Atomic Warehouse Model Data Model

Entity

Entity Performed Observation Result Detail

Description

A 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 Ind
Appearance Type Code Sk
As Collected Ind
Baseline Ind
Biomarker Ind
Body System Code Sk
Category Code Sk
Clinical Interpretation Severity Code Sk
Clinically Significant Ind
Comment Txt
Conclusion Txt
Confidentiality Code Sk
Contact Anatomic Site Code Sk
Defect Type Code Sk
Device Malfunction Code Sk
Differentiation Grade Code Sk
Dimension Product Qty
Disease Status Code Sk
Disease Status Missing Reason Code Sk
Effective From Dt
Effective To Dt
End Relative To Reference Code Sk
Evaluation Conclusion Code Sk
Expected Ind
Grade Code Sk
Highlighted Ind
Hospitalization Required Ind
Identification Num
Infectious Agent Txt
Involved Surgical Margin Ind
Lesion Qty
Load Info Sk
Location Descr
Measurable Ind
Medical Condition Clinically Significant Ind
Medical Condition End Relative To Reference Code Sk
Medical Condition Occurrence Date Range Qty
Medical Condition Occurrence Date Range Validation Code Sk
Medical Condition Severity Code Sk
Medical History Ind
Normal Range Comparison Code Sk
Occurrence From Ts
Occurrence Pattern Code Sk
Occurrence To Ts
Performed Observation Result Sk
Post Report Update Dt
Protocol Deviation Category Code Sk
Protocol Deviation Occurrence Date Range Qty
Protocol Deviation Severity Code Sk
Protocol Deviation Subcategory Code Sk
Recurrence Ind
Reported Dt
Result Classification Code Sk
Result Type Code Sk
Severity Code Sk
Source Code Sk
Status Code Sk
Subcategory Code Sk
Summary Txt
Target Anatomic Site Laterality Code Sk
Target Biomarker Code Sk
Tenant Sk
Toxicity Grade Code Sk
Toxicity Term Code Sk
Treatment Emergent Ind
Type Code Sk
Uncertainty Code Sk
Unexpected Reason Code Sk
Valid From Ts
Valid To Ts
Value
Value Code Modified Txt
Value Null Flavor Reason txt
xDimension Qty
yDimension Qty
zDimension Qty

Relationship
Performed Observation Result Detail_Performed Observation Result_FK

Primary Key
Performed Observation Result Detail PK

Dependencies

Reverse Dependencies

Attribute Details

Abnormal Ind

Description	Specifies whether an interpreted event is abnormal.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Appearance Type Code Sk

Description	Identifies the appearance of a superficial lesion. For example: Flat Nodular
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

As Collected Ind

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Baseline Ind

Description	Specifies whether the result is a starting point to which other results may be compared.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Biomarker Ind

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Body System Code Sk

Description	Specifies the anatomical structure that consists of organs and organ subclasses responsible for certain body functions. For example: Gastrointestinal system Urinary system Hematopoietic system
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Category Code Sk

Description	Classification of the adverse event. For example: Bleeding Hypoglycemia
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Clinical Interpretation Severity Code Sk

Description	Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Clinically Significant Ind

Description	Specifies whether a subject's clinical condition is important based on judgment.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Comment Txt

Description	Additional 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 Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Conclusion Txt

Description	A text or otherwise formatted description of the final results drawn from the investigation.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Confidentiality Code Sk

Description	The 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Contact Anatomic Site Code Sk

Description	Specifies the anatomic site (single) in contact with the lesion.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Defect Type Code Sk

Description	Specifies the kind of device-related events that characterize the reported event/problem. For example: malfunction
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Device Malfunction Code Sk

Description	A 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Differentiation Grade Code Sk

Description	Specifies the degree of cellular differentiation in a tissue sample. For example: A brain tumor could be grade 3
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Dimension Product Qty

Description	The result or product of multiplying dimensions (2 or 3) of a site or specimen.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Disease Status Code Sk

Description	Specifies the amount of disease present in a subject. For example: metastatic and disease-free (cancer-specific examples)
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Disease Status Missing Reason Code Sk

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Effective From Dt

Description	Establishes a period where a set of attributes are true according to the business.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Effective To Dt

Description	Ends a period of effectivity.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

End Relative To Reference Code Sk

Description	Specifies when this event ended with respect to the sponsor-defined reference period. For example: Before During During/after After
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Evaluation Conclusion Code Sk

Description	A 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Expected Ind

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Grade Code Sk

Description	A 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Highlighted Ind

Description	Specifies whether the adverse event or reaction term is a major concern or reason for reporting the adverse event.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Hospitalization Required Ind

Description	Specifies whether the subject or study subject requires hospitalization or prolongation of existing hospitalization as a result of the adverse event.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Identification Num

Description	The unique symbol that establishes identity of the observation result.
Data Type	Standards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Infectious Agent Txt

Description	The name of the specific microbe that the test is intended to identify. For example: Streptococcus pneumoniae Staphylococcus aureus
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Involved Surgical Margin Ind

