ResultClassification

: Public Class

Created:	3/5/2015 3:01:31 PM
Modified:	3/17/2015 12:16:23 AM

Project:
Author:	wverhoef
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{F39E5CC4-973E-4c6e-BE49-9DBFF1B4DD53}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct

DEFINITION: A category describing the result as distinguished by anatomical or physiological system, etiology, or purpose. EXAMPLE(S): Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Infections and infestations Injury, poisoning and procedural complications Investigations Social circumstances Surgical and medical procedures OTHER NAME(S): System Organ Class Body System Low Level Term High Level Term High Level Group Term NOTE(S): Examples provided here are a sampling from the values for MedDRA System Organ Class.

Attributes
Associations To
Tagged Values

Attribute

Public DSET<CD>
code

Details:

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

Map:HCTv1.0=CDE 2686142:Involvement and Extent of Disease.For the psoriatic arthritis / psoriasis specify the other involvement:
Map:HCTv1.0=CDE 2749007:Involvement and Extent of Disease.For the systemic lupus erythematosus (SLE), what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2685212:Involvement and Extent of Disease.Specify the other involvement of the systemic sclerosis:
Map:HCTv1.0=CDE 2750646:Involvement and Extent of Disease.Specify the type of wegener granulomatosis involvement:
Map:HCTv1.0=CDE 2749969:Involvement and Extent of Disease.For the wegener granulomatosis, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2749929:Involvement and Extent of Disease.Specify the other type of antiphospholipid syndrome involvement:
Map:HCTv1.0=CDE 2749605:Involvement and Extent of Disease.For the sjogren syndrome, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2674903:Involvement and Extent of Disease.Specify the other involvement for sjogren syndrome:
Map:HCTv1.0=CDE 2797538:Involvement and Extent of Disease.Specify the type of organ impairment /disorder:
Map:HCTv1.0=CDE 2749891:Involvement and Extent of Disease.For the polymyositis-dermatomyositis, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2750141:Involvement and Extent of Disease.For the rheumatoid arthritis, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2750124:Involvement and Extent of Disease.Specify the type of polyarteritis nodosa, classical or microscopic, involvement:
Map:HCTv1.0=CDE 2750535:Involvement and Extent of Disease.For the psoriatic arthritis / psoriasis, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2750529:Involvement and Extent of Disease.Specify the type of rheumatoid arthritis involvement:
Map:HCTv1.0=CDE 2686158:Involvement and Extent of Disease.For the multiple sclerosis, specify the other involvement:
Map:HCTv1.0=CDE 3082350:Involvement and Extent of Disease.Specify the site of extranodal involvement:
Map:HCTv1.0=CDE 2749918:Involvement and Extent of Disease.For the antiphospholipid syndrome, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2749585:Involvement and Extent of Disease.Specify the type of systemic lupus erythematosus (SLE) involvement:
Map:HCTv1.0=CDE 2750113:Involvement and Extent of Disease.For the polyarteritis nodosa, classical or microscopic, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2749910:Involvement and Extent of Disease.For the multiple sclerosis, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2748902:Involvement and Extent of Disease.For the systemic sclerosis, what was the involved organ or clinical problem?
Map:HCTv1.0=CDE 2953469:Involvement and Extent of Disease.Specify the lymphoma organ involved:
Map:HCTv1.0=CDE 2797573:Involvement and Extent of Disease.Specify the other organ impairment / disorder:
Map:HCTv1.0=CDE 2749904:Involvement and Extent of Disease.Specify the type of polymyositis-dermatomyositis involvement:
Map:HCTv1.0=CDE 3129555:Involvement and Extent of Disease.Was there extramedullary and / or extranodal involvement?
Map:NCI CRF Standard=CDE 2943864v1.0: MedDRA System Organ Class (SOC)
Map:SDTM IGv3.1.1=MH.MHBODSYS
Map:SDTM IGv3.1.1=AE.AEBODSYS
Map:SDTM IGv3.1.2=CE.CEBODSYS
Map:SDTM IGv3.1.2=MH.MHBODSYS
Map:SDTM IGv3.1.2=AE.AEBODSYS

Notes:

DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the category of the result as distinguished by anatomical or physiological system, etiology, or purpose#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Blood and lymphatic system disorders; Cardiac disorders; Congenital, familial and genetic disorders; Ear and labyrinth disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders and administration site conditions; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Injury, poisoning and procedural complications; Investigations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified (incl cysts and polyps); Nervous system disorders; Pregnancy, puerperium and perinatal conditions; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Social circumstances; Surgical and medical procedures; Vascular disorders#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S): #lt;br /#gt;#lt;/p#gt;#lt;p#gt;Body System#lt;br /#gt;#lt;/p#gt;#lt;p#gt;System Organ Class#lt;br /#gt;#lt;/p#gt;#lt;p#gt;High Level Term#lt;br /#gt;#lt;/p#gt;#lt;p#gt;High Level Group Term#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Low Level Term#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Examples provided here are from the values for MedDRA System Organ Class.#lt;br /#gt;#lt;/p#gt;

Public CD
typeCode

Details:

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

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of classification.#lt;br /#gt;#lt;/p#gt;#lt;p#gt; #lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;body system#lt;br /#gt;#lt;/p#gt;#lt;p#gt;low level term#lt;br /#gt;#lt;/p#gt;#lt;p#gt;high level term#lt;br /#gt;#lt;/p#gt;#lt;p#gt;high level group term#lt;br /#gt;#lt;/p#gt;#lt;p#gt;sponsor's primary system organ class#lt;br /#gt;#lt;/p#gt;#lt;p#gt;sponsor's secondary system organ class#lt;br /#gt;#lt;/p#gt;#lt;p#gt; #lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt; #lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
«Comment_Requested» PerformedObservationResult Class	Name: classifyingResultClassification	Name: classifiedPerformedObservationResult
Details: DESCRIPTION:<br /></p><p>Each ResultClassification always classifies one PerformedObservationResult. Each PerformedObservationResult might be classified by one or more ResultClassification.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

Tag	Value
Map:SDTMIGv3.1.3	AE.AEBDSYCD
Details: