Entity Observational Study Protocol

DescriptionA 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
Sampling MethodSampling Method
Specimen Available For DNA Extraction IndSpecimen Available For DNA Extraction Ind
Specimen Retention IndSpecimen Retention Ind
Study Time PerspectiveStudy Time Perspective

Generalization
R_1465R_1465

Dependencies
 NONE

Reverse Dependencies
 

Attribute Details

 Sampling Method
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Specimen Available For DNA Extraction Ind
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Specimen Retention Ind
DescriptionSpecifies whether a biological specimen is retained beyond the duration of the study.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Study Time Perspective
DescriptionSpecifies the temporal relationship of observation period to time of subject enrollment.

For example:
Prospective
Retrospective
Cross-sectional
Data TypeStandards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse

Generalization Details

 R_1465
SupertypeStudy Protocol
SubtypeObservational Study Protocol
Transform AsTABLE