# 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 |

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## 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

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## Revision History

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