - Self-study with assessment
+   - Computer-based training
+   - Webinar (live or recorded)
+   - Copyright holder certified training program
+
+4.2.6. Define assessment criteria:
+   - Written test (minimum 80% passing)
+   - Practical demonstration with standardized participants
+   - Inter-rater reliability assessment for ClinRO
+   - Supervisor observation and sign-off
+
+4.2.7. Obtain approval from Quality Manager
+
+4.2.8. For proprietary measures requiring certification:
+   - Coordinate with copyright holder
+   - Use approved training materials only
+   - Follow certification process as specified
+   - Maintain certificates on file
+
+### 4.3 Training Delivery
+
+4.3.1. Schedule training session allowing adequate preparation time
+
+4.3.2. Document attendance with sign-in sheet
+
+4.3.3. Deliver training per approved curriculum
+
+4.3.4. Provide opportunities for questions and practice
+
+4.3.5. Assess comprehension through:
+   - Written knowledge test (minimum 80% passing score)
+   - Practical demonstration (mock administration)
+   - Review of videotaped administration (if applicable)
+   - Inter-rater reliability exercise (for ClinRO)
+
+4.3.6. Provide immediate feedback on performance
+
+4.3.7. Remediate and retest if assessment failed
+
+4.3.8. Issue training completion certificate
+
+### 4.4 Certification for Proprietary Measures
+
+4.4.1. For measures requiring copyright holder certification:
+   - Enroll personnel in approved certification program
+   - Complete all required training modules
+   - Pass certification examination
+   - Obtain certification certificate
+   - File certificate in personnel training record
+   - Track certification expiration date
+   - Schedule recertification before expiration
+
+4.4.2. For measures with gold standard training:
+   - Coordinate with measure developer
+   - Arrange for training (may be remote or in-person)
+   - Document completion and certification
+   - Maintain ongoing qualification requirements
+
+### 4.5 Training Documentation
+
+4.5.1. Training records shall include:
+   - Employee name and ID
+   - Training title and measure name
+   - Training date and duration
+   - Trainer name and qualifications
+   - Training materials version
+   - Assessment method and results
+   - Pass/fail determination
+   - Certification number (if applicable)
+   - Certification expiration date (if applicable)
+   - Signatures of trainee and trainer
+
+4.5.2. Use Form FRM-TRN-001: Administrator Training Record
+
+4.5.3. Maintain training records in central training database
+
+4.5.4. Training records accessible for regulatory inspection
+
+### 4.6 Competency Assessment
+
+4.6.1. Initial Competency:
+   - Demonstrated during training
+   - Supervised administration of first 3-5 assessments
+   - Review of first completed assessments for quality
+
+4.6.2. Ongoing Competency:
+   - Periodic inter-rater reliability checks (for ClinRO)
+   - Quality review of assessment data
+   - Observation of administration technique annually
+   - Refresher training as needed
+
+4.6.3. Document competency assessments in FRM-TRN-002
+
+4.6.4. Address deficiencies immediately:
+   - Provide additional training
+   - Increase supervision
+   - Reassess competency before independent work
+
+### 4.7 Retraining Requirements
+
+4.7.1. Retraining is required when:
+   - New measure version released
+   - Significant protocol changes affecting administration
+   - Performance deficiencies identified
+   - Extended absence from assessment activities (>12 months)
+   - Certification expires
+   - Measure administration procedures updated
+   - Quality issues identified in audit or data review
+
+4.7.2. Document retraining using same process as initial training
+
+4.7.3. Update training database and notify study teams
+
+### 4.8 New Personnel Orientation
+
+4.8.1. All new personnel shall complete:
+   1. Organization orientation
+   2. Quality system overview
+   3. Research ethics and GCP training
+   4. General outcome assessment training
+   5. Specific measure training for assigned studies
+   6. SOP read and understand for:
+      - SOP-ADM-001: Measure Administration
+      - SOP-DM-001: Data Management
+      - Study-specific protocols
+
+4.8.2. New personnel checklist completed and filed
+
+4.8.3. No independent measure administration until all training complete
+
+### 4.9 Specialized Training
+
+4.9.1. ClinRO Rater Training:
+   - Clinical credentials verification
+   - Detailed review of rating scales and anchors
