# Clinical Sign-off Checklist

**Date**: 2025-09-06
**Model**: UNETR MultiModal Baseline v1.0
**Dataset**: MSD Task01 BrainTumour

## Technical Validation

- [ ] **Model Training**
  - [ ] Training completed without errors
  - [ ] Convergence achieved
  - [ ] Model checkpoints saved
  - [ ] Training logs available

- [ ] **Performance Metrics**
  - [ ] Dice Score ≥ 0.80
  - [ ] Hausdorff 95 ≤ 5.0mm
  - [ ] Inference time ≤ 5.0s
  - [ ] Memory usage within limits

- [ ] **Code Quality**
  - [ ] Code review completed
  - [ ] Unit tests passing
  - [ ] Integration tests passing
  - [ ] Documentation complete

## Clinical Validation

- [ ] **Dataset Validation**
  - [ ] Training data quality verified
  - [ ] Validation set representative
  - [ ] Test set held-out properly
  - [ ] Data splits documented

- [ ] **Clinical Review**
  - [ ] Segmentations reviewed by expert
  - [ ] Clinical accuracy assessed
  - [ ] Edge cases identified
  - [ ] Failure modes documented

- [ ] **Safety Assessment**
  - [ ] Known limitations documented
  - [ ] Contraindications identified
  - [ ] Clinical workflow validated
  - [ ] User training completed

## Deployment Readiness

- [ ] **Infrastructure**
  - [ ] Production environment tested
  - [ ] API endpoints validated
  - [ ] GUI functionality verified
  - [ ] Monitoring in place

- [ ] **Integration**
  - [ ] PACS integration tested
  - [ ] 3D Slicer compatibility verified
  - [ ] Workflow integration complete
  - [ ] User acceptance testing done

- [ ] **Documentation**
  - [ ] User manual complete
  - [ ] Technical documentation ready
  - [ ] Training materials prepared
  - [ ] Support procedures defined

## Regulatory & Compliance

- [ ] **Quality Management**
  - [ ] QM system compliance verified
  - [ ] Risk management completed
  - [ ] Design controls followed
  - [ ] Validation protocol executed

- [ ] **Regulatory**
  - [ ] Regulatory strategy defined
  - [ ] Pre-submission completed (if applicable)
  - [ ] Submission prepared (if applicable)
  - [ ] Post-market surveillance planned

## Sign-off

### Technical Lead
**Name**: ________________  
**Date**: ________________  
**Signature**: ________________

### Clinical Lead
**Name**: ________________  
**Date**: ________________  
**Signature**: ________________

### Quality Assurance
**Name**: ________________  
**Date**: ________________  
**Signature**: ________________

### Regulatory Affairs
**Name**: ________________  
**Date**: ________________  
**Signature**: ________________

## Notes

_Use this section for any additional notes or conditions for sign-off._

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**Final Approval**: ________________  
**Date**: ________________  
**Version**: 1.0  
**Status**: CPU only: Minimal configuration Configuration Ready
