2015-06-05 BRIDG WG (BART) Meeting Minutes

Attendees

 Ed Helton, NCI, co-chair

 Boris Brodsky, FDA

 Terry Hardin, Parexel

 Wendy Ver Hoef, Samvit Solutions

 Julie James, Blue Wave/Parexel

 Bob Milius, NMDP

 Roomi Nusrat, BioPartners

 Armando Oliva, FDA

 Jane Pollack, NMDP

 Lise Stevens, FDA

 Diane Wold, CDISC

Wendy presented an update of her presentation on empty classes. [uploaded]

Type codes vs name codes: Can collapse if no distinct associations, and classes can be represented as type codes. Want to have a consistent pattern with activities. Need to be careful when introducing name codes. In NCIt, may have a display name (CD), but the code is defined internally.

CellLine and MicrobiologicalCulture: Distinct semantics, may not be subsumed into CellCulture. E.g. MicrobiologicalCulture includes viruses, fungi and bacteria. E.g. of a difference between CellLine and CellCulture: Some cells can be removed from the body and live outside of it (CellLine) and some cannot.

Challenging to know how much science knowledge to put into the information model, and how much – into control terminology. Many levels of specialization (e.g. 5 levels for CellCulture). E.g. IDMP standard is separate from the substances that go into them (e.g. chemicals have a complex structure best captured through terminologies). Action item: Julie will provide examples of how terminologies and ontologies could be referenced from the model.

As we think about collapsing / expanding the classes, need to think of the use cases they were designed to support. May need to make a decision about which classes may need to stay based on supporting the overall user base. Some classes will have attributes added in the future (e.g. imaging), and thus should not be collapsed. FDA has expressed concern that BRIDG is no longer a DAM.

LS DAM was developed outside of BRIDG as a translational research model (not restricted to protocol- driven research). LS DAM had many BRIDG concepts already, so integration appeared useful. Also, pharma is working with pharmacogenetics, which overlaps with LS. LS DAM was developed top-down, while the rest of BRIDG was driven bottom-up; perhaps there is a way to tag the concepts not associated with specific use cases, to identify areas that may be deprecated in the future. E.g. in NMDP, Donor needs to be separate from Patient, but for FHIR this Donor is a kind of Patient.

For the next BRIDG WG BART meeting, it was recommended to continue the discussion of empty classes.