+   - Practice with standardized case vignettes
+   - Inter-rater reliability establishment
+   - Ongoing drift prevention through regular calibration
+
+4.9.2. PerfO Administrator Training:
+   - Safety procedures
+   - Equipment operation and calibration
+   - Standardized instructions and demonstration
+   - Objective measurement techniques
+   - Emergency procedures
+
+4.9.3. Translation Study Personnel:
+   - Translation methodology (ISPOR guidelines)
+   - Cognitive debriefing techniques
+   - Cultural sensitivity
+   - Qualitative data collection
+   - See SOP-TRN-001
+
+4.9.4. Validation Study Personnel:
+   - Psychometric concepts
+   - Validation study protocols
+   - Statistical analysis plan familiarity
+   - Data collection procedures
+   - See SOP-VAL-001
+
+## 5. Training Records Retention
+
+5.1. Training records maintained for duration of personnel employment
+
+5.2. Records retained minimum 3 years after personnel departure
+
+5.3. Study-specific training records retained with study documentation per protocol requirements
+
+5.4. Records available for regulatory inspection and audit
+
+5.5. Electronic records maintained per 21 CFR Part 11 requirements
+
+## 6. Training Effectiveness Review
+
+6.1. Annual review of training program effectiveness:
+   - Training completion rates
+   - Assessment pass rates
+   - Competency assessment results
+   - Data quality metrics
+   - Audit findings related to training
+
+6.2. Update training materials based on:
+   - New regulatory guidance
+   - Measure updates
+   - Identified training gaps
+   - Audit findings
+   - Technological changes (e.g., eCOA platforms)
+
+## 7. Related Documents
+
+- FRM-TRN-001: Administrator Training Record
+- FRM-TRN-002: Competency Assessment Form
+- FRM-TRN-003: Training Effectiveness Review
+- SOP-ADM-001: Clinical Outcome Measure Administration
+- SOP-LIC-001: License Management
+- SOP-TRN-001: Translation and Linguistic Validation
+- SOP-VAL-001: Psychometric Validation
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Licensing/SOP-LIC-001-License-Management.md

@@ -0,0 +1,189 @@
+# Standard Operating Procedure: License Management for Proprietary Outcome Measures
+
+| Document ID | SOP-LIC-001 |
+|-------------|---------|
+| Title | License Management for Proprietary Outcome Measures |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Management |
+
+---
+
+## 1. Purpose
+
+This procedure establishes requirements for identifying, obtaining, tracking, and maintaining licenses for proprietary clinical outcome measures used in research studies and clinical programs.
+
+## 2. Scope
+
+This procedure applies to all proprietary outcome measures requiring licenses or permissions, including:
+- Patient-Reported Outcomes (PROs)
+- Clinician-Reported Outcomes (ClinROs)
+- Observer-Reported Outcomes (ObsROs)
+- Performance Outcomes (PerfOs)
+
+This includes both paper-based and electronic (eCOA) implementations.
+
+## 3. Responsibilities
+
+### 3.1 Quality Manager
+- Maintain master list of all licensed measures
+- Track license renewal dates
+- Ensure compliance with license terms
+- Coordinate with copyright holders
+
+### 3.2 Principal Investigator/Project Lead
+- Identify measure licensing requirements during study planning
+- Ensure appropriate licenses are obtained before study initiation
+- Notify Quality Manager of new measures requiring licenses
+- Ensure study team compliance with license terms
+
+### 3.3 Regulatory Affairs
+- Review licenses for regulatory submission requirements
+- Maintain copies of licenses in regulatory files
+- Coordinate permissions for protocol submissions
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Copyright Holder | The individual or organization that owns the intellectual property rights to the measure |
+| License Agreement | A legal agreement granting permission to use a copyrighted measure under specified terms |
+| Royalty | A fee paid to the copyright holder for commercial use of a measure |
+| Attribution | Required citation or acknowledgment of the measure developer and copyright holder |
+
+## 5. Procedure
+
+### 5.1 Identifying Licensing Requirements
+
+5.1.1. During measure selection, research whether the measure is:
+   - Public domain (no license required)
+   - Open access with attribution requirements
+   - Proprietary requiring paid license
+   - Available through special permission only
+
+5.1.2. Document the copyright status in Form FRM-LIC-001 (License Requirements Checklist)
+
+5.1.3. For proprietary measures, identify:
