Accepts Healthy Volunteers IndAllocation MethodBlinded RoleBlinding SchemaControl Concurrency TypeControl TypeData Monitoring Committee IndIntervention DescrIntervention Group QtyIntervention Type CodeStudy Agent Randomization Fraction
| Business Data Model Data Model |
| Description | A study protocol for a pre-clinical or clinical study in which study subjects or experimental units are assigned by an investigator based on a protocol to receive specific interventions. Study subjects or experimental units may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The study subjects or experimental units are then followed and biomedical and/or health outcomes are assessed. |
| Generalization | |
 R_1463 |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
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| Attribute Details |
Accepts Healthy Volunteers Ind
| Description | Specifies whether persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the 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 |
Allocation Method
| Description | Identifies the method of assigning experimental units to treatment or control groups. For example: n/a Randomized controlled study Non-randomized 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 |
Blinded Role
| Description | Identifies the roles of individuals who are masked for single or double blind studies. For example: Subject Caregiver Investigator Outcomes assessor |
| 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 |
Blinding Schema
| Description | Specifies the type of masking used on a study protocol to ensure that the results are not biased by the study subjects or investigators. Double-blinded would indicate that both the investigator and the study subject would not know whether the intervention was a placebo or an active therapeutic intervention. For example: Open Label Double Blind Single Blind |
| 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 |
Control Concurrency Type
| Description | Specifies the temporal relationships of the control to the study intervention. For example: Concurrent Historical Pre/post (patient owned 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 |
Control Type
| Description | Specifies the kind of comparison or comparator against which the study treatment is evaluated. For example: Placebo Active Historical Uncontrolled Dose comparison |
| 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 |
Data Monitoring Committee Ind
| Description | Specifies whether a data monitoring committee is appointed to the 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 |
Intervention Descr
| Description | A character string that provides the key details of the intervention. For example: The details can distinguish between: - Arms of a study (for example, comparison of different dosages of drug) -Among similar interventions (for example, comparison of multiple implantable cardiac defibrillators) |
| 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 |
Intervention Group Qty
| Description | An integer that specifies the number of intervention groups. For example: 1 for single-arm study |
| 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 |
Intervention Type Code
| Description | A coded value specifying the kind of intervention being studied. For example: Drug Radiation Lifestyle |
| 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 Randomization Fraction
| Description | A number representing the quantity of study subjects in the overall study who receive at least one study agent (as opposed to placebo) divided by the quantity of subjects in the study overall - independent of dosage or other protocol variations. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Percentage [FLOAT(2)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Generalization Details |
R_1463
| Supertype | Study Protocol |
| Subtype | Interventional Study Protocol |
| Transform As | TABLE |
| Business Data Model Data Model |