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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] |