+   - Copyright holder and contact information
+   - Available license types (academic, commercial, per-study, unlimited)
+   - Costs and payment terms
+   - Restrictions on use, modification, or translation
+   - Requirements for reporting results
+
+### 5.2 Obtaining Licenses
+
+5.2.1. Contact copyright holder at least 8 weeks before planned measure use
+
+5.2.2. Complete license application providing:
+   - Study title and protocol number
+   - Number of participants
+   - Study sites and locations
+   - Intended use (research, clinical, commercial)
+   - Paper vs electronic administration
+   - Translation requirements
+
+5.2.3. Review license agreement for:
+   - Scope of use permissions
+   - Duration and renewal terms
+   - Costs and payment schedule
+   - Restrictions on modifications or translations
+   - Requirements for result reporting or publication acknowledgment
+   - Indemnification and liability provisions
+
+5.2.4. Obtain institutional legal review if required
+
+5.2.5. Execute license agreement and submit payment
+
+5.2.6. File executed license in License Tracking System and project files
+
+### 5.3 Tracking Active Licenses
+
+5.3.1. Maintain License Tracking Database (Form FRM-LIC-002) containing:
+   - Measure name and version
+   - Copyright holder
+   - License type and number
+   - Execution date and expiration date
+   - Covered projects/studies
+   - Cost and payment status
+   - Key terms and restrictions
+
+5.3.2. Set calendar reminders for:
+   - 90 days before license expiration
+   - 30 days before license expiration
+   - License expiration date
+
+### 5.4 License Renewals
+
+5.4.1. At 90 days before expiration, assess continued need for measure
+
+5.4.2. If renewal needed, initiate renewal process:
+   - Contact copyright holder
+   - Update project information
+   - Review any changes to license terms
+   - Submit renewal payment
+   - Update License Tracking Database
+
+5.4.3. If measure no longer needed:
+   - Document discontinuation date
+   - Ensure compliance with any post-termination obligations
+   - Archive license documentation
+
+### 5.5 Compliance Monitoring
+
+5.5.1. Quarterly review of License Tracking Database:
+   - Verify all active measures have current licenses
+   - Check upcoming renewals
+   - Confirm payment status
+   - Review compliance with license terms
+
+5.5.2. Investigate any identified issues:
+   - Expired licenses
+   - Measures used without licenses
+   - Uses exceeding license scope
+   - Missing payment records
+
+5.5.3. Document corrective actions taken
+
+### 5.6 Special Considerations
+
+#### 5.6.1 Electronic Administration (eCOA)
+- Confirm license permits electronic implementation
+- Provide eCOA platform specifications to copyright holder if required
+- Obtain approval for any necessary format adaptations
+- Document equivalence testing between paper and electronic versions
+
+#### 5.6.2 Translations
+- Confirm whether translations are included in base license
+- Obtain linguistic validation certificates from copyright holder
+- Follow copyright holder's translation procedures if specified
+- See SOP-TRN-001 for translation requirements
+
+#### 5.6.3 Commercial Use
+- Clearly identify commercial vs academic use
+- Ensure appropriate commercial license type
+- Document royalty calculation and payment terms
+- Maintain records for financial audits
+
+## 6. Related Documents
+
+- FRM-LIC-001: License Requirements Checklist
+- FRM-LIC-002: License Tracking Database
+- FRM-LIC-003: License Renewal Request Form
+- SOP-TRN-001: Translation and Linguistic Validation
+- SOP-VAL-001: Measure Selection and Validation
+
+## 7. References
+
+- U.S. Copyright Law (17 U.S.C.)
+- Intellectual property policies of individual measure developers
+- Institutional intellectual property and contract policies
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Translation/SOP-TRN-001-Translation-Linguistic-Validation.md

@@ -0,0 +1,333 @@
+# Standard Operating Procedure: Translation and Linguistic Validation of Clinical Outcome Measures
+
+| Document ID | SOP-TRN-001 |
+|-------------|---------|
+| Title | Translation and Linguistic Validation of Clinical Outcome Measures |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Outcomes Research |
+
+---
+
+## 1. Purpose
+
+This procedure establishes requirements for translating and linguistically validating clinical outcome measures to ensure conceptual equivalence across languages and cultures while maintaining psychometric properties.
