Investigators
Kevin Shelburne
Contact info (email)
kevin.shelburne@du.edu
1. Define context(s)
aid in FDA decision making
aid in clinical decision making
aid in clinical trial design
identify/explore new therapies
Current Conformance Level / Target Conformance Level
Adequate
Primary goal of the model/tool/database
Simulation of human activity for understanding normal musculoskeletal function, pathology, and treatment.
Biological domain of the model
Human musculoskeletal system
Structure(s) of interest in the model
cartilage, ligament, muscle, tendon, bone, fat
Spatial scales included in the model
mm (e.g. cartilage) to m (e.g. whole-body) to human cohorts
Time scales included in the model
millisecond to minutes
2. Data for building and validating the model
| Data for building the model | Published? | Private? | How is credibility checked? | Current Conformance Level / Target Conformance Level |
|---|---|---|---|---|
| in vitro (primary cells cell, lines, etc.) | ||||
| ex vivo (excised tissues) | Y | Y | Adequate | |
| in vivo pre-clinical (lower-level organism or small animal) | ||||
| in vivo pre-clinical (large animal) | ||||
| Human subjects/clinical | y | Y | Adequate | |
| Other: ________________________ |
| Data for validating the model | Published? | Private? | How is credibility checked? | Current Conformance Level / Target Conformance Level |
|---|---|---|---|---|
| in vitro (primary cells cell, lines, etc.) | ||||
| ex vivo (excised tissues) | ||||
| in vivo pre-clinical (lower-level organism or small animal) | ||||
| in vivo pre-clinical (large animal) | ||||
| Human subjects/clinical | ||||
| Other: ________________________ |
3. Validate within context(s)
| Who does it? | When does it happen? | How is it done? | Current Conformance Level / Target Conformance Level | |
|---|---|---|---|---|
| Verification | PI and staff | |||
| Validation | PI and outside reviewers | Year 3 and 4 | recreate models and simulations to match in vivo data | Adequate |
| Uncertainty quantification | ||||
| Sensitivity analysis | ||||
| Other:__________ | ||||
| Additional Comments |
4. Limitations
| Disclaimer statement (explain key limitations) | Who needs to know about this disclaimer? | How is this disclaimer shared with that audience? | Current Conformance Level / Target Conformance Level |
|---|---|---|---|
| lower extremity musculoskeletal only | users and evaluators | publication | adequate |
5. Version control
| Current Conformance Level / Target Conformance Level |
|---|
| Partial |
| Naming Conventions? | Repository? | Code Review? | |
|---|---|---|---|
| individual modeler | TBD | ||
| within the lab | |||
| collaborators |
6. Documentation
| Current Conformance Level / Target Conformance Level | |
|---|---|
| Code commented? | Adequate |
| Scope and intended use described? | Adequate |
| User’s guide? | TBD |
| Developer’s guide? |
7. Dissemination
| Current Conformance Level / Target Conformance Level |
|---|
| Adequate |
| Target Audience(s): | “Inner circle” | Scientific community | Public |
|---|---|---|---|
| Simulations | SimTK.org, Digital Commons | ||
| Models | SimTK.org, Digital Commons | ||
| Software | SimTK.org, Digital Commons | ||
| Results | publication | ||
| Implications of results | publication |
8. Independent reviews
| Current Conformance Level / Target Conformance Level |
|---|
| TBD |
| Reviewer(s) name & affiliation: | |
|---|---|
| When was review performed? | |
| How was review performed and outcomes of the review? |
9. Test competing implementations
| Current Conformance Level / Target Conformance Level |
|---|
| TBD |
| Yes or No (briefly summarize) | |
|---|---|
| Were competing implementations tested? | |
| Did this lead to model refinement or improvement? |
10. Conform to standards
| Current Conformance Level / Target Conformance Level |
|---|
| Partial |
| Yes or No (briefly summarize) | |
|---|---|
| Are there operating procedures, guidelines, or standards for this type of multiscale modeling? | Partially and in process of development |
| How do your modeling efforts conform? |