Blinded NameCharacteristic Modified IndExpanded Access IndFirst In Human IndFirst In Human Risk FactorPediatric Formulation IndStudy Agent FunctionStudy Agent StatusStudy Agent Status Date and TimeSubstitution Allowed Ind
| Business Data Model Data Model |
| Description | A product that is being used or tested as part of a study. For example: Tamoxifen used in a breast cancer study. Fish oil used in a heart health study. Artificial knee joints used in a joint replacement study. |
| Relationship | |
 performedStudyAgent |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Blinded Name
| Description | Text description of the study agent to be used by participants from whom the identity of the study agent is not known. For example: In a study for which the study agents are a drug product and a matching placebo, both the active product and the placebo might simply be called "Study Drug." In a study with two different investigational products and their matching placebos, the blinded names might be "Bottle A" and "Bottle B". |
| 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 |
Characteristic Modified Ind
| Description | Specifies whether the agent's characteristic have been modified from those approved in the marketing authorization in a way that could affect its quality. Modification may include a change in pharmaceutical form (for example, over-encapsulation, color, dilution, re-tabletting for blinding etc.) or removal from the primary packaging and repacking (for example, removal from a blister and putting in a bottle). |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Expanded Access Ind
| Description | Specifies whether the product (drug or device) is available for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled study. Expanded Access is a mechanism that provides non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
First In Human Ind
| Description | Specifies whether this is the first time an active substance of the agent is to be administered to humans in a study. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
First In Human Risk Factor
| Description | Specifies the risk factors identified with administering the agent's active substance to humans for the first time in a study. |
| 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 |
Pediatric Formulation Ind
| Description | Specifies whether the pharmaceutical form of the agent is intended for pediatric usage. For example: A value of true may indicate that the agent is dissolvable, smaller, or grape flavored to be easily ingested by the pediatric population. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Study Agent Function
| Description | Specifies how this agent is used in the study. This is important to know in multi-agent studies. For example: Lead agent Comparator agent Placebo Active control |
| 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 |
Study Agent Status
| Description | The phase in the lifecycle of the agent's association to a study. For example: Pending Active Complete Canceled |
| 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 |
Study Agent Status Date and Time
| Description | The date and time the status/phase in the lifecycle of the agent's association to a study is defined. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Substitution Allowed Ind
| Description | Specifies whether this agent as identified by its active substance is permitted to be substituted by a local brand. For example: The study protocol may specify the use of Paracetamol which could be substituted locally in the United States with any brand containing acetaminophen, including Tylenol and Panadol. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
performedStudyAgent
| Is Identifying Relationship | false |
| Child Table | Study Agent |
| Child Role Name | performingProduct |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | RESTRICT |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | RESTRICT |
| Parent Table | Product |
| Parent Role Name | performedStudyAgent |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | RESTRICT |
| Parent Referential Integrity: On Update | RESTRICT |
| Business Data Model Data Model |