+
+## 2. Scope
+
+This procedure applies to:
+- Translation of validated outcome measures into new languages
+- Linguistic validation of existing translations
+- Cultural adaptation for different regions
+- All measure types (PRO, ClinRO, ObsRO, PerfO)
+
+## 3. Responsibilities
+
+### 3.1 Translation Project Manager
+- Oversee translation process
+- Select and manage translation vendors
+- Coordinate with copyright holders
+- Ensure adherence to ISPOR guidelines
+- Maintain translation documentation
+
+### 3.2 In-Country Coordinator
+- Recruit local translators and reviewers
+- Arrange cognitive debriefing sessions
+- Provide cultural context and guidance
+- Review translations for local appropriateness
+
+### 3.3 Quality Manager
+- Review translation methodology
+- Ensure documentation completeness
+- Verify copyright permissions
+- Approve final translated versions
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Source Language | The original language of the measure (typically English) |
+| Target Language | The language into which the measure is being translated |
+| Forward Translation | Translation from source to target language |
+| Backward Translation | Translation from target language back to source language |
+| Reconciliation | Process of resolving discrepancies between translations |
+| Cognitive Debriefing | Qualitative interviews with target population to assess comprehension |
+| Linguistic Validation | Process of ensuring translation maintains conceptual equivalence |
+| Conceptual Equivalence | Same meaning and relevance across languages and cultures |
+
+## 5. Procedure
+
+### 5.1 Pre-Translation Activities
+
+5.1.1. Verify translation rights:
+   - Check license agreement for translation permissions
+   - Contact copyright holder for authorization
+   - Determine if official translations already exist
+   - Document translation approval in FRM-TRN-001
+
+5.1.2. Assess target country/region:
+   - Identify target language and dialect
+   - Consider cultural differences affecting concepts
+   - Determine literacy level of target population
+   - Identify any regional variations needed
+
+5.1.3. Obtain source materials:
+   - Current version of source measure
+   - Administration instructions
+   - Conceptual framework and item intent
+   - Previous translation memory if available
+   - Validation data for reference
+
+5.1.4. Select translation methodology:
+   - Standard ISPOR methodology (most common)
+   - Copyright holder's proprietary process if required
+   - Other recognized methods (e.g., EORTC, WHO)
+
+5.1.5. Assemble translation team:
+   - Forward translators (2 required)
+   - Backward translator (1 required)
+   - In-country reviewer
+   - Native speakers of both languages
+   - Healthcare/clinical expertise preferred
+
+### 5.2 Forward Translation
+
+5.2.1. Conduct independent forward translations:
+   - Two translators work independently
+   - Native speakers of target language
+   - Fluent in source language
+   - One "informed" (aware of measure purpose)
+   - One "uninformed" (naive to measure concepts)
+
+5.2.2. Forward translation guidelines:
+   - Aim for conceptual rather than literal translation
+   - Maintain level of language (lay vs technical)
+   - Preserve recall period and response options
+   - Note any translation challenges or ambiguities
+   - Document rationale for translation choices
+
+5.2.3. Document forward translations in FRM-TRN-002:
+   - Original item
+   - Translator 1 version
+   - Translator 2 version
+   - Translator notes and rationale
+
+### 5.3 Reconciliation of Forward Translations
+
+5.3.1. Convene reconciliation meeting:
+   - Both forward translators
+   - In-country reviewer
+   - Project manager (may be remote)
+
+5.3.2. Review each item systematically:
+   - Compare translation versions
+   - Discuss differences and rationale
+   - Consider cultural appropriateness
+   - Select preferred translation or create synthesis
+   - Reach consensus on single forward translation
+
+5.3.3. Document reconciliation:
+   - Final reconciled translation
+   - Rationale for choices made
+   - Unresolved issues for further review
+   - Record in FRM-TRN-002
+
+### 5.4 Backward Translation
+
+5.4.1. Conduct independent backward translation:
+   - Translator different from forward translators
+   - Native speaker of source language
+   - Fluent in target language
+   - "Uninformed" - not previously exposed to measure
+
+5.4.2. Translate reconciled version back to source language:
+   - Translate without seeing original source version
+   - Note any items difficult to translate back
+   - Provide literal translation
+   - Document in FRM-TRN-003
+
+5.4.3. Compare backward translation to original:
+   - Identify discrepancies
+   - Assess whether differences indicate translation problems
+   - Consider whether adjustments needed
+   - Minor wording differences acceptable if concept maintained
+
+### 5.5 Harmonization Review
+
+5.5.1. Conduct harmonization meeting:
+   - Translation team
+   - Project manager
+   - Clinical/outcomes expert
+   - Copyright holder representative if required
+
+5.5.2. Review backward translation comparison:
+   - Identify items with poor backward translation
+   - Discuss whether forward translation needs revision
+   - Consider alternative translations
+   - Update forward translation as needed
+
+5.5.3. Review across measure:
+   - Ensure consistent terminology throughout
+   - Check consistency of instructions and response options
+   - Verify formatting and layout match original
+   - Finalize translated version
+
+5.5.4. Document harmonization decisions in FRM-TRN-004
+
+### 5.6 Cognitive Debriefing
+
+5.6.1. Prepare cognitive debriefing protocol:
+   - Semi-structured interview guide
+   - Probes for comprehension and interpretation
+   - Questions about acceptability and relevance
+   - Typically 5-8 participants from target population
+
+5.6.2. Recruit appropriate participants:
+   - Representative of intended respondent population
+   - Native speakers of target language
+   - Range of ages, education levels, disease severity
+   - Geographic diversity if regional dialects exist
+
+5.6.3. Conduct cognitive debriefing interviews:
+   - Participant completes measure
+   - Interview about specific items:
+     * "What does this question mean to you?"
