| Business Data Model Data Model |
| Description | A completed action of observing, monitoring, measuring or otherwise qualitatively or quantitatively gathering data or information about one or more aspects of a subject, study subject, or experimental unit. For example: Lab test Taking vital signs Physical exam |
| 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 |
Approach Anatomic Site Laterality
| Description | Specifies 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 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 |
Body System
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Focal End Date
| Description | The 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 Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Focal Start Date
| Description | The time period in which the observation result is held to be true. |
| 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 |
Name Code Modified Txt
| Description | A 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 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 |
Non Reason Code
| Description | A coded value specifying the motivation, cause or rationale that is explicitly NOT why an activity occurred. |
| 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 |
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 |
Standard Time Ind
| Description | Specifies 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 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 |
Target Anatomic Site
| Description | The anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result can be different to the target site of the observation that generated it. For example; The target site of the observation can be broad, such as "skin", while the target site of the observation result is specific, such as "skin on chest". Multiple contiguous sites within the same organ system can 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 Condition
| Description | Specifies the state of the target anatomic site. For example: The subject's left arm was bruised where the IV was inserted. |
| 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 |
commentingPerformedObservation
| Description | |
| Is Identifying Relationship | false |
| Child Table | Activity Observation |
| Child Role Name | commentedSafetyReportVersion |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Safety Report |
| Parent Role Name | commentingPerformedObservation |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
assessingPerformedObservation
| Is Identifying Relationship | false |
| Child Table | Activity Observation |
| Child Role Name | assessedAssessedActivityRelationship |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Assessed Activity |
| Parent Role Name | assessingPerformedObservation |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
assessingPerformedObservation/1
| Is Identifying Relationship | false |
| Child Table | Activity Observation |
| Child Role Name | assessedAssessedResultRelationship |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Assessed Result |
| Parent Role Name | assessingPerformedObservation |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
Activity Observation_Activity_FK
| Is Identifying Relationship | true |
| Child Table | Activity 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 | Activity |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Activity Observation_Material_FK
| Is Identifying Relationship | false |
| Child Table | Activity 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 | Material |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Activity Observation_Study / Personnel_FK
| Is Identifying Relationship | false |
| Child Table | Activity 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 | Study / Personnel |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Business Data Model Data Model |