146 lines
3.7 KiB
Markdown
146 lines
3.7 KiB
Markdown
# License Requirements Checklist
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| Form ID | FRM-LIC-001 |
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|---------|-------------|
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| Form Title | License Requirements Checklist |
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| Version | 1.0 |
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| Effective Date | [DATE] |
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---
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## Measure Information
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| Field | Information |
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|-------|-------------|
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| Measure Name | |
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| Version/Form | |
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| Measure Type | ☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO |
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| Purpose/Study | |
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| Protocol Number | |
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## Copyright Status
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| Field | Response |
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|-------|----------|
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| Copyright Holder | |
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| Copyright Holder Contact | |
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| Website | |
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### Copyright Classification
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☐ **Public Domain**
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- No copyright restrictions
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- Free to use without permission
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- No license required
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☐ **Open Access with Attribution**
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- Free to use
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- Attribution required
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- Specific citation format: _____________________
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☐ **Proprietary - License Required**
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- Paid license required
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- License type needed: ☐ Academic ☐ Commercial ☐ Clinical
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- Proceed to License Requirements section
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☐ **Special Permission Required**
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- Must contact copyright holder for permission
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- Restrictions on use: _____________________
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## License Requirements (if applicable)
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### License Type Options
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| License Type | Cost | Terms | Notes |
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|--------------|------|-------|-------|
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| Single Study | | | |
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| Multi-Study | | | |
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| Institutional | | | |
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| Commercial | | | |
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### Scope of Use
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Number of Participants: _________
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Study Sites/Locations: _________________________________________
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Countries: ___________________________________________________
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Study Duration: From __________ to __________
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### Administration Mode
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☐ Paper-based
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☐ Electronic (eCOA)
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- Platform: _____________________
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- Additional fees for electronic use? ☐ Yes ☐ No
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### Translation Requirements
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Languages needed: _____________________________________________
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☐ Official translations available
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☐ New translation required (see SOP-TRN-001)
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☐ Translation included in license
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☐ Translation requires additional fee
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### Special Requirements/Restrictions
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☐ Training/certification required for administrators
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☐ Restrictions on modifications
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☐ Requirements for result reporting to copyright holder
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☐ Publication acknowledgment required
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☐ Royalty fees for commercial use
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Details: ________________________________________________________
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________________________________________________________________
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________________________________________________________________
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## Action Items
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| Action | Responsible | Target Date | Status |
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|--------|-------------|-------------|--------|
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| Contact copyright holder | | | |
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| Obtain license application | | | |
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| Complete application | | | |
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| Legal review | | | |
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| Obtain approval signatures | | | |
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| Submit payment | | | |
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| File executed license | | | |
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## Documentation Checklist
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☐ Copyright holder contact information verified
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☐ License application obtained
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☐ License terms reviewed
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☐ Legal review completed (if required)
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☐ Budget approved for license fees
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☐ License application submitted
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☐ License agreement received and executed
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☐ Payment processed
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☐ License filed in License Tracking Database (FRM-LIC-002)
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☐ Project team notified of license status
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## Notes/Additional Information
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________________________________________________________________
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________________________________________________________________
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________________________________________________________________
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________________________________________________________________
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---
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## Signatures
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| Completed By | | | |
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| Reviewed By | | | |
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---
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**Related Documents:**
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- SOP-LIC-001: License Management for Proprietary Outcome Measures
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- FRM-LIC-002: License Tracking Database
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- SOP-VAL-001: Measure Selection and Validation
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