+     * "How did you decide on your answer?"
+     * "Is anything confusing or difficult to understand?"
+     * "Are any words or phrases unclear?"
+   - Probe problematic items in depth
+   - Document participant feedback
+
+5.6.4. Analyze cognitive debriefing results:
+   - Identify items with comprehension problems
+   - Determine whether issues are widespread or isolated
+   - Assess whether revisions needed
+   - Document in FRM-TRN-005
+
+### 5.7 Translation Revision (if needed)
+
+5.7.1. If cognitive debriefing identifies problems:
+   - Convene translation team
+   - Develop alternative translations for problematic items
+   - Consider cultural adaptation if needed
+   - Document rationale for revisions
+
+5.7.2. Conduct additional cognitive debriefing:
+   - Test revised items with new participants
+   - Continue until no significant issues identified
+   - Typically 5 participants per iteration sufficient
+
+### 5.8 Proofreading and Finalization
+
+5.8.1. Independent proofreading:
+   - Native speaker not involved in translation
+   - Check spelling, grammar, punctuation
+   - Verify consistency throughout
+   - Compare to source for formatting
+
+5.8.2. Format final translation:
+   - Match layout of original measure
+   - Ensure readability (font size, spacing)
+   - Include all instructions and response options
+   - Add translation identification (language, version, date)
+
+5.8.3. Create final translation package:
+   - Translated measure
+   - Administration instructions (translated)
+   - Scoring instructions (if publicly available)
+   - Translation certificate
+   - Linguistic validation report
+
+### 5.9 Copyright Holder Review (if required)
+
+5.9.1. Submit translation for approval:
+   - Final translated measure
+   - Translation methodology documentation
+   - Linguistic validation report summary
+   - Cognitive debriefing results
+
+5.9.2. Address any copyright holder feedback:
+   - Make required revisions
+   - Document changes and rationale
+   - Obtain final approval
+
+5.9.3. File approval in license documentation
+
+### 5.10 Translation Documentation
+
+5.10.1. Compile linguistic validation report:
+   - Translation methodology used
+   - Team qualifications
+   - Forward and backward translation results
+   - Cognitive debriefing findings
+   - Revisions made and rationale
+   - Conclusions regarding conceptual equivalence
+
+5.10.2. Create translation certificate including:
+   - Source and target languages
+   - Measure name and version
+   - Translation completion date
+   - Certification that ISPOR guidelines followed
+   - Signatures of translation team lead and project manager
+
+5.10.3. Archive all translation documentation:
+   - All translation versions
+   - Meeting notes and reconciliation records
+   - Cognitive debriefing transcripts and summaries
+   - Linguistic validation report
+   - Copyright holder correspondence
+   - File in Translation Database (FRM-TRN-006)
+
+### 5.11 Cultural Adaptation
+
+5.11.1. When cultural adaptation needed beyond translation:
+   - Identify culture-specific concepts requiring adaptation
+   - Consult with local clinical and cultural experts
+   - Modify items while maintaining conceptual equivalence
+   - Consider alternative examples or phrases
+   - Document all adaptations and justification
+
+5.11.2. For substantial cultural adaptations:
+   - Consider conducting psychometric validation
+   - May require copyright holder approval
+   - May result in "culturally adapted version" designation
+
+### 5.12 Electronic Format Considerations
+
+5.12.1. For eCOA implementations:
+   - Verify text fits within screen space
+   - Check for right-to-left language considerations
+   - Test all navigation and response capture
+   - Ensure proper character encoding
+   - Validate against paper version
+
+5.12.2. Document any format adaptations required
+
+## 6. Related Documents
+
+- FRM-TRN-001: Translation Authorization Form
+- FRM-TRN-002: Forward Translation Documentation
+- FRM-TRN-003: Backward Translation Documentation
+- FRM-TRN-004: Harmonization Meeting Notes
+- FRM-TRN-005: Cognitive Debriefing Summary
+- FRM-TRN-006: Translation Database
+- FRM-TRN-007: Translation Certificate Template
+- SOP-LIC-001: License Management
+- SOP-VAL-002: Cross-Cultural Validation
+
+## 7. References
+
+- Wild D, et al. (2005). Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health, 8(2), 94-104
+- Wild D, et al. (2009). Multinational trials - recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report
+- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
+- Acquadro C, et al. (2008). Literature Review of Methods to Translate Health-Related Quality of Life Questionnaires for Use in Multinational Clinical Trials. Value in Health, 11(3), 509-521
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Validation/SOP-VAL-001-Psychometric-Validation.md

@@ -0,0 +1,259 @@
+# Standard Operating Procedure: Psychometric Validation of Clinical Outcome Measures
+
+| Document ID | SOP-VAL-001 |
+|-------------|---------|
+| Title | Psychometric Validation of Clinical Outcome Measures |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Outcomes Research |
+
+---
+
+## 1. Purpose
+
+This procedure establishes requirements for conducting psychometric validation studies of clinical outcome measures to ensure they demonstrate appropriate measurement properties for their intended use.
