Entity Observation Result Fact

DescriptionA finding that is obtained by observing, monitoring, measuring or otherwise qualitatively or quantitatively recording one or more aspects of physiologic or psychologic processes.

Attributes
Abnormal IndAbnormal Ind
Actual Approach Anatomic Site CdActual Approach Anatomic Site Cd
Actual Approach Anatomic Site Code SkActual Approach Anatomic Site Code Sk
Actual Body Position CdActual Body Position Cd
Actual Body Position Code SkActual Body Position Code Sk
Actual Body System CdActual Body System Cd
Actual Body System Code SkActual Body System Code Sk
Actual Category CdActual Category Cd
Actual Category Code SkActual Category Code Sk
Actual Confidentiality CdActual Confidentiality Cd
Actual Confidentiality Code SkActual Confidentiality Code Sk
Actual Contrast Agent Enhancement IndActual Contrast Agent Enhancement Ind
Actual Enhancement DescrActual Enhancement Descr
Actual Enhancement RtActual Enhancement Rt
Actual Method CdActual Method Cd
Actual Method Code SkActual Method Code Sk
Actual Result Comment TxtActual Result Comment Txt
Actual Result Type CdActual Result Type Cd
Actual Result Type Code SkActual Result Type Code Sk
Actual Severity CdActual Severity Cd
Actual Severity Code SkActual Severity Code Sk
Actual Subcategory CdActual Subcategory Cd
Actual Subcategory Code SkActual Subcategory Code Sk
Actual Target Anatomic Site CdActual Target Anatomic Site Cd
Actual Target Anatomic Site Code SkActual Target Anatomic Site Code Sk
Actual Target Anatomic Site Laterality CdActual Target Anatomic Site Laterality Cd
Actual Target Anatomic Site Laterality Code SkActual Target Anatomic Site Laterality Code Sk
Actual Value QtyActual Value Qty
Appearance Type CdAppearance Type Cd
Appearance Type Code SkAppearance Type Code Sk
Approach Anatomic Site Laterality CdApproach Anatomic Site Laterality Cd
Approach Anatomic Site Laterality Code SkApproach Anatomic Site Laterality Code Sk
As Collected IndAs Collected Ind
Authorizing Party Role DkAuthorizing Party Role Dk
Authorizing Party Role SkAuthorizing Party Role Sk
AWM Load Info SkAWM Load Info Sk
Baseline IndBaseline Ind
Biomarker IndBiomarker Ind
Body System CdBody System Cd
Body System Code SkBody System Code Sk
Clinical Interpretation Severity CdClinical Interpretation Severity Cd
Clinical Interpretation Severity Code SkClinical Interpretation Severity Code Sk
Clinically Significant IndClinically Significant Ind
Conclusion TxtConclusion Txt
Contact Anatomic Site CdContact Anatomic Site Cd
Contact Anatomic Site Code SkContact Anatomic Site Code Sk
Current IndCurrent Ind
Defect Type CdDefect Type Cd
Defect Type Code SkDefect Type Code Sk
Defined Approach Anatomic Site CdDefined Approach Anatomic Site Cd
Defined Approach Anatomic Site Code SkDefined Approach Anatomic Site Code Sk
Defined Body Position CdDefined Body Position Cd
Defined Body Position Code SkDefined Body Position Code Sk
Defined Category CdDefined Category Cd
Defined Category Code SkDefined Category Code Sk
Defined Confidentiality CdDefined Confidentiality Cd
Defined Confidentiality Code SkDefined Confidentiality Code Sk
Defined Contrast Agent Enhancement IndDefined Contrast Agent Enhancement Ind
Defined Derivation Expression TxtDefined Derivation Expression Txt
Defined Enhancement DescrDefined Enhancement Descr
Defined Enhancement RtDefined Enhancement Rt
Defined Focal Date Range QtyDefined Focal Date Range Qty
Defined Focal Duration QtyDefined Focal Duration Qty
Defined Method CdDefined Method Cd
Defined Method Code SkDefined Method Code Sk
Defined Result Comment TxtDefined Result Comment Txt
Defined Result Type CdDefined Result Type Cd
Defined Result Type Code SkDefined Result Type Code Sk
Defined Severity CdDefined Severity Cd
Defined Severity Code SkDefined Severity Code Sk
Defined Subcategory CdDefined Subcategory Cd
Defined Subcategory Code SkDefined Subcategory Code Sk
Defined Target Anatomic Site CdDefined Target Anatomic Site Cd
Defined Target Anatomic Site Code SkDefined Target Anatomic Site Code Sk
Defined Target Anatomic Site Laterality CdDefined Target Anatomic Site Laterality Cd
Defined Target Anatomic Site Laterality Code SkDefined Target Anatomic Site Laterality Code Sk
Defined Target Coding SystemDefined Target Coding System
Defined Value Negation IndDefined Value Negation Ind
Defined Value QtyDefined Value Qty
Device Malfunction CdDevice Malfunction Cd
Device Malfunction Code SkDevice Malfunction Code Sk
Differentiation Grade CdDifferentiation Grade Cd
