Entity Study Objective Detail

DescriptionA goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.

For example:
To extend the life of study participants by at least 3 years.
To determine efficacy of Drug X dose 1, dose 2, and dose 3 as measured by the percentage of subjects experiencing headache relief.

Attributes
Effective From DtEffective From Dt
Effective To DtEffective To Dt
Load Info SkLoad Info Sk
Objective DescrObjective Descr
Source Code SkSource Code Sk
Study Objective SkStudy Objective Sk
Tenant SkTenant Sk
Type Code SkType Code Sk
Valid From TsValid From Ts
Valid To TsValid To Ts

Relationship
Study Objective Detail_Study Objective_FKStudy Objective Detail_Study Objective_FK

Primary Key
Study Objective Detail PKStudy Objective Detail PK

Dependencies
 

Reverse Dependencies
 

Attribute Details

 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



 Objective Descr
DescriptionThe textual representation of the study objective.

For example:
The objective of the analysis is to evaluate the efficacy of study treatment versus placebo. The Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] and the Video-referenced Clinician's Interview-based Impression of Change (CIBIC+) will serve as the primary efficacy instruments. Efficacy will be determined by testing for a statistically significant relationship between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, low dose [54 mg], and high dose [81 mg]).
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
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



 Study Objective 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



 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



 Type Code Sk
DescriptionIdentifies the actual type of the entry based on the entity type hierarchy defined in the business data model.
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 Objective Detail_Study Objective_FK
Is Identifying Relationshiptrue
Child TableStudy Objective Detail
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableStudy Objective
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

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