Epoch DescrEpoch NameEpoch TypePriority SequenceTarget Accrual Range Qty
| Business Data Model Data Model |
| Description | One 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 | |
| Epoch Descr |
|
| Epoch Name |
|
| Epoch Type |
|
| Priority Sequence |
|
| Target Accrual Range Qty |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Epoch Descr
| Description | The 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 Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Epoch Name
| Description | A non-unique textual identifier for the epoch. For example: First treatment epoch Second treatment epoch First wash-out epoch Second wash-out epoch |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Epoch Type
| Description | Specifies the kind of epoch. For example: Screening Treatment Follow-up |
| 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 |
Priority Sequence
| Description | An 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 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 |
Target Accrual Range Qty
| Description | An integer falling within minimum and maximum bounds that specifies how many study subjects to be accrued for the epoch. |
| 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 |
| Business Data Model Data Model |