Differentiation Grade Code SkDifferentiation Grade Code Sk
Dimension Product QtyDimension Product Qty
Disease Status CdDisease Status Cd
Disease Status Code SkDisease Status Code Sk
Disease Status Missing Reason CdDisease Status Missing Reason Cd
Disease Status Missing Reason Code SkDisease Status Missing Reason Code Sk
Display OrderDisplay Order
Document DkDocument Dk
Document SkDocument Sk
DWM Load Info SkDWM Load Info Sk
Effective From DtEffective From Dt
Effective To DtEffective To Dt
End Relative To Reference CdEnd Relative To Reference Cd
End Relative To Reference Code SkEnd Relative To Reference Code Sk
Evaluation Conclusion CdEvaluation Conclusion Cd
Evaluation Conclusion Code SkEvaluation Conclusion Code Sk
Expected IndExpected Ind
Focal End DtFocal End Dt
Focal Start DtFocal Start Dt
Grade CdGrade Cd
Grade Code SkGrade Code Sk
Highlighted IndHighlighted Ind
Hospitalization Required IndHospitalization Required Ind
Identification NumIdentification Num
Infectious Agent TxtInfectious Agent Txt
Involved Surgical Margin IndInvolved Surgical Margin Ind
Lesion QtyLesion Qty
Location DescrLocation Descr
Measurable IndMeasurable Ind
Medical Condition Clinically Significant IndMedical Condition Clinically Significant Ind
Medical Condition End Relative To Reference CdMedical Condition End Relative To Reference Cd
Medical Condition End Relative To Reference Code SkMedical Condition End Relative To Reference Code Sk
Medical Condition Occurrence Date Range QtyMedical Condition Occurrence Date Range Qty
Medical Condition Occurrence Date Range Validation CdMedical Condition Occurrence Date Range Validation Cd
Medical Condition Occurrence Date Range Validation Code SkMedical Condition Occurrence Date Range Validation Code Sk
Medical Condition Severity CdMedical Condition Severity Cd
Medical Condition Severity Code SkMedical Condition Severity Code Sk
Medical History IndMedical History Ind
Name Code Modified TxtName Code Modified Txt
Non Reason CdNon Reason Cd
Non Reason Code SkNon Reason Code Sk
Normal Range Comparison CdNormal Range Comparison Cd
Normal Range Comparison Code SkNormal Range Comparison Code Sk
Not Applicable IndNot Applicable Ind
Observation Fact DkObservation Fact Dk
Observation Result Fact BkObservation Result Fact Bk
Observation Result Fact SkObservation Result Fact Sk
Occurrence From TsOccurrence From Ts
Occurrence Pattern CdOccurrence Pattern Cd
Occurrence Pattern Code SkOccurrence Pattern Code Sk
Occurrence To TsOccurrence To Ts
Performing Party Role DkPerforming Party Role Dk
Performing Party Role SkPerforming Party Role Sk
Post Report Update DtPost Report Update Dt
Product DkProduct Dk
Product SkProduct Sk
Protocol Deviation Category CdProtocol Deviation Category Cd
Protocol Deviation Category Code SkProtocol Deviation Category Code Sk
Protocol Deviation Occurrence Date Range QtyProtocol Deviation Occurrence Date Range Qty
Protocol Deviation Severity CdProtocol Deviation Severity Cd
Protocol Deviation Severity Code SkProtocol Deviation Severity Code Sk
Protocol Deviation Subcategory CdProtocol Deviation Subcategory Cd
Protocol Deviation Subcategory Code SkProtocol Deviation Subcategory Code Sk
Recurrence IndRecurrence Ind
Reported DtReported Dt
Required IndRequired Ind
Result Classification CdResult Classification Cd
Result Classification Code SkResult Classification Code Sk
Source CdSource Cd
Source Code SkSource Code Sk
Standard Time IndStandard Time Ind
Status CdStatus Cd
Status Code SkStatus Code Sk
Study DkStudy Dk
Study Protocol DkStudy Protocol Dk
Study Protocol SkStudy Protocol Sk
Study SkStudy Sk
Summary TxtSummary Txt
Target Anatomic Site Condition CdTarget Anatomic Site Condition Cd
Target Anatomic Site Condition Code SkTarget Anatomic Site Condition Code Sk
Target Biomarker CdTarget Biomarker Cd
Target Biomarker Code SkTarget Biomarker Code Sk
Tenant SkTenant Sk
Toxicity Grade CdToxicity Grade Cd
Toxicity Grade Code SkToxicity Grade Code Sk
Toxicity Term CdToxicity Term Cd
Toxicity Term Code SkToxicity Term Code Sk
Treatment Emergent IndTreatment Emergent Ind
Uncertainty CdUncertainty Cd
Uncertainty Code SkUncertainty Code Sk
Unexpected Reason CdUnexpected Reason Cd
Unexpected Reason Code SkUnexpected Reason Code Sk
Valid From TsValid From Ts
Valid To TsValid To Ts
Value Code Modified TxtValue Code Modified Txt
Value Null Flavor Reason txtValue Null Flavor Reason txt
xDimension QtyxDimension Qty
yDimension QtyyDimension Qty
zDimension QtyzDimension Qty

