# 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 |

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## 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

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |