Confidentiality IndPayment MethodPlanned Subject QtyStudy Subject StatusStudy Subject Status Date and TimeSubject Id
| Business Data Model Data Model |
| Description | A subject that is potentially available for research studies. A patient study subject is also known as a research version of the patient, housing none of the patients identifying information. For example: A person who is registered in a study as a recipient of an investigational product or as a control. Individuals who are being screened for studies. Individuals participating in observational or other studies. A pacemaker. A fuse that can be used in medical devices. A cow. A pen of pigs. A tissue sample from a tissue bank. |
| Attributes | |
| Confidentiality Ind |
|
| Payment Method |
|
| Planned Subject Qty |
|
| Study Subject Status |
|
| Study Subject Status Date and Time |
|
| Subject Id |
|
| Relationship | |
 Subject_Patient_FK |
|
| Study Subject_Genotype_FK |
|
| Study Subject_Haplotype_FK |
|
| Study Subject_Study_FK |
|
| Study Subject_Population_FK |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Confidentiality Ind
| Description | Specifies whether the study subject, or their legally acceptable representative, has not authorized the use and disclosure of their protected health information (that is, the study subject's data is private and confidential). |
| 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 |
Payment Method
| Description | Specifies the primary payer/insurance carrier information at the time of treatment on a study. For example: Private Insurance Medicare Medicare And Private Insurance Medicaid |
| 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 |
Planned Subject Qty
| Description | An integer falling within minimum and maximum bounds that specifies how many of a particular type of subject are planned to be included 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 Subject Status
| Description | Identifies the status that can be associated with an individual subject in a cohort. For example: Consented Qualified Treatment phase Post treatment Active Disqualified. |
| 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 Subject Status Date and Time
| Description | The date and time a status is assigned to an individual participating in the study. |
| 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 |
Subject Id
| Description | A unique reference code or number that establishes identity of the study subject. This can originate from an external system or be created by the data warehouse and it may be published to the research community. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Identifier [VARCHAR(80)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
Subject_Patient_FK
| Is Identifying Relationship | false |
| Child Table | Study Subject |
| 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 | Patient |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Study Subject_Genotype_FK
| Is Identifying Relationship | false |
| Child Table | Study Subject |
| 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 | Genotype |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Study Subject_Haplotype_FK
| Is Identifying Relationship | false |
| Child Table | Study Subject |
| 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 | Haplotype |
| Parent Multiplicity | ZERO_TO_MANY |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Study Subject_Study_FK
| Is Identifying Relationship | false |
| Child Table | Study Subject |
| 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 | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
Study Subject_Population_FK
| Is Identifying Relationship | false |
| Child Table | Study Subject |
| 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 | Population |
| 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 |