Relationship
Observation Result Fact_Product Dimension_FKObservation Result Fact_Product Dimension_FK
Observation Result Fact_Party Role Dimension_FKObservation Result Fact_Party Role Dimension_FK
Observation Result Fact_Party Role Dimension_FK1Observation Result Fact_Party Role Dimension_FK1
Observation Result Fact_Document Dimension_FKObservation Result Fact_Document Dimension_FK
Observation Result Fact_Study Dimension_FKObservation Result Fact_Study Dimension_FK
Observation Result Fact_Study Protocol Dimension_FKObservation Result Fact_Study Protocol Dimension_FK

Primary Key
Observation Result Fact PKObservation Result Fact PK

Dependencies
 
 
 
 
 
 
 
 

Reverse Dependencies
 

Attribute Details

 Abnormal Ind
DescriptionSpecifies whether an interpreted event is abnormal.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Approach Anatomic Site Cd
DescriptionIdentifies the anatomic location or access point for an observation or procedure.
Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the access point for the measurement or observation and the target site is what is ultimately being evaluated.

For example:
Anus for a colonoscopy observation
Arm for an injection
Trans-abdominal for a nephrectomy
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Approach Anatomic Site Code Sk
DescriptionIdentifies the anatomic location or access point for an observation or procedure.
Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the access point for the measurement or observation and the target site is what is ultimately being evaluated.

For example:
Anus for a colonoscopy observation
Arm for an injection
Trans-abdominal for a nephrectomy
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Body Position Cd
DescriptionSpecifies the 3-dimensional spatial orientation of a subject during a particular observation.

For example:
Supine
Trendelenburg
Standing
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Body Position Code Sk
DescriptionSpecifies the 3-dimensional spatial orientation of a subject during a particular observation.

For example:
Supine
Trendelenburg
Standing
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Body System Cd
DescriptionSpecifies the anatomical structure that consists of organs and organ subclasses responsible for certain body functions.

For example:
Gastrointestinal system
Urinary system
Hematopoietic system
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Body System Code Sk
DescriptionSpecifies the anatomical structure that consists of organs and organ subclasses responsible for certain body functions.

For example:
Gastrointestinal system
Urinary system
Hematopoietic system
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Category Cd
DescriptionClassification of the adverse event.

For example:
Bleeding
Hypoglycemia
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Category Code Sk
DescriptionClassification of the adverse event.

For example:
Bleeding
Hypoglycemia
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Confidentiality Cd
DescriptionThe level of security and/or privacy surrounding the order or observation result.

For example:
Highly confidential
Not confidential
Confidential
Restricted
Do not reveal to study sponsor.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Confidentiality Code Sk
DescriptionThe level of security and/or privacy surrounding the order or observation result.

For example:
Highly confidential
Not confidential
Confidential
Restricted
Do not reveal to study sponsor.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Contrast Agent Enhancement Ind
DescriptionSpecifies whether the image is enhanced by the use of a contrast agent.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Enhancement Descr
DescriptionThe textual representation for how an image is enhanced either physically or electronically.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Enhancement Rt
DescriptionThe numeric value to indicate an increase in voxel signal over time for an MRI, expressed as signal intensity units per second.
Data TypeStandards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Method Cd
DescriptionSpecifies the technique used to perform the observation.

For example:
Arterial puncture, sphygmomanometry (for blood pressure measurement)
Global introspection, algorithm, bayesian (for Adverse Event causality)
Estrogen Receptor Assay, Progesterone Receptor Assay, p53 Assay (for clinical result assay)
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Method Code Sk
DescriptionSpecifies the technique used to perform the observation.

For example:
Arterial puncture, sphygmomanometry (for blood pressure measurement)
Global introspection, algorithm, bayesian (for Adverse Event causality)
Estrogen Receptor Assay, Progesterone Receptor Assay, p53 Assay (for clinical result assay)
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Result Comment Txt
DescriptionAdditional description of the observation result.

For example:
Comments from the investigator regarding the condition of the specimen or any other observation.
Comments in addition to the specimen condition from the central or performing laboratory describing the specimen.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Result Type Cd
DescriptionSpecifies the kind of observation result.

