| Business Data Model Data Model |
| Description | An outcome, measurement, result or other comment that is recorded as part of a study on a particular study subject. |
| Attributes | |
Descr |
|
Observation Method |
|
Observed Qty |
|
Observed Unit Of Measure |
|
Recorded Date |
|
| Relationship | |
Study Observation_Study_FK |
|
Study Observation_Study Subject_FK |
|
| Dependencies | |
NONE |
|
| Reverse Dependencies | |
|
|
| Attribute Details |
Descr
| Description | A qualitative textual description of the study observation. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Observation Method
| Description | Indicates 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 |
Observed Qty
| Description | The measured value associated with the study observation. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Float [FLOAT(15)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Observed Unit Of Measure
| Description | The unit of measure in which the measured value associated with the study observation is expressed. |
| 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 |
Recorded Date
| Description | The date upon which an observation in relation to a study was noted. |
| 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 |
| Relationship Details |
Study Observation_Study_FK
| Is Identifying Relationship | false |
| Child Table | Study 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 |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Study Observation_Study Subject_FK
| Is Identifying Relationship | false |
| Child Table | Study 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 Subject |
| 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 |