| Dimensional Warehouse 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. |
Primary Key | |
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Dependencies | |
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Reverse Dependencies | |
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Attribute Details |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Classification of the adverse event. For example: Bleeding Hypoglycemia |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies whether the image is enhanced by the use of a contrast agent. |
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 |
Description | The textual representation for how an image is enhanced either physically or electronically. |
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 |
Description | The numeric value to indicate an increase in voxel signal over time for an MRI, expressed as signal intensity units per second. |
Data Type | Standards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies a subdivision within a larger category of an adverse event. For example: Neurologic |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | Identifies the appearance of a superficial lesion. For example: Flat Nodular |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
Description | The surrogate key of the load information entry describing the details regarding the loading of the row in the atomic data warehouse. |
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 |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
Description | Specifies the anatomic site (single) in contact with the lesion. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Set to 'Y' if this is the most recent row of a group having the same Surrogate Key. |
Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Classification of the adverse event. For example: Bleeding Hypoglycemia |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies whether the image is enhanced by the use of a contrast agent. |
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 |
Description | A 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 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 |
Description | The textual representation for how an image is enhanced either physically or electronically. |
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 |
Description | The numeric value to indicate an increase in voxel signal over time for an MRI, expressed as signal intensity units per second. |
Data Type | Standards - Data Domains.ddm/Data Domains/Rate [FLOAT(5)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Additional description of the observation result. |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies a subdivision within a larger category of an adverse event. For example: Neurologic |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | The coding system to use for recording results for the associated activity or evaluation. |
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 |
Description | Specifies 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 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 |
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. |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | The sequence or position of a component in a list of question or data items. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
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 |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies whether the specific eligibility criterion is not applicable to this participant. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
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 | true |
Description | Concatenated values of a set of business attributes that uniquely identify the row. |
Data Type | Standards - Data Domains.ddm/Data Domains/Business Key [VARCHAR(255)] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional 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 |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | Specifies a subdivision within a larger category of a protocol deviation. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
Description | Specifies whether this reply is necessary to include/exclude a potential subject on a 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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | The code that corresponds to the Source Code Sk. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | Specifies the phase in the lifecycle of the reported result. For example: Preliminary Final Corrected |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the dimensional model. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
Description | A numeric surrogate key used to uniquely identify entities in the atomic model. |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Surrogate Key [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
Description | Specifies the numeric grade for the toxicity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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/Tenant Common Code [VARCHAR(80)] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 | false |
Is Required | true |
Is Derived | false |
Is Surrogate Key | false |
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 |
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 |
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 |
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 |
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 |
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 |
Is Identifying Relationship | false |
Child Table | Observation Result Fact |
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 | Product Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Observation Result Fact |
Child Role Name | authorizing |
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 | Party Role Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Observation Result Fact |
Child Role Name | performing |
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 | Party Role Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Observation Result Fact |
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 | Document Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Observation Result Fact |
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 Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Is Identifying Relationship | false |
Child Table | Observation Result Fact |
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 Protocol Dimension |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | NONE |
Parent Referential Integrity: On Update | NONE |
Primary Key Details |
Key Attribute | Observation Fact Dk |
| Dimensional Warehouse Model Data Model |