+
+## 2. Scope
+
+This procedure applies to:
+- New outcome measure development
+- Validation of existing measures in new populations
+- Adaptation of measures for new contexts or modes of administration
+- All outcome measure types (PRO, ClinRO, ObsRO, PerfO)
+
+## 3. Responsibilities
+
+### 3.1 Principal Investigator/Measure Developer
+- Design validation study protocol
+- Ensure appropriate statistical expertise
+- Review and interpret validation results
+- Document validation evidence
+
+### 3.2 Biostatistician
+- Develop statistical analysis plan
+- Conduct psychometric analyses
+- Generate validation reports
+- Advise on sample size and methodology
+
+### 3.3 Quality Manager
+- Review validation protocols for regulatory compliance
+- Maintain validation documentation
+- Track validation status of all measures
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Reliability | The degree to which a measure is free from measurement error |
+| Internal Consistency | The extent to which items within a scale measure the same construct (Cronbach's alpha) |
+| Test-Retest Reliability | Consistency of scores when measure is administered to the same individuals at different times |
+| Inter-Rater Reliability | Agreement between different raters/observers (for ClinRO, ObsRO) |
+| Validity | The degree to which a measure assesses what it purports to measure |
+| Content Validity | Evidence that measure items represent all aspects of the construct |
+| Construct Validity | Evidence that measure relates to other measures as theoretically expected |
+| Criterion Validity | Agreement between measure and a gold standard |
+| Responsiveness | Ability to detect meaningful change over time |
+| MCID | Minimal Clinically Important Difference - smallest change considered important |
+| Floor/Ceiling Effects | Clustering of scores at bottom or top of scale, limiting ability to detect change |
+
+## 5. Procedure
+
+### 5.1 Validation Study Planning
+
+5.1.1. Define validation objectives:
+   - Target population
+   - Intended use and context
+   - Mode of administration (paper, electronic, interview)
+   - Key measurement properties to evaluate
+
+5.1.2. Develop validation protocol including:
+   - Background and rationale
+   - Study design and timeline
+   - Participant eligibility criteria
+   - Sample size justification
+   - Data collection procedures
+   - Statistical analysis plan
+   - Success criteria for validation
+
+5.1.3. Select comparison measures:
+   - Established measures of same construct (convergent validity)
+   - Measures of different constructs (discriminant validity)
+   - Clinical indicators or gold standards (criterion validity)
+
+5.1.4. Obtain necessary regulatory approvals (IRB, informed consent)
+
+5.1.5. Document validation plan in Form FRM-VAL-001
+
+### 5.2 Reliability Assessment
+
+#### 5.2.1 Internal Consistency Reliability
+
+5.2.1.1. Analyze baseline data from main study sample
+
+5.2.1.2. Calculate Cronbach's alpha for each scale/subscale
+
+5.2.1.3. Acceptance criteria:
+   - Alpha ≥ 0.70 for group comparisons
+   - Alpha ≥ 0.90 for individual decision-making
+   - Alpha < 0.95 (if higher, may indicate item redundancy)
+
+5.2.1.4. Examine item-total correlations (typically ≥ 0.30)
+
+5.2.1.5. Assess scale dimensionality using factor analysis
+
+#### 5.2.2 Test-Retest Reliability
+
+5.2.2.1. Administer measure twice to stable subsample
+
+5.2.2.2. Time interval: typically 2-14 days
+   - Short enough that true change is unlikely
+   - Long enough to prevent memory effects
+
+5.2.2.3. Calculate intraclass correlation coefficient (ICC)
+
+5.2.2.4. Acceptance criteria:
+   - ICC ≥ 0.70 for group comparisons
+   - ICC ≥ 0.90 for individual decision-making
+
+5.2.2.5. Calculate standard error of measurement (SEM)
+
+5.2.2.6. Generate Bland-Altman plots to assess agreement
+
+#### 5.2.3 Inter-Rater Reliability (for ClinRO, ObsRO)
+
+5.2.3.1. Have multiple raters assess same participants
+
+5.2.3.2. Calculate ICC or weighted kappa as appropriate
+
+5.2.3.3. Acceptance criteria:
+   - ICC or kappa ≥ 0.70
+
+5.2.3.4. Identify sources of disagreement for training improvement
