# 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 |

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## 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

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## Revision History

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