| Business Data Model Data Model |
| Description | The state of a study at a particular facility as assigned by an oversight committee. For example: Request not submitted Submitted, pending Submitted, approved Submitted, exempt Submitted, denied Submission not required |
| Attributes | |
Review Board Approval Number Txt |
|
Review Board Process |
|
Review Board Process Date and Time |
|
| Relationship | |
assignedStudySiteOversightStatus |
|
| Dependencies | |
NONE |
|
| Reverse Dependencies | |
|
|
| Attribute Details |
Review Board Approval Number Txt
| Description | A character string that is assigned by the review board upon approval of the protocol. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Small [VARCHAR(50)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Review Board Process
| Description | Specifies the phase in the lifecycle of the review board process. For example: Request not submitted Submitted, pending Submitted, approved Submitted, exempt Submitted, denied Submission not required |
| 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 |
Review Board Process Date and Time
| Description | The date and time on which the Institutional Review Board (IRB) determine the status of the study for execution at the site. |
| 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 |
| Relationship Details |
assignedStudySiteOversightStatus
| Description | |
| Is Identifying Relationship | false |
| Child Table | Study Site Oversight Status |
| Child Role Name | assigningOversightCommittee |
| 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 | Oversight Committee |
| Parent Role Name | assignedStudySiteOversightStatus |
| 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 |