Anticipated IndStatus Comment TxtStudy Overall Status Date and TimeStudy StatusStudy Stopped Reason
| Business Data Model Data Model |
| Description | Describes the comprehensive state of the study. The actual overall status of a study may be derived if it is possible to roll-up the site-specific status. |
| Attributes | |
| Anticipated Ind |
|
| Status Comment Txt |
|
| Study Overall Status Date and Time |
|
| Study Status |
|
| Study Stopped Reason |
|
| Relationship | |
 describingStudyOverallStatus |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Anticipated Ind
| Description | Specifies whether the overall status of the study is an estimate. |
| 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 |
Status Comment Txt
| Description | Additional description of the overall status of the study. |
| 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 |
Study Overall Status Date and Time
| Description | The date and time the comprehensive state of the study 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 |
Study Status
| Description | Specifies the phase in the lifecycle of the study as a whole. For example: In Review Approved Active Closed to Accrual Closed to Accrual and Intervention Temporary Closed to Accrual Temporary Closed to Accrual and Intervention Disapproved Withdrawn Administratively complete |
| 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 |
Study Stopped Reason
| Description | Specifies why the study has been halted or terminated (for suspended, terminated or withdrawn studies). |
| 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 |
describingStudyOverallStatus
| Description | |
| Is Identifying Relationship | false |
| Child Table | Study Overall Status |
| Child Role Name | describedStudyExecution |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | RESTRICT |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | RESTRICT |
| Parent Table | Study Execution |
| Parent Role Name | describingStudyOverallStatus |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | RESTRICT |
| Parent Referential Integrity: On Update | RESTRICT |
| Business Data Model Data Model |