Experimental Unit StatusExperimental Unit Status Date and TimeExperimental Unit SubgroupIdentification Num
| Business Data Model Data Model |
| Description | A physical entity that is the primary unit of interest in a specific research objective. For example: If all pigs in a pen receive the same intervention in their feed, and the primary observations and analyses of interest are associated with the entire pen (for example, total feed consumed, total weight of all pigs combined), then the pen of pigs rather than the individual animal is the experimental unit. [example from the CDISC/HL7 Study Participation message] A human may have 10 patches of skin each considered an experimental unit. A product may have 10 bearings in it, each considered an experimental unit. Alternatively, the whole human or product may be an experimental unit. Depending on the research objectives, a single study may have multiple levels of experimental units, such as whole people and patches of skin. In an interventional study, the experimental unit is assigned to an intervention. The experimental unit is also the unit of primary statistical analysis. Commonly the individual study subject (animal, person or product) is the experimental unit. Different experimental units must be capable of receiving different experimental interventions. |
| Attributes | |
| Experimental Unit Status |
|
| Experimental Unit Status Date and Time |
|
| Experimental Unit Subgroup |
|
| Identification Num |
|
| Relationship | |
 performedExperimentalUnit/1 |
|
| involvedExperimentalUnit |
|
| performedExperimentalUnit/2 |
|
| performedExperimentalUnit |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Experimental Unit Status
| Description | The phase in the lifecycle of the experimental unit. For example: Active Canceled Pending Suspended Terminated Nullified |
| 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 |
Experimental Unit Status Date and Time
| Description | The date and time the status for an experimental unit as part of a study or clinical trial is defined. |
| 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 |
Experimental Unit Subgroup
| Description | Specifies the identification of uniform groups of experimental units for separate analysis or treatment. For example: Clinical Data Update System (CDUS) Reporting (for the National Cancer Institute (NCI) |
| 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 | A unique symbol that establishes identity of the experimental unit. For example: Patient number 7 on a study |
| 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 |
| Relationship Details |
performedExperimentalUnit/1
| Description | |
| Is Identifying Relationship | false |
| Child Table | Experimental Unit |
| Child Role Name | performingBiologicEntityGroup |
| 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 | Biologic Entity Group |
| Parent Role Name | performedExperimentalUnit |
| 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 |
involvedExperimentalUnit
| Description | |
| Is Identifying Relationship | false |
| Child Table | Experimental Unit |
| Child Role Name | involvingActivity |
| 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 | Activity |
| Parent Role Name | involvedExperimentalUnit |
| 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 |
performedExperimentalUnit/2
| Description | |
| Is Identifying Relationship | false |
| Child Table | Experimental Unit |
| Child Role Name | performingBiologicEntityPart |
| 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 | Biologic Entity Part |
| Parent Role Name | performedExperimentalUnit |
| 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 |
performedExperimentalUnit
| Description | |
| Is Identifying Relationship | false |
| Child Table | Experimental Unit |
| Child Role Name | performingBiologicEntity |
| 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 | Biologic Entity |
| Parent Role Name | performedExperimentalUnit |
| 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 |
| Business Data Model Data Model |