For example:
For blood pressure, the results might be 120 for systolic and 80 for diastolic, where systolic and diastolic are the types distinguishing the two numbers.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Result Type Code Sk
DescriptionSpecifies the kind of observation result.

For example:
For blood pressure, the results might be 120 for systolic and 80 for diastolic, where systolic and diastolic are the types distinguishing the two numbers.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Severity Cd
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Severity Code Sk
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Subcategory Cd
DescriptionSpecifies a subdivision within a larger category of an adverse event.

For example:
Neurologic
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Subcategory Code Sk
DescriptionSpecifies a subdivision within a larger category of an adverse event.

For example:
Neurologic
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Target Anatomic Site Cd
DescriptionSpecifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced.

For example:
Lower intestine
Arm
Breast
Ovary
Kidney
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Target Anatomic Site Code Sk
DescriptionSpecifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced.

For example:
Lower intestine
Arm
Breast
Ovary
Kidney
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Target Anatomic Site Laterality Cd
DescriptionSpecifies the side of the body (or a paired organ) that is a target site for an observation.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Target Anatomic Site Laterality Code Sk
DescriptionSpecifies the side of the body (or a paired organ) that is a target site for an observation.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Actual Value Qty
DescriptionData or information that is determined by an act of observation.

For example:
The result of a lab test, physical finding, self-reported symptom.
The adverse event term code.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Very Large [VARCHAR(2048)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Appearance Type Cd
DescriptionIdentifies the appearance of a superficial lesion.

For example:
Flat
Nodular
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Appearance Type Code Sk
DescriptionIdentifies the appearance of a superficial lesion.

For example:
Flat
Nodular
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Approach Anatomic Site Laterality Cd
DescriptionSpecifies the side of the body (or a paired organ) that is an access point for an observation or procedure.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Approach Anatomic Site Laterality Code Sk
DescriptionSpecifies the side of the body (or a paired organ) that is an access point for an observation or procedure.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 As Collected Ind
DescriptionSpecifies whether the observation is represented in the units or values as originally collected.

For example:
A performing lab may have completed the observation or lab test using conventional units, but the sponsor may wish to have the test reported in SI units. This flag will be set to "true" on the lab test that has the original units, and "false" on the lab test in which the units that are different than the lab test's original units.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Authorizing Party Role Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Authorizing Party Role Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 AWM Load Info Sk
DescriptionThe surrogate key of the load information entry describing the details regarding the loading of the row in the atomic data warehouse.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Baseline Ind
DescriptionSpecifies whether the result is a starting point to which other results may be compared.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Biomarker Ind
DescriptionSpecifies whether a result is considered a biomarker.
This is based on a result as stated in the NCI Thesaurus for Biomarker: A variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. Biomarkers include but not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substances.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Body System Cd
DescriptionSpecifies the anatomical structure that consists of organs and organ subclasses responsible for certain body functions.

For example:
Gastrointestinal system
Urinary system
Hematopoietic system
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Body System Code Sk
DescriptionSpecifies the anatomical structure that consists of organs and organ subclasses responsible for certain body functions.

For example:
Gastrointestinal system
Urinary system
Hematopoietic system
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Clinical Interpretation Severity Cd
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Clinical Interpretation Severity Code Sk
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Clinically Significant Ind
DescriptionSpecifies whether a subject's clinical condition is important based on judgment.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Conclusion Txt
DescriptionA text or otherwise formatted description of the final results drawn from the investigation.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Contact Anatomic Site Cd
DescriptionSpecifies the anatomic site (single) in contact with the lesion.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Contact Anatomic Site Code Sk
DescriptionSpecifies the anatomic site (single) in contact with the lesion.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Current Ind
DescriptionSet to 'Y' if this is the most recent row of a group having the same Surrogate Key.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Defect Type Cd
DescriptionSpecifies the kind of device-related events that characterize the reported event/problem.

For example:
malfunction
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defect Type Code Sk
DescriptionSpecifies the kind of device-related events that characterize the reported event/problem.

For example:
malfunction
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Approach Anatomic Site Cd
DescriptionIdentifies the anatomic location or access point for an observation or procedure.
Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the access point for the measurement or observation and the target site is what is ultimately being evaluated.

For example:
Anus for a colonoscopy observation
Arm for an injection
Trans-abdominal for a nephrectomy
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Approach Anatomic Site Code Sk
DescriptionIdentifies the anatomic location or access point for an observation or procedure.
Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the access point for the measurement or observation and the target site is what is ultimately being evaluated.

For example:
Anus for a colonoscopy observation
Arm for an injection
Trans-abdominal for a nephrectomy
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Body Position Cd
DescriptionSpecifies the 3-dimensional spatial orientation of a subject during a particular observation.

