Discussion on proposed change on MolecularBiomarker Definition

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Proposed Change on MolecularBiomarker Definition (row 52)

Original Definition

DEFINITION: An individual mutation that alone or together with other mutations contributes to a medical

conclusion.

EXAMPLE(S): L10I, K20R, M36I, A71V, V82T

OTHER NAME(S): Biological State

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. This suggestion is similar to the NIH Biomarkers Definitions Working Group definition.

Proposed Definition

DEFINITION: An individual mutation that alone or together with other mutations contributes to a medical

conclusion.

EXAMPLE(S): L10I, K20R, M36I, A71V, V82T <= SHOULD THESE BE CONSISTENT EXAMPLE SCENARIO USED ACROSS ALL

MOLECULAR BIOLOGY CLASSES???

OTHER NAME(S): Biological State

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. Should the two

definitions be harmonized?

Outstanding Questions

• CDISC PGx SMEs: Is the proposed change consistent with your original use case for MolecularBiomarker?
• 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

Please add your responses here...

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