Accrual StatusAccrual Status Date and TimeDate Range QtyIdentification NumLead IndPlanned Duration QtyStudy Site StatusStudy Site Status Date and TimeTarget Accrual Range
| Business Data Model Data Model |
| Description | A facility in which study activities are conducted. For example: The site where the study subject encounter occurs, or the site of the Investigator. |
| Attributes | |
| Accrual Status |
|
| Accrual Status Date and Time |
|
| Date Range Qty |
|
| Identification Num |
|
| Lead Ind |
|
| Planned Duration Qty |
|
| Study Site Status |
|
| Study Site Status Date and Time |
|
| Target Accrual Range |
|
| Relationship | |
 executingStudySite |
|
| StudySite_Location_FK |
|
| StudySite_Organization_FK |
|
| StudySite_Trial Resource_FK |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Accrual Status
| Description | A coded value specifying the phase in the lifecycle of a participating site relative to the enrollment of additional experimental units in the given study. For example: Open to accrual Closed to accrual Temporarily closed to accrual Pending accrual |
| 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 |
Accrual Status Date and Time
| Description | The date and time on which the accrual status is established. |
| 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 |
Date Range Qty
| Description | The date and time span specifying when the site's participation in the study begins and ends. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| 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 study site. |
| 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 |
Lead Ind
| Description | Specifies whether this is the principal administrative organization responsible for the study. Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization. |
| 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 |
Planned Duration Qty
| Description | The intended period of time for the study site's participation in the study. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Study Site Status
| Description | The phase in the lifecycle of the study site. For example: Pending Active Complete Canceled |
| 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 Site Status Date and Time
| Description | The date and time the status/phase in the lifecycle of the site's association to 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 |
Target Accrual Range
| Description | An integer falling within minimum and maximum bounds that specifies how many experimental units are needed for enrollment at this site. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
executingStudySite
| Description | |
| Is Identifying Relationship | false |
| Child Table | Study Site |
| Child Role Name | executedStudyExecution |
| 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 | Study Execution |
| Parent Role Name | executingStudySite |
| 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 |
StudySite_Location_FK
| Is Identifying Relationship | false |
| Child Table | Study Site |
| 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 | Location |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
StudySite_Organization_FK
| Is Identifying Relationship | false |
| Child Table | Study Site |
| 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 | Organization |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
StudySite_Trial Resource_FK
| Is Identifying Relationship | false |
| Child Table | Study Site |
| 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 | Trial Resource |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Business Data Model Data Model |