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

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]