For example:
Supine
Trendelenburg
Standing
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Body Position Code Sk
DescriptionSpecifies the 3-dimensional spatial orientation of a subject during a particular observation.

For example:
Supine
Trendelenburg
Standing
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Category Cd
DescriptionClassification of the adverse event.

For example:
Bleeding
Hypoglycemia
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Category Code Sk
DescriptionClassification of the adverse event.

For example:
Bleeding
Hypoglycemia
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Confidentiality Cd
DescriptionThe level of security and/or privacy surrounding the order or observation result.

For example:
Highly confidential
Not confidential
Confidential
Restricted
Do not reveal to study sponsor.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Confidentiality Code Sk
DescriptionThe level of security and/or privacy surrounding the order or observation result.

For example:
Highly confidential
Not confidential
Confidential
Restricted
Do not reveal to study sponsor.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Contrast Agent Enhancement Ind
DescriptionSpecifies whether the image is enhanced by the use of a contrast agent.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Derivation Expression Txt
DescriptionA character string containing a formal language expression that specifies how the observation result's attributes are, should be, or have been derived from input parameters associated with activity.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Enhancement Descr
DescriptionThe textual representation for how an image is enhanced either physically or electronically.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Enhancement Rt
DescriptionThe numeric value to indicate an increase in voxel signal over time for an MRI, expressed as signal intensity units per second.
Data TypeStandards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Focal Date Range Qty
DescriptionThe time period in which the observation result is held to be true, expressed either as a simple date range or as an evaluable expression that references a study-defined date or milestone.

For example:
For a survey question, "Have you traveled to Europe between 1990 and 1999?", the focal date range would be "January 1, 1990 to December 31, 1999".
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Focal Duration Qty
DescriptionA quantity of time in which the observation result is held to be true.

For example:
2 months is the focal duration for the question, "Have you smoked in the last 2 months?"
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Method Cd
DescriptionSpecifies the technique used to perform the observation.

For example:
Arterial puncture, sphygmomanometry (for blood pressure measurement)
Global introspection, algorithm, bayesian (for Adverse Event causality)
Estrogen Receptor Assay, Progesterone Receptor Assay, p53 Assay (for clinical result assay)
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Method Code Sk
DescriptionSpecifies the technique used to perform the observation.

For example:
Arterial puncture, sphygmomanometry (for blood pressure measurement)
Global introspection, algorithm, bayesian (for Adverse Event causality)
Estrogen Receptor Assay, Progesterone Receptor Assay, p53 Assay (for clinical result assay)
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Result Comment Txt
DescriptionAdditional description of the observation result.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Result Type Cd
DescriptionSpecifies the kind of observation result.

For example:
For blood pressure, the results might be 120 for systolic and 80 for diastolic, where systolic and diastolic are the types distinguishing the two numbers.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Result Type Code Sk
DescriptionSpecifies the kind of observation result.

For example:
For blood pressure, the results might be 120 for systolic and 80 for diastolic, where systolic and diastolic are the types distinguishing the two numbers.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Severity Cd
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Severity Code Sk
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Subcategory Cd
DescriptionSpecifies a subdivision within a larger category of an adverse event.

For example:
Neurologic
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Subcategory Code Sk
DescriptionSpecifies a subdivision within a larger category of an adverse event.

For example:
Neurologic
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Target Anatomic Site Cd
DescriptionSpecifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced.

For example:
Lower intestine
Arm
Breast
Ovary
Kidney
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Target Anatomic Site Code Sk
DescriptionSpecifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced.

For example:
Lower intestine
Arm
Breast
Ovary
Kidney
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Target Anatomic Site Laterality Cd
DescriptionSpecifies the side of the body (or a paired organ) that is a target site for an observation.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Target Anatomic Site Laterality Code Sk
DescriptionSpecifies the side of the body (or a paired organ) that is a target site for an observation.

For example:
Bilateral
Left
Right
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Target Coding System
DescriptionThe coding system to use for recording results for the associated activity or evaluation.
Data TypeStandards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Value Negation Ind
DescriptionSpecifies whether, when the observation event occurred, the finding communicated by the value attribute was NOT found.
This should only be used when the terminology used for Defined Observation Result is not itself capable of expressing negated findings (for example, ICD9).
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Defined Value Qty
DescriptionData or information that is determined by an act of observation.

For example:
The result of a lab test, physical finding, self-reported symptom.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Very Large [VARCHAR(2048)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Device Malfunction Cd
DescriptionA coded value specifying the defect or malfunction that occurred during use of the suspect device whether or not the problem is associated with an adverse event. Codes are FDA CDRH device codes.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Device Malfunction Code Sk
DescriptionA coded value specifying the defect or malfunction that occurred during use of the suspect device whether or not the problem is associated with an adverse event. Codes are FDA CDRH device codes.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Differentiation Grade Cd
DescriptionSpecifies the degree of cellular differentiation in a tissue sample.