+
+### 5.3 Validity Assessment
+
+#### 5.3.1 Content Validity
+
+5.3.1.1. Conduct qualitative research with target population:
+   - Concept elicitation interviews
+   - Cognitive debriefing of items
+   - Assessment of comprehensibility and relevance
+
+5.3.1.2. Obtain expert panel review:
+   - Clinical experts
+   - Psychometricians
+   - Patient representatives
+
+5.3.1.3. Document evidence in content validity report
+
+5.3.1.4. For FDA submissions, follow FDA PRO Guidance requirements
+
+#### 5.3.2 Construct Validity
+
+5.3.2.1. Convergent validity:
+   - Correlate with established measures of same construct
+   - Expected correlation: typically r ≥ 0.50-0.70
+
+5.3.2.2. Discriminant validity:
+   - Correlate with measures of different constructs
+   - Expected correlation: typically r < 0.30
+
+5.3.2.3. Known-groups validity:
+   - Compare scores across groups expected to differ
+   - Use appropriate statistical tests (t-test, ANOVA)
+   - Calculate effect sizes (Cohen's d, eta-squared)
+
+5.3.2.4. Factorial validity:
+   - Conduct confirmatory factor analysis (CFA)
+   - Assess model fit (CFI > 0.90, RMSEA < 0.08, SRMR < 0.08)
+
+#### 5.3.3 Criterion Validity
+
+5.3.3.1. If gold standard exists, calculate:
+   - Sensitivity and specificity
+   - Positive and negative predictive values
+   - ROC curves and AUC
+
+### 5.4 Responsiveness Assessment
+
+5.4.1. Collect data at baseline and follow-up from participants expected to change
+
+5.4.2. Calculate change scores
+
+5.4.3. Assess responsiveness using:
+   - Effect sizes (Cohen's d, standardized response mean)
+   - Correlation with external indicators of change
+   - Receiver operating characteristic (ROC) analysis
+
+5.4.4. Determine Minimal Clinically Important Difference (MCID):
+   - Anchor-based methods (correlation with patient global ratings)
+   - Distribution-based methods (0.5 SD, 1 SEM)
+   - Multiple methods recommended
+
+### 5.5 Interpretability Assessment
+
+5.5.1. Assess score distribution:
+   - Floor effects: >15% scoring at minimum
+   - Ceiling effects: >15% scoring at maximum
+   - Skewness and kurtosis
+
+5.5.2. Develop score interpretation guidelines:
+   - Clinical cutoff scores
+   - Severity categories
+   - Normative data (if appropriate)
+
+5.5.3. Document MCID and other interpretability anchors
+
+### 5.6 Validation Report
+
+5.6.1. Prepare comprehensive validation report including:
+   - Study objectives and methods
+   - Participant characteristics
+   - All psychometric analyses results
+   - Tables and figures
+   - Discussion of strengths and limitations
+   - Conclusions and recommendations for use
+
+5.6.2. File validation report as Form FRM-VAL-002
+
+5.6.3. Update measure status in Validation Tracking Database
+
+5.6.4. For regulatory submissions, prepare according to FDA guidance
+
+### 5.7 Ongoing Validation Activities
+
+5.7.1. Plan for continued evidence generation:
+   - Validation in additional populations
+   - Assessment in different contexts or settings
+   - Cross-cultural validation
+   - Longitudinal measurement invariance
+
+5.7.2. Monitor published validation evidence for measures in use
+
+5.7.3. Review and update validation status annually
+
+## 6. Related Documents
+
+- FRM-VAL-001: Validation Study Protocol Template
+- FRM-VAL-002: Psychometric Validation Report Template
+- FRM-VAL-003: Validation Tracking Database
+- SOP-DM-001: Data Management for Validation Studies
+- SOP-LIC-001: License Management
+
+## 7. References
+
+- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
+- Mokkink LB, et al. (2010). The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments. Quality of Life Research, 19(4), 539-549
+- Reeve BB, et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22(8), 1889-1905
+- Streiner DL, Norman GR, Cairney J (2015). Health Measurement Scales: A Practical Guide to Their Development and Use (5th ed.). Oxford University Press
+- DeVellis RF (2017). Scale Development: Theory and Applications (4th ed.). SAGE Publications
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

Templates/SOP-Template.md

