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# 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] |

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# 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] |

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# 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] |

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# 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] |

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# 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] |

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# 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] |