For example:
A brain tumor could be grade 3
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Differentiation Grade Code Sk
DescriptionSpecifies the degree of cellular differentiation in a tissue sample.

For example:
A brain tumor could be grade 3
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Dimension Product Qty
DescriptionThe result or product of multiplying dimensions (2 or 3) of a site or specimen.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Disease Status Cd
DescriptionSpecifies the amount of disease present in a subject.

For example:
metastatic and disease-free (cancer-specific examples)
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Disease Status Code Sk
DescriptionSpecifies the amount of disease present in a subject.

For example:
metastatic and disease-free (cancer-specific examples)
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Disease Status Missing Reason Cd
DescriptionSpecifies why a disease status is missing. The distinctions between unevaluable, missing reason and not assessed, will be made in the hierarchy of the reason codes and need not be made as distinct attributes, since they are mutually exclusive.

For example:
"the sample was damaged" is a reason code within the "unevaluable" classification.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Disease Status Missing Reason Code Sk
DescriptionSpecifies why a disease status is missing. The distinctions between unevaluable, missing reason and not assessed, will be made in the hierarchy of the reason codes and need not be made as distinct attributes, since they are mutually exclusive.

For example:
"the sample was damaged" is a reason code within the "unevaluable" classification.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Display Order
DescriptionThe sequence or position of a component in a list of question or data items.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Document Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Document Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 DWM Load Info Sk
DescriptionThe surrogate key of the load information entry describing the details regarding the loading of the row.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Effective From Dt
DescriptionEstablishes a period where a set of attributes are true according to the business.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Effective To Dt
DescriptionEnds a period of effectivity.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 End Relative To Reference Cd
DescriptionSpecifies when this event ended with respect to the sponsor-defined reference period.
For example:
Before
During
During/after
After
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 End Relative To Reference Code Sk
DescriptionSpecifies when this event ended with respect to the sponsor-defined reference period.
For example:
Before
During
During/after
After
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Evaluation Conclusion Cd
DescriptionA coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. Based on FDA CDRH Conclusion Codes.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Evaluation Conclusion Code Sk
DescriptionA coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. Based on FDA CDRH Conclusion Codes.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Expected Ind
DescriptionSpecifies whether the specificity (nature), frequency, or severity of an adverse event is consistent with the applicable study documentation (for example, investigator's brochure, protocol document, or consent document) or product labeling (package insert).
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Focal End Dt
DescriptionThe quantity of time in which the observation result is held to be true.

For example:
2 months is the focal duration for a question such as "Have you smoked in the last 2 months?".
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Focal Start Dt
DescriptionThe time period in which the observation result is held to be true.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Grade Cd
DescriptionA coded value specifying the level of injury suffered by the subject or study subject for whom the event is reported.

For example:
The grade code could be 3 if the CTCAE coding system is being used.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Grade Code Sk
DescriptionA coded value specifying the level of injury suffered by the subject or study subject for whom the event is reported.

For example:
The grade code could be 3 if the CTCAE coding system is being used.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Highlighted Ind
DescriptionSpecifies whether the adverse event or reaction term is a major concern or reason for reporting the adverse event.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Hospitalization Required Ind
DescriptionSpecifies whether the subject or study subject requires hospitalization or prolongation of existing hospitalization as a result of the adverse event.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Identification Num
DescriptionThe unique symbol that establishes identity of the observation result.
Data TypeStandards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Infectious Agent Txt
DescriptionThe name of the specific microbe that the test is intended to identify.

For example:
Streptococcus pneumoniae
Staphylococcus aureus
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Involved Surgical Margin Ind
DescriptionSpecifies whether the margins of surgical resection are infiltrated by the abnormal tissue.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Lesion Qty
DescriptionThe integer assigned to a lesion for a subject. Once a lesion number is designated for a specific lesion that number may not change or re-used to denote a different lesion.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Location Descr
DescriptionThe textual representation of the physical location of the subject or study subject when the adverse event began.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Measurable Ind
DescriptionSpecifies whether a lesion or site of disease is measurable.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition Clinically Significant Ind
DescriptionSpecifies whether a subject's clinical condition is important based on judgment.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition End Relative To Reference Cd
DescriptionSpecifies when this event ended with respect to the sponsor-defined reference period.

For example:
Before
During
During/after
After
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition End Relative To Reference Code Sk
DescriptionSpecifies when this event ended with respect to the sponsor-defined reference period.

For example:
Before
During
During/after
After
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition Occurrence Date Range Qty
DescriptionThe date and time span in which the medical condition began and ended.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition Occurrence Date Range Validation Cd
DescriptionSpecifies the degree of authoritativeness or certitude of the occurrence date.

