Group DescrGroup Num
| Business Data Model Data Model |
| Description | A designation that segregates study subjects into collections in order to balance the study for analysis. The stratum group is made up of a combination of stratification criterion answers, which ultimately is used to assign study subjects or experimental units to arms on a study. For example: A given study may want to require even distribution of gender and age so stratum groups may be defined as: males under 18, males 18 and over, females under 18, and females 18 and over. |
| Attributes | |
| Group Descr |
|
| Group Num |
|
| Relationship | |
 characterizedStratumGroup |
|
| randomizedStratumGroup |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Group Descr
| Description | The textual representation of the stratum group. For example: Primary malignancy Weight loss severity Concurrent therapy Patient age (years) Gleason score Baseline PSA |
| 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 |
Group Num
| Description | An integer that identifies the stratum group to study personnel, such as the statistician and registrars. For example: Patient age (years) Stratum A Gender |
| 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 |
characterizedStratumGroup
| Is Identifying Relationship | false |
| Child Table | Stratum Group |
| Child Role Name | characterizingDefinedStratificationCriterionPermissibleResult |
| 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 | Defined Criterion Permissible Result |
| Parent Role Name | characterizedStratumGroup |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
randomizedStratumGroup
| Description | |
| Is Identifying Relationship | false |
| Child Table | Stratum Group |
| Child Role Name | randomizingRandomizationBookEntry |
| 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 | Randomization Book Entry |
| Parent Role Name | randomizedStratumGroup |
| 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 |