@@ -0,0 +1,69 @@
+# Standard Operating Procedure: [Title]
+
+| Document ID | SOP-XXX |
+|-------------|---------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[State the purpose of this procedure]
+
+## 2. Scope
+
+[Define the scope and applicability - which measures, which studies, which personnel]
+
+## 3. Responsibilities
+
+### 3.1 [Role 1]
+- [Responsibility]
+- [Responsibility]
+
+### 3.2 [Role 2]
+- [Responsibility]
+- [Responsibility]
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| PRO | Patient-Reported Outcome - A measurement based on a report that comes directly from the patient |
+| ClinRO | Clinician-Reported Outcome - A measurement based on a report from a trained healthcare professional |
+| ObsRO | Observer-Reported Outcome - A measurement based on observation by someone other than the patient or healthcare professional |
+| PerfO | Performance Outcome - A measurement based on a standardized task actively undertaken by a patient |
+| MCID | Minimal Clinically Important Difference - The smallest change in outcome that patients perceive as beneficial |
+
+## 5. Procedure
+
+### 5.1 [Section Title]
+
+[Procedure steps]
+
+### 5.2 [Section Title]
+
+[Procedure steps]
+
+## 6. Related Documents
+
+- [List related procedures, forms, validation reports, etc.]
+
+## 7. References
+
+- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
+- FDA-NIH Biomarker Working Group (2016). BEST (Biomarkers, EndpointS, and other Tools) Resource
+- ISPOR Task Force (2005). Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures
+- [Additional relevant standards, regulations, publications]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

Work Instructions/WI-001-Template.md

@@ -0,0 +1,104 @@
+# Work Instruction: [Title]
+
+| Document ID | WI-001 |
+|-------------|--------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[Describe the purpose of this work instruction - e.g., administration of specific measure, scoring procedure, translation protocol]
+
+## 2. Scope
+
+[Define what activities this instruction covers - specific measures, populations, settings]
+
+## 3. Prerequisites
+
+### 3.1 Training Requirements
+- [Required training courses/certifications]
+- [Measure-specific training completion]
+- [Administrator qualification criteria]
+
+### 3.2 Licensing/Permissions
+- [Required licenses or permissions]
+- [Copyright acknowledgment]
+- [Usage restrictions]
+
+## 4. Equipment/Materials Required
+
+| Item | Specification | Notes |
+|------|---------------|-------|
+| [Measure instrument] | [Version/Form] | [Paper or electronic] |
+| [Scoring tools] | [Software/Calculator] | [If applicable] |
+| | | |
+
+## 5. Procedure
+
+### Step 1: [Preparation]
+[Detailed instructions for setup, environment, respondent preparation]
+
+### Step 2: [Administration]
+[Step-by-step administration instructions]
+- Standardized instructions to be read verbatim
+- Response options and recall period
+- Handling respondent questions
+- Time limits (if applicable)
+
+### Step 3: [Scoring]
+[Scoring algorithm and procedures]
+- Calculation methods
+- Handling missing data
+- Reverse-scored items (if applicable)
+- Subscale and total score computation
+
+### Step 4: [Interpretation]
+[How to interpret scores]
+- Reference values or normative data
+- Clinical cutoffs or thresholds
+- Minimal clinically important difference (MCID)
+
+### Step 5: [Documentation]
+[Required documentation and records]
+
+## 6. Quality Control
+
+- [Verification steps]
+- [Common errors to avoid]
+- [Data quality checks]
+
+## 7. Acceptance Criteria
+
+[Define what constitutes successful completion]
+- Completeness criteria
+- Data quality standards
+- Acceptable missing data thresholds
+
+## 8. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| [Completed measure] | [System/location] | [Duration] |
+| [Scoring worksheets] | [System/location] | [Duration] |
+| [Training documentation] | [System/location] | [Duration] |
+
+## 9. References
+
+- [Measure developer's manual]
+- [Validation publications]
+- [Related SOPs]
+- [License agreement]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |