Out of Scope for HL7 Sep 2018 Ballot Cycle: Molecular Biology Sub-Domain::MolecularBiomarkerGroup

: Public Class

Created:	3/3/2015 1:49:39 PM
Modified:	8/26/2017 2:24:25 AM

Project:
Author:	wverhoef
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{B89790DB-E2C4-4f03-B08D-3BF4F3D7EDA0}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View MB: Molecular Biology, SDTM 3.1.3 View

DEFINITION: A collection of molecular biomarkers that often associates observed molecular characteristics with medical conclusions or serves as an indicator of a particular biological condition or process. 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):

Attributes
Associations To
Associations From
Tagged Values

Attribute

Public ST
name

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:PGx v1.0=SB.SBMRKRID
Map:PGx v1.0=PB.PBMRKRID

Notes:

DEFINITION: A symbol that establishes identity of the molecular biomarker group. EXAMPLE(S): The identifier L10I+K20R+M36I+A71V+V82T is the concatenation of the names of individual biomarkers. [borrowed from CDISC's PGx IG] OTHER NAME(S): NOTE(S): At a minimum, this name should be unique within the submission, if not within the organization submitting it, but it is not necessarily intended to be globally unique.

Public ST
medicalStatement

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:PGx v1.0=PB.PBSTMT

Notes:

DEFINITION: A medical conclusion associated with a molecular biomarker group. EXAMPLE(S): Resistant, Poor Metabolizer, Susceptible, Good Metabolizer (when biomarker is related to a drug) Positive, Negative, Increased Risk, Decreased Risk, Medium Risk, High Risk (when biomarker is related to a diagnosis). OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
DefinedDiagnosis Class	Name: indicatingMolecularBiomarkerGroup	Name: indicatedDefinedDiagnosis
Details: DESCRIPTION:<br/>Each MolecularBiomarkerGroup might indicate risk or presence of one or more DefinedDiagnosis. Each DefinedDiagnosis might have risk or presence indicated by one or more MolecularBiomarkerGroup. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/>The MolecularBiomarkerGroup consisting of the individual biomarker "2073A#gt;T" indicates a decreased risk of "Diffusely Infiltrating Astrocytoma".<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Gene Class	Name: basingMolecularBiomarkerGroup	Name: basedGene
Details: DESCRIPTION:<br/>Each MolecularBiomarkerGroup might be based on one or more Gene. Each Gene might be the basis of one or more MolecularBiomarkerGroup.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Drug Class	Name: affectingMolecularBiomarkerGroup	Name: affectedDrug
Details: DESCRIPTION:<br/>Each MolecularBiomarkerGroup might impact the effectiveness of one or more Drug. Each Drug might have effectiveness impacted by one or more MolecularBiomarkerGroup. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/>Molecular Biomarker Group "L10I+K20R+M36I+A71V+V82T" links a set of mutations with the conclusion of drug resistance to the drug "lndinavir".<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Protein Class	Name: basingMolecularBiomarkerGroup	Name: basedProtein
Details: DESCRIPTION:<br/>Each MolecularBiomarkerGroup might be based on one or more Protein. Each Protein might be the basis of one or more MolecularBiomarkerGroup.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Element	Source Role	Target Role
PerformedGeneticInterpretation Class	Name: matchingPerformedGeneticInterpretation	Name: matchedMolecularBiomarkerGroup
Details: DESCRIPTION:<br/>Each PerformedGeneticInterpretation might match one MolecularBiomarkerGroup. Each MolecularBiomarkerGroup might be a match for one or more PerformedGeneticInterpretation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudiedMolecularBiomarkerGroup Class	Name: studyingStudiedMolecularBiomarkerGroup	Name: studiedMolecularBiomarkerGroup
Details: DESCRIPTION:<br/>Each StudiedMolecularBiomarkerGroup always is studying one MolecularBiomarkerGroup. Each MolecularBiomarkerGroup might be studied by one or more StudiedMolecularBiomarkerGroup.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
MolecularBiomarker Class	Name: groupedMolecularBiomarker	Name: groupingMolecularBiomarkerGroup
Details: DESCRIPTION:<br/>Each MolecularBiomarker might be grouped into one MolecularBiomarkerGroup. Each MolecularBiomarkerGroup always groups one or more MolecularBiomarker.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Tag	Value
Map:PGx v1.0	PB.STUDYID
Details: