Duration QtyLead Ind
| Business Data Model Data Model |
| Description | A facility in which study activities are intended to be conducted. For example: The site where the study subject encounter is intended to occur, or the site of the Investigator. |
| Attributes | |
| Duration Qty |
|
| Lead Ind |
|
| Relationship | |
 PlannedStudySite_Location_FK |
|
| PlannedStudySite_Organization_FK |
|
| Planned Study Site_Study_FK |
|
| executesStudyProtocol |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Duration Qty
| Description | The intended period of time for the planned 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 |
Lead Ind
| Description | Specifies whether this is the principal administrative organization intended to be 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 |
| Relationship Details |
PlannedStudySite_Location_FK
| Is Identifying Relationship | false |
| Child Table | Planned 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 |
PlannedStudySite_Organization_FK
| Is Identifying Relationship | false |
| Child Table | Planned 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 |
Planned Study Site_Study_FK
| Is Identifying Relationship | false |
| Child Table | Planned 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 | Study |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
executesStudyProtocol
| Is Identifying Relationship | false |
| Child Table | Planned 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 | Study Protocol |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Business Data Model Data Model |