Entity Study Subject Detail

DescriptionA 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 IndConfidentiality Ind
Effective From DtEffective From Dt
Effective To DtEffective To Dt
Load Info SkLoad Info Sk
Payment Method Code SkPayment Method Code Sk
Planned Subject QtyPlanned Subject Qty
Source Code SkSource Code Sk
Status Code SkStatus Code Sk
Study Subject SkStudy Subject Sk
Subject Id NumSubject Id Num
Tenant SkTenant Sk
Valid From TsValid From Ts
Valid To TsValid To Ts

Relationship
Study Subject Detail_Study Subject_FKStudy Subject Detail_Study Subject_FK

Primary Key
Study Subject Detail PKStudy Subject Detail PK

Dependencies
 

Reverse Dependencies
 

Attribute Details

 Confidentiality Ind
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Effective From Dt
DescriptionEstablishes a period where a set of attributes are true according to the business.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Effective To Dt
DescriptionEnds a period of effectivity.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Load Info Sk
DescriptionThe surrogate key of the load information entry describing the details regarding the loading of the row.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Payment Method Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Planned Subject Qty
DescriptionAn 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 TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Source Code Sk
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Status Code Sk
DescriptionIdentifies the status that can be associated with an individual subject in a cohort. 

For example:
Consented
Qualified
Treatment phase
Post treatment
Active
Disqualified.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Subject Sk
DescriptionSurrogate key for the anchor entity.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeytrue
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Subject Id Num
DescriptionA 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 TypeStandards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Tenant Sk
DescriptionThe surrogate key of the entry identifying the legal owner of the data.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Valid From Ts
DescriptionEstablishes 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 TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeytrue
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Valid To Ts
DescriptionEnds a period of validity.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse

Relationship Details

 Study Subject Detail_Study Subject_FK
Is Identifying Relationshiptrue
Child TableStudy Subject Detail
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Subject
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

 Study Subject Detail PK
Key AttributeStudy Subject Sk
Key AttributeValid From Ts