For example:
Date estimated
Date > 100 days, date is correct
Date < 100 days, date is correct
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition Occurrence Date Range Validation Code Sk
DescriptionSpecifies the degree of authoritativeness or certitude of the occurrence date.

For example:
Date estimated
Date > 100 days, date is correct
Date < 100 days, date is correct
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition Severity Cd
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical Condition Severity Code Sk
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Medical History Ind
DescriptionSpecifies whether the condition is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Name Code Modified Txt
DescriptionA character string that is a revision of the original text of the procedure to enable the coding of the text.

For example:
If the original text is "message", the Name Code Modified Text could be set to "massage", so that the text can be successfully coded.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Non Reason Cd
DescriptionA coded value specifying the motivation, cause or rationale that is explicitly NOT why an activity occurred.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Non Reason Code Sk
DescriptionA coded value specifying the motivation, cause or rationale that is explicitly NOT why an activity occurred.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Normal Range Comparison Cd
DescriptionSpecifies the relationship of a value to a normal range or reference range of values.

For example:
High
Low
Within normal range
Outside normal range
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Normal Range Comparison Code Sk
DescriptionSpecifies the relationship of a value to a normal range or reference range of values.

For example:
High
Low
Within normal range
Outside normal range
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Not Applicable Ind
DescriptionSpecifies whether the specific eligibility criterion is not applicable to this participant.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Observation Fact Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeytrue
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keytrue



 Observation Result Fact Bk
DescriptionConcatenated values of a set of business attributes that uniquely identify the row.
Data TypeStandards - Data Domains.ddm/Data Domains/Business Key [VARCHAR(255)]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Observation Result Fact Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Occurrence From Ts
DescriptionThe date and time span in which the adverse event began.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Occurrence Pattern Cd
DescriptionSpecifies the time recurrence by which an adverse event occurs.

For example:
Intermittent
Continuous
Single event
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Occurrence Pattern Code Sk
DescriptionSpecifies the time recurrence by which an adverse event occurs.

For example:
Intermittent
Continuous
Single event
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Occurrence To Ts
DescriptionThe date and time span in which the adverse event ended.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Performing Party Role Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Performing Party Role Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Post Report Update Dt
DescriptionThe date (and time) on which the adverse event was updated after it had been submitted.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Product Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Product Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Category Cd
DescriptionClassification of protocol deviation.

For example:
Concomitant Medications
Data Integrity Compromised
Eligibility not checked
Eligibility waiver
Informed Consent
Other specify
Study Procedures
Treatment [NCI CRF Standard examples]
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Category Code Sk
DescriptionClassification of protocol deviation.

For example:
Concomitant Medications
Data Integrity Compromised
Eligibility not checked
Eligibility waiver
Informed Consent
Other specify
Study Procedures
Treatment [NCI CRF Standard examples]
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Occurrence Date Range Qty
DescriptionThe date and time span specifying when the protocol deviation began and ended.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Severity Cd
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Severity Code Sk
DescriptionSpecifies the intensity of an activity, event or condition.

For example:
Major
Moderate
Minor
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Subcategory Cd
DescriptionSpecifies a subdivision within a larger category of a protocol deviation.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Protocol Deviation Subcategory Code Sk
DescriptionSpecifies a subdivision within a larger category of a protocol deviation.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Recurrence Ind
DescriptionSpecifies whether this is a reappearance of the existing disease.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Reported Dt
DescriptionThe date and time the result for a performed observation in a clinical trial or study is noted.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Required Ind
DescriptionSpecifies whether this reply is necessary to include/exclude a potential subject on a study.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Result Classification Cd
DescriptionThe highest level of the terminology describing the result distinguished by anatomical or physiological system, etiology, or purpose.

For example:
Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Result Classification Code Sk
DescriptionThe highest level of the terminology describing the result distinguished by anatomical or physiological system, etiology, or purpose.

For example:
Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Source Cd
DescriptionThe code that corresponds to the Source Code Sk.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Source Code Sk
DescriptionThe origin of the data identifying the actual load source, vendor, manual key entry, or context of the data in a specific row in the database.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Standard Time Ind
DescriptionSpecifies whether the time of the process step is specified using standard (as opposed to daylight savings) time.
If the location and date are known, this data is derivable.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Cd
DescriptionSpecifies the phase in the lifecycle of the reported result.

For example:
Preliminary
Final
Corrected
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Status Code Sk
DescriptionSpecifies the phase in the lifecycle of the reported result.

For example:
Preliminary
Final
Corrected
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Protocol Dk
DescriptionA numeric surrogate key used to uniquely identify entities in the dimensional model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Protocol Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Study Sk
DescriptionA numeric surrogate key used to uniquely identify entities in the atomic model.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Summary Txt
DescriptionA description of the adverse event and the treatment of the event.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Anatomic Site Condition Cd
DescriptionSpecifies the state of the target anatomic site.

