As Collected IndBiomarker IndInfectious Agent TxtNormal Range ComparisonResult StatusTarget Biomarker Code
| Business Data Model Data Model |
| Description | A performed observation result that is from an examination, test or direct observation performed on the experimental unit. For example: The performed observation of "WBC count" would be associated to a clinical result called "WBC result" in which the results of the observation (7500 WBCs) would be stored. There is an association between the observation that has the original data (and the original units) and the observation in which the data elements have been converted into standardized units. |
| Attributes | |
| As Collected Ind |
|
| Biomarker Ind |
|
| Infectious Agent Txt |
|
| Normal Range Comparison |
|
| Result Status |
|
| Target Biomarker Code |
|
| Relationship | |
 convertedPerformedClinicalResult |
|
| Generalization | |
 R_1622 |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
As Collected Ind
| Description | An indicator that 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 want 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 |
Biomarker Ind
| Description | Specifies whether a result is considered a biomarker. This is based on a result as stated in the NCI Thesaurus for Biomarker: A variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. Biomarkers include but not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substances. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Infectious Agent Txt
| Description | The name of the specific microbe that the test is intended to identify. For example: Streptococcus pneumoniae Staphylococcus aureus |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Normal Range Comparison
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Result Status
| Description | Specifies the phase in the lifecycle of the reported result. For example: Preliminary Final Corrected |
| 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 Biomarker Code
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
convertedPerformedClinicalResult
| Is Identifying Relationship | false |
| Child Table | Performed Clinical Result |
| Child Role Name | originalPerformedClinicalResult |
| 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 Clinical Result |
| Parent Role Name | convertedPerformedClinicalResult |
| 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 |
| Generalization Details |
R_1622
| Supertype | Performed Observation Result |
| Subtype | Performed Clinical Result |
| Transform As | TABLE |
| Business Data Model Data Model |