measure-repository/SOPs/Licensing/SOP-LIC-001-License-Management.md

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]