Arm DescrArm NameArm TypeRandomization Weight RatioTarget Accrual Number Range Qty
| Business Data Model Data Model |
| Description | A 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 Descr |
|
| Arm Name |
|
| Arm Type |
|
| Randomization Weight Ratio |
|
| Target Accrual Number Range Qty |
|
| Relationship | |
 performedArm |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Arm Descr
| Description | The 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 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 |
Arm Name
| Description | A non-unique textual identifier for the arm. For example: Treatment A |
| 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 |
Arm Type
| Description | Specifies the kind of arm. For example: Experimental Active Comparator Placebo Comparator Sham Comparator No intervention |
| 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 |
Randomization Weight Ratio
| Description | The relative proportion of study subjects that are randomized to the arm. For example: If one, two or three study subjects are randomized to Arm A and two or three subjects to Arm B, then the values of randomization weight for Arms A and B, can be expressed as 1 and 2 or as 1/3 and 2/3. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Target Accrual Number Range Qty
| Description | An integer that specifies the number of study subjects to be accrued for the study or study arm, and can represent the minimum number of study subjects needed to support data analysis and the maximum number of study subjects that can be accrued to the study or study arm. |
| 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 |
| Relationship Details |
performedArm
| Description | DESCRIPTION: Each Experimental Unit might have performed one Arm. Each Arm might have been performed by one Experimental Unit. Indicates that an Experimental Unit was, at the end of their participation in a study, assigned to a particular arm based on their actual path through the study. This is derivable if the set of performed activities the Experimental Unit participated in are available. |
| Is Identifying Relationship | false |
| Child Table | Arm |
| Child Role Name | performingExperimentalUnit |
| Child Multiplicity | ZERO_TO_ONE |
| Child Referential Integrity: On Delete | SET_NULL |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | SET_NULL |
| Parent Table | Experimental Unit |
| Parent Role Name | performedArm |
| Parent Multiplicity | ZERO_TO_ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | SET_NULL |
| Parent Referential Integrity: On Update | SET_NULL |
| Business Data Model Data Model |