Approach Anatomic SiteBody PositionFocal Date Range QtyFocal Duration QtyObservation MethodTarget Anatomic SiteTarget Anatomic Site Laterality
| Business Data Model Data Model |
| Description | An activity defined at a global library level whose intention is to obtain a result by observing, monitoring, measuring or otherwise qualitatively or quantitatively gathering data or information about one or more aspects of a subject's, study subject's or experimental unit's physiologic or psychologic state. For example: Blood chemistry panel Body mass index calculation Blood pressure measurement |
| Attributes | |
| Approach Anatomic Site |
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| Body Position |
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| Focal Date Range Qty |
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| Focal Duration Qty |
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| Observation Method |
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| Target Anatomic Site |
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| Target Anatomic Site Laterality |
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| Relationship | |
 Defined Observation_Focusing Defined Observation Result_FK |
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| Defined Observation_Produced Defined Observation Result_FK |
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| Generalization | |
 Generalization1 |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
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| Attribute Details |
Approach Anatomic Site
| Description | Identifies 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 Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Body Position
| Description | Specifies the 3-dimensional spatial orientation of a subject during a particular observation. For example: Supine Trendelenburg Standing |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Focal Date Range Qty
| Description | The 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 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 |
Focal Duration Qty
| Description | A 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 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 |
Observation Method
| Description | Specifies 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 Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Target Anatomic Site
| Description | Specifies 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 Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Target Anatomic Site Laterality
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
Defined Observation_Focusing Defined Observation Result_FK
| Is Identifying Relationship | false |
| Child Table | Defined Observation |
| 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 | Defined Observation Result |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Defined Observation_Produced Defined Observation Result_FK
| Is Identifying Relationship | false |
| Child Table | Defined Observation |
| 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 | Defined Observation Result |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Generalization Details |
Generalization1
| Supertype | Activity |
| Subtype | Defined Observation |
| Transform As | TABLE |
| Business Data Model Data Model |