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SOPs/Licensing/SOP-LIC-001-License-Management.md
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SOPs/Licensing/SOP-LIC-001-License-Management.md
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# Standard Operating Procedure: License Management for Proprietary Outcome Measures
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| Document ID | SOP-LIC-001 |
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|-------------|---------|
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| Title | License Management for Proprietary Outcome Measures |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Quality Management |
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---
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## 1. Purpose
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This procedure establishes requirements for identifying, obtaining, tracking, and maintaining licenses for proprietary clinical outcome measures used in research studies and clinical programs.
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## 2. Scope
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This procedure applies to all proprietary outcome measures requiring licenses or permissions, including:
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- Patient-Reported Outcomes (PROs)
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- Clinician-Reported Outcomes (ClinROs)
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- Observer-Reported Outcomes (ObsROs)
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- Performance Outcomes (PerfOs)
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This includes both paper-based and electronic (eCOA) implementations.
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## 3. Responsibilities
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### 3.1 Quality Manager
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- Maintain master list of all licensed measures
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- Track license renewal dates
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- Ensure compliance with license terms
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- Coordinate with copyright holders
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### 3.2 Principal Investigator/Project Lead
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- Identify measure licensing requirements during study planning
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- Ensure appropriate licenses are obtained before study initiation
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- Notify Quality Manager of new measures requiring licenses
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- Ensure study team compliance with license terms
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### 3.3 Regulatory Affairs
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- Review licenses for regulatory submission requirements
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- Maintain copies of licenses in regulatory files
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- Coordinate permissions for protocol submissions
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| Copyright Holder | The individual or organization that owns the intellectual property rights to the measure |
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| License Agreement | A legal agreement granting permission to use a copyrighted measure under specified terms |
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| Royalty | A fee paid to the copyright holder for commercial use of a measure |
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| Attribution | Required citation or acknowledgment of the measure developer and copyright holder |
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## 5. Procedure
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### 5.1 Identifying Licensing Requirements
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5.1.1. During measure selection, research whether the measure is:
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- Public domain (no license required)
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- Open access with attribution requirements
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- Proprietary requiring paid license
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- Available through special permission only
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5.1.2. Document the copyright status in Form FRM-LIC-001 (License Requirements Checklist)
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5.1.3. For proprietary measures, identify:
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- Copyright holder and contact information
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- Available license types (academic, commercial, per-study, unlimited)
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- Costs and payment terms
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- Restrictions on use, modification, or translation
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- Requirements for reporting results
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### 5.2 Obtaining Licenses
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5.2.1. Contact copyright holder at least 8 weeks before planned measure use
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5.2.2. Complete license application providing:
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- Study title and protocol number
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- Number of participants
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- Study sites and locations
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- Intended use (research, clinical, commercial)
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- Paper vs electronic administration
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- Translation requirements
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5.2.3. Review license agreement for:
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- Scope of use permissions
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- Duration and renewal terms
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- Costs and payment schedule
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- Restrictions on modifications or translations
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- Requirements for result reporting or publication acknowledgment
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- Indemnification and liability provisions
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5.2.4. Obtain institutional legal review if required
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5.2.5. Execute license agreement and submit payment
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5.2.6. File executed license in License Tracking System and project files
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### 5.3 Tracking Active Licenses
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5.3.1. Maintain License Tracking Database (Form FRM-LIC-002) containing:
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- Measure name and version
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- Copyright holder
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- License type and number
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- Execution date and expiration date
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- Covered projects/studies
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- Cost and payment status
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- Key terms and restrictions
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5.3.2. Set calendar reminders for:
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- 90 days before license expiration
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- 30 days before license expiration
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- License expiration date
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### 5.4 License Renewals
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5.4.1. At 90 days before expiration, assess continued need for measure
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5.4.2. If renewal needed, initiate renewal process:
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- Contact copyright holder
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- Update project information
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- Review any changes to license terms
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- Submit renewal payment
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- Update License Tracking Database
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5.4.3. If measure no longer needed:
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- Document discontinuation date
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- Ensure compliance with any post-termination obligations
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- Archive license documentation
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### 5.5 Compliance Monitoring
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5.5.1. Quarterly review of License Tracking Database:
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- Verify all active measures have current licenses
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- Check upcoming renewals
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- Confirm payment status
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- Review compliance with license terms
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5.5.2. Investigate any identified issues:
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- Expired licenses
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- Measures used without licenses
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- Uses exceeding license scope
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- Missing payment records
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5.5.3. Document corrective actions taken
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### 5.6 Special Considerations
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#### 5.6.1 Electronic Administration (eCOA)
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- Confirm license permits electronic implementation
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- Provide eCOA platform specifications to copyright holder if required
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- Obtain approval for any necessary format adaptations
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- Document equivalence testing between paper and electronic versions
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#### 5.6.2 Translations
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- Confirm whether translations are included in base license
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- Obtain linguistic validation certificates from copyright holder
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- Follow copyright holder's translation procedures if specified
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- See SOP-TRN-001 for translation requirements
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#### 5.6.3 Commercial Use
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- Clearly identify commercial vs academic use
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- Ensure appropriate commercial license type
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- Document royalty calculation and payment terms
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- Maintain records for financial audits
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## 6. Related Documents
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- FRM-LIC-001: License Requirements Checklist
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- FRM-LIC-002: License Tracking Database
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- FRM-LIC-003: License Renewal Request Form
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- SOP-TRN-001: Translation and Linguistic Validation
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- SOP-VAL-001: Measure Selection and Validation
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## 7. References
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- U.S. Copyright Law (17 U.S.C.)
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- Intellectual property policies of individual measure developers
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- Institutional intellectual property and contract policies
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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