Entity Arm Detail

DescriptionA path through the study that describes what activities the study subject or experimental unit will be involved in as they pass through the study.

For example:
A study could have 2 arms named IV-Oral and Oral-IV. The name IV-Oral reflects a path that passes through IV treatment, then Oral treatment.

Attributes
Arm DescrArm Descr
Arm NmArm Nm
Arm SkArm Sk
Effective From DtEffective From Dt
Effective To DtEffective To Dt
Load Info SkLoad Info Sk
Randomization Weight RatioRandomization Weight Ratio
Source Code SkSource Code Sk
Target Accrual Number Range QtyTarget Accrual Number Range Qty
Tenant SkTenant Sk
Type Code SkType Code Sk
Valid From TsValid From Ts
Valid To TsValid To Ts

Relationship
Arm Detail_Arm_FKArm Detail_Arm_FK

Primary Key
Arm Detail PKArm Detail PK

Dependencies
 

Reverse Dependencies
 

Attribute Details

 Arm Descr
DescriptionThe textual representation of the arm. This is a description of the pathway followed by all subjects, study subjects, or experimental units in a particular treatment regimen.

For example:
Study subjects receive Drug X
Experimental units receive Placebo
Study subjects receive drug A IV in the first phase, drug B Oral in the second phase
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Arm Nm
DescriptionA non-unique textual identifier for the arm.

For example:
Treatment A
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Arm 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



 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



 Randomization Weight Ratio
DescriptionThe relative proportion of study subjects to be randomized to the arm.

For example:
If 1/3 of study subjects are to be randomized to Arm A and 2/3 to Arm B, then the values of randomization weight for Arms A and B, respectively, could be expressed as 1 and 2 or as 1/3 and 2/3.
Data TypeStandards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)]
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



 Target Accrual Number Range Qty
DescriptionAn integer falling within minimum and maximum bounds that specifies how many study subjects are to be accrued for the arm. This may represent the minimum number of study subjects needed to support data analysis and/or the maximum number of study subjects that may be accrued to this arm.
Data TypeStandards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
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



 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

 Arm Detail_Arm_FK
Is Identifying Relationshiptrue
Child TableArm Detail
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableArm
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

 Arm Detail PK
Key AttributeArm Sk
Key AttributeValid From Ts