Baseline IndComment TxtConfidentiality LevelIdentification NumObservation Report Date and TimeObservation Result TypeResult ClassificationTarget Anatomic Site LateralityUncertaintyValueValue Code Modified TxtValue Null Flavor Reason txt
| Business Data Model Data Model |
| 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. |
| Dependencies | |
 NONE |
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| Reverse Dependencies | |
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| Attribute Details |
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 |
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 |
Confidentiality Level
| Description | The level of security, privacy, or both, 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/Enumeration [VARCHAR(20)] |
| 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 |
Observation Report Date and Time
| 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 |
Observation Result Type
| Description | Specifies 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 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 |
Result Classification
| 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/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 |
Uncertainty
| 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/Enumeration [VARCHAR(20)] |
| 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, code, or both, that describe 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 |
| Relationship Details |
assessedPerformedObservationResult
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Observation Result |
| Child Role Name | assessingAssessedResultRelationship |
| 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 | assessedPerformedObservationResult |
| 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 |
evaluatedPerformedObservationResult
| Is Identifying Relationship | false |
| Child Table | Performed Observation Result |
| Child Role Name | evaluatingEvaluatedResultRelationship |
| 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 | Evaluated Result |
| Parent Role Name | evaluatedPerformedObservationResult |
| 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 |
resultedPerformedObservationResult
| Description | |
| Is Identifying Relationship | false |
| Child Table | Performed Observation Result |
| Child Role Name | producingPerformedObservation |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | RESTRICT |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | RESTRICT |
| Parent Table | Activity Observation |
| Parent Role Name | resultedPerformedObservationResult |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | RESTRICT |
| Parent Referential Integrity: On Update | RESTRICT |
triggeringPerformedObservationResult
| Is Identifying Relationship | false |
| Child Table | Performed Observation Result |
| Child Role Name | triggeredObservationResultActionTakenRelationship |
| 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 | Observation Result Action Taken |
| Parent Role Name | triggeringPerformedObservationResult |
| 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 |
infersPerformedObservationResult
| Is Identifying Relationship | false |
| Child Table | Performed Observation Result |
| Child Role Name | inferredPerformedObservationResult |
| 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 | Performed Observation Result |
| Parent Role Name | infersPerformedObservationResult |
| 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 |
Performed Observation Result_Clinical Finding_FK
| Is Identifying Relationship | false |
| Child Table | Performed Observation Result |
| 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 | Clinical Finding |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Business Data Model Data Model |