Entity Epoch Detail

DescriptionOne of a set of ordered partitions of a subject's, study subject's or experimental unit's participation in a study. An Epoch represents a state within a study such that subjects in separate arms within that state are comparable. Each epoch serves a purpose in the study as a whole, typically exposing the subject to a treatment or preparing them for a treatment, or gathering post-treatment data. Activities and activity results control the subject's movement from one epoch to another.

For example:
A study designed to assess the effects of treatments might have 3 epochs as follows:
A Screening Epoch in which subjects' eligibility is determined and baseline measurements are made.
A Treatment Epoch during which treatments are given and effects of treatment are assessed.
A Follow-up Epoch during which post-treatment assessments are conducted.

Attributes
Effective From DtEffective From Dt
Effective To DtEffective To Dt
Epoch DescrEpoch Descr
Epoch NmEpoch Nm
Epoch SkEpoch Sk
Load Info SkLoad Info Sk
Priority SequencePriority Sequence
Source Code SkSource Code Sk
Target Accrual Range QtyTarget Accrual Range Qty
Tenant SkTenant Sk
Type Code SkType Code Sk
Valid From TsValid From Ts
Valid To TsValid To Ts

Relationship
Epoch Detail_Epoch_FKEpoch Detail_Epoch_FK

Primary Key
Epoch Detail PKEpoch 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



 Epoch Descr
DescriptionThe textual representation of the epoch.

For example:
"A 2-week period during which eligibility is determined and baseline measurements are taken".

"The first treatment epoch is a one-week period during which a single dose of one of the three investigational treatments is administered".
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Epoch Nm
DescriptionA non-unique textual identifier for the epoch.

For example:
First treatment epoch
Second treatment epoch
First wash-out epoch
Second wash-out epoch
Data TypeStandards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Epoch 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



 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



 Priority Sequence
DescriptionAn integer specifying the relative sequential or temporal ordering of this epoch among other similar epochs in a study.

For example:
In a Study that has Screening, Treatment and Follow-Up epochs, the sequence number indicates which Epoch precedes the other.
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



 Target Accrual Range Qty
DescriptionAn integer falling within minimum and maximum bounds that specifies how many study subjects to be accrued for the epoch.
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

 Epoch Detail_Epoch_FK
Is Identifying Relationshiptrue
Child TableEpoch Detail
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableEpoch
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

 Epoch Detail PK
Key AttributeEpoch Sk
Key AttributeValid From Ts