For example:
The subject's left arm was bruised where the IV was inserted.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Anatomic Site Condition Code Sk
DescriptionSpecifies the state of the target anatomic site.

For example:
The subject's left arm was bruised where the IV was inserted.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Biomarker Cd
DescriptionA coded value specifying a variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. This is the focus of an observation.

For example:
Biomarkers include but are not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substance.

For an observation with a Name Code of "Determine the Allele for the HLA-A Locus on Chromosome 6", the observation result might have a Target Biomarker Code of "HLA-A" and a value of "HLA-A*01:01:01" (the specific allele)
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Target Biomarker Code Sk
DescriptionA coded value specifying a variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. This is the focus of an observation.

For example:
Biomarkers include but are not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substance.

For an observation with a Name Code of "Determine the Allele for the HLA-A Locus on Chromosome 6", the observation result might have a Target Biomarker Code of "HLA-A" and a value of "HLA-A*01:01:01" (the specific allele)
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Tenant Sk
DescriptionThe surrogate key of the entry identifying the legal owner of the data.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Toxicity Grade Cd
DescriptionSpecifies the numeric grade for the toxicity.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Toxicity Grade Code Sk
DescriptionSpecifies the numeric grade for the toxicity.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Toxicity Term Cd
DescriptionSpecifies the degree to which a substance is able to damage an exposed organism. Similar to CTC Term (short name), for example, the National Cancer Institute's Common Toxicity Criteria terminology.

For example:
Hypocalcaemia
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Toxicity Term Code Sk
DescriptionSpecifies the degree to which a substance is able to damage an exposed organism. Similar to CTC Term (short name), for example, the National Cancer Institute's Common Toxicity Criteria terminology.

For example:
Hypocalcaemia
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Treatment Emergent Ind
DescriptionSpecifies whether the adverse event is something that first arose or become more severe during the studied treatment.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Uncertainty Cd
DescriptionDescribes whether and to what degree this evaluation or observation has been asserted to be in doubt in any way.

For example:
A patient might have had a cholecystectomy procedure in the past, but isn't sure what the outcome was.
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Uncertainty Code Sk
DescriptionDescribes whether and to what degree this evaluation or observation has been asserted to be in doubt in any way.

For example:
A patient might have had a cholecystectomy procedure in the past, but isn't sure what the outcome was.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Unexpected Reason Cd
DescriptionDescribes why an adverse event (experience or reaction) is considered unanticipated.

For example:
Severity
Frequency
Specificity from what has been previously documented
Data TypeStandards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Unexpected Reason Code Sk
DescriptionDescribes why an adverse event (experience or reaction) is considered unanticipated.

For example:
Severity
Frequency
Specificity from what has been previously documented
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Valid From Ts
DescriptionEstablishes a period where a set of attributes are true in the source system. This would be populated with the transaction timestamp and would be used for the snapshot date.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Valid To Ts
DescriptionEnds a period of validity.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Value Code Modified Txt
DescriptionA character string that is a revision of the original text observation result to enable the coding of the text.

For example:
If the Original Text is "hedache", the Value Code Modified Text could be changed to "headache", so that the text can be successfully coded.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Value Null Flavor Reason txt
DescriptionThe text and/or code that describes why no result was provided.

For example:
Subject refused to answer question.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 xDimension Qty
DescriptionThe measurement of a lesion or location in the 'X' (first or length) dimension. This is the longest measurement or largest value if only one measurement is captured.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 yDimension Qty
DescriptionThe measurement of a lesion in the 'Y' (second or width) dimension.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 zDimension Qty
DescriptionThe measurement of a lesion in the 'Z' (third) dimension.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse

Relationship Details

 Observation Result Fact_Product Dimension_FK
Is Identifying Relationshipfalse
Child TableObservation Result Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableProduct Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Observation Result Fact_Party Role Dimension_FK
Is Identifying Relationshipfalse
Child TableObservation Result Fact
Child Role Nameauthorizing
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableParty Role Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Observation Result Fact_Party Role Dimension_FK1
Is Identifying Relationshipfalse
Child TableObservation Result Fact
Child Role Nameperforming
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableParty Role Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Observation Result Fact_Document Dimension_FK
Is Identifying Relationshipfalse
Child TableObservation Result Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableDocument Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Observation Result Fact_Study Dimension_FK
Is Identifying Relationshipfalse
Child TableObservation Result Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE



 Observation Result Fact_Study Protocol Dimension_FK
Is Identifying Relationshipfalse
Child TableObservation Result Fact
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Protocol Dimension
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

 Observation Result Fact PK
Key AttributeObservation Fact Dk