Description	Specifies whether the margins of surgical resection are infiltrated by the abnormal tissue.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Lesion Qty

Description	The 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 Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Load Info Sk

Description	The surrogate key of the load information entry describing the details regarding the loading of the row.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Location Descr

Description	The textual representation of the physical location of the subject or study subject when the adverse event began.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Measurable Ind

Description	Specifies whether a lesion or site of disease is measurable.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Medical Condition Clinically Significant Ind

Description	Specifies whether a subject's clinical condition is important based on judgment.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Medical Condition End Relative To Reference Code Sk

Description	Specifies when this event ended with respect to the sponsor-defined reference period. For example: Before During During/after After
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Medical Condition Occurrence Date Range Qty

Description	The date and time span in which the medical condition began and ended.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Medical Condition Occurrence Date Range Validation Code Sk

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Medical Condition Severity Code Sk

Description	Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Medical History Ind

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Normal Range Comparison Code Sk

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Occurrence From Ts

Description	The date and time span in which the adverse event began.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Occurrence Pattern Code Sk

Description	Specifies the time recurrence by which an adverse event occurs. For example: Intermittent Continuous Single event
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Occurrence To Ts

Description	The date and time span in which the adverse event ended.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Performed Observation Result Sk

Description	Surrogate key for the anchor entity.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	true
Is Required	true
Is Derived	false
Is Surrogate Key	false

Post Report Update Dt

Description	The date (and time) on which the adverse event was updated after it had been submitted.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Protocol Deviation Category Code Sk

Description	Classification 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Protocol Deviation Occurrence Date Range Qty

Description	The date and time span specifying when the protocol deviation began and ended.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Protocol Deviation Severity Code Sk

Description	Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Protocol Deviation Subcategory Code Sk

Description	Specifies a subdivision within a larger category of a protocol deviation.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Recurrence Ind

Description	Specifies whether this is a reappearance of the existing disease.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Reported Dt

Description	The date and time the result for a performed observation in a clinical trial or study is noted.
Data Type	Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Result Classification Code Sk

Description	The 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Result Type Code Sk

Description	Code identifying the actual type of the entity as per the type hierarchy defined in the business data model. For example: Performed Product Problem Discovery Adverse Event Performed Protocol Deviation Performed Histopathology Performed Clinical Interpretation Performed Product Investigation Result Performed Lesion Description Performed Clinical Result Performed Diagnosis Performed Medical Condition Result
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Severity Code Sk

Description	Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Source Code Sk

Description	The 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Status Code Sk

Description	Specifies the phase in the lifecycle of the reported result. For example: Preliminary Final Corrected
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Subcategory Code Sk

Description	Specifies a subdivision within a larger category of an adverse event. For example: Neurologic
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Summary Txt

Description	A description of the adverse event and the treatment of the event.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Anatomic Site Laterality Code Sk

Description	Specifies the side of the body (or a paired organ) that is a target site for an observation. For example: Bilateral Left Right
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Biomarker Code Sk

Description	A 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Tenant Sk

Description	The surrogate key of the entry identifying the legal owner of the data.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Toxicity Grade Code Sk

Description	Specifies the numeric grade for the toxicity.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Toxicity Term Code Sk

Description	Specifies 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Treatment Emergent Ind

Description	Specifies whether the adverse event is something that first arose or become more severe during the studied treatment.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Type Code Sk

Description	Identifies the actual type of the entry based on the entity type hierarchy defined in the business data model.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Uncertainty Code Sk

Description	Describes 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 Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Unexpected Reason Code Sk

Description	Describes why an adverse event (experience or reaction) is considered unanticipated. For example: Severity Frequency Specificity from what has been previously documented
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Valid From Ts

Description	Establishes 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 Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	true
Is Required	true
Is Derived	false
Is Surrogate Key	false

Valid To Ts

Description	Ends a period of validity.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Value

Description	Data 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 Type	Standards - Data Domains.ddm/Data Domains/Text Very Large [VARCHAR(2048)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Value Code Modified Txt

Description	A 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 Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Value Null Flavor Reason txt

Description	The text and/or code that describes why no result was provided. For example: Subject refused to answer question.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

xDimension Qty

Description	The 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 Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

yDimension Qty

Description	The measurement of a lesion in the 'Y' (second or width) dimension.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

zDimension Qty

Description	The measurement of a lesion in the 'Z' (third) dimension.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Relationship Details

Performed Observation Result Detail_Performed Observation Result_FK

Is Identifying Relationship	true
Child Table	Performed Observation Result Detail
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	NONE
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	NONE
Parent Table	Performed Observation Result
Parent Multiplicity	ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	NONE
Parent Referential Integrity: On Update	NONE

Primary Key Details

Performed Observation Result Detail PK

Key Attribute	Performed Observation Result Sk
Key Attribute	Valid From Ts

Overview

Top

Package

Entity

Atomic Warehouse Model Data Model