Discussion on Proposed Change to MolecularBiomarkerGroup Definition

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Proposed Change to MolecularBiomarkerGroup Definition (row 53)

Original Definition

DEFINITION: A collection of molecular biomarkers that associates observed genetic mutations with medical conclusions.

EXAMPLE(S): Molecular Biomarker Group "L10I+K20R+M36I+A71V+V82T" links a set of mutations with the conclusion of drug resistance to the drug "lndinavir".

OTHER NAME(S):

NOTE(S):

Ballot Comment

A mutation is only one type of molecular biomarker. A molecular biomarker does not have to yield a medical-level conclusion.

Proposed Definition

DEFINITION: A collection of molecular biomarkers.

EXAMPLE(S): Molecular Biomarker Group "L10I+K20R+M36I+A71V+V82T" links a set of mutations with the conclusion of drug resistance to the drug "lndinavir".

OTHER NAME(S):

NOTE(S):

Proposed Disposition

Persuasive

Proposed Disposition Comment

Review proposed change with PGx SMEs to ensure change is consistent with their original use case for the concept. Also see disposition comments and recommendation on Gene item a few rows above.

Outstanding Questions

• CDISC PGx SMEs: Is the proposed change consistent with your original use case for MolecularBiomarkerGroup?
• Anyone: Can someone provide a comprehensive, realistic and meaningful set of example values that uses the same overall scenario across all classes in the Molecular Biology sub-domain?

Responses

Lauren Becnel: The proposed definition is much broader and better. See my comments on item 5 above.

Q from WENDY (TYPE: EX): Agreement on definition is good - will make that change if we don't need to circle back to PGx SMEs, but for examples, we need SME suggestions for additional examples if that's what Lauren is recommending.

DISCUSSION 20160223: CHANGE definition and leave example as is, circle back with Joyce on PGx-related comments as a whole

UPDATE DONE IN THE MODEL

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