| Atomic Warehouse 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. |
| Relationship | |
 Study Site Detail_Study Site_FK |
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| Primary Key | |
 Study Site Detail PK |
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| Dependencies | |
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| Reverse Dependencies | |
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| Attribute Details |
Accrual Status Code Sk
| 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/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Accrual Status Dt
| 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 |
Effective From Dt
| Description | Establishes a period where a set of attributes are true according to the business. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Effective To Dt
| Description | Ends a period of effectivity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
| 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 |
Load Info Sk
| Description | The surrogate key of the load information entry describing the details regarding the loading of the row. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| 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 |
Recruitment Status Code Sk
| Description | Specifies the phase in the lifecycle of recruitment for the study. For example: Not yet recruiting Recruiting Enrolling by invitation Active Not recruiting Completed Suspended Terminated Withdrawn. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Recruitment Status Dt
| Description | The date and time when the recruitment status for a study site 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 |
Source Code Sk
| Description | The origin of the data identifying the actual load source, vendor, manual key entry, or context of the data in a specific row in the database. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Status Code Sk
| Description | Specifies the phase in the lifecycle of the study site. For example: Pending Active Complete Cancelled |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Status Dt
| 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 |
Study Site Sk
| Description | Surrogate key for the anchor entity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
| Is Part Of PrimaryKey | true |
| Is Required | true |
| 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 |
Tenant Sk
| Description | The surrogate key of the entry identifying the legal owner of the data. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Valid From Ts
| Description | Establishes a period where a set of attributes are true in the source system. This would be populated with the transaction timestamp and would be used for the snapshot date. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| Is Part Of PrimaryKey | true |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Valid To Ts
| Description | Ends a period of validity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
Study Site Detail_Study Site_FK
| Is Identifying Relationship | true |
| Child Table | Study Site Detail |
| 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 | Study Site |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Primary Key Details |
Study Site Detail PK
| Key Attribute | Study Site Sk |
| Key Attribute | Valid From Ts |
| Atomic Warehouse Model Data Model |