| Business Data Model Data Model |
Description | A study protocol for a pre-clinical or clinical study in which biomedical and/or health outcomes are assessed in pre-defined groups of study subjects or experimental units. Study subjects or experimental units in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study subjects or experimental units of the study. |
Attributes | |
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Generalization | |
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Dependencies | |
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Reverse Dependencies | |
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Attribute Details |
Description | Specifies the process used to define a representative set of a population for a study. For example: A Probability Sample: exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive patient sampling. A Non-Probability Sample: any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer. |
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 |
Description | Specifies whether any biological specimen has the potential for DNA extraction. Specimens with the potential for DNA extraction include frozen tissue and whole blood whereas specimens without the potential for DNA extraction include fixed tissue and plasma. |
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 |
Description | Specifies whether a biological specimen is retained beyond the duration of 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 |
Description | Specifies the temporal relationship of observation period to time of subject enrollment. For example: Prospective Retrospective Cross-sectional |
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 |
Generalization Details |
Supertype | Study Protocol |
Subtype | Observational Study Protocol |
Transform As | TABLE |
| Business Data Model Data Model |