`spark_auto_mapper_fhir.value_sets.research_study_phase`¶

Module Contents¶

`ResearchStudyPhaseCode`	ResearchStudyPhase
`ResearchStudyPhaseCodeValues`	Trials without phases (for example, studies of devices or behavioral

class spark_auto_mapper_fhir.value_sets.research_study_phase.ResearchStudyPhaseCode(value)¶

Codes for the stage in the progression of a therapy from initial experimental

use in humans in clinical trials to post-market evaluation.

Parameters: value (spark_auto_mapper.type_definitions.defined_types.AutoMapperTextInputType) –

codeset :spark_auto_mapper_fhir.fhir_types.uri.FhirUri = http://terminology.hl7.org/CodeSystem/research-study-phase¶

class spark_auto_mapper_fhir.value_sets.research_study_phase.ResearchStudyPhaseCodeValues¶

Trials without phases (for example, studies of devices or behavioral interventions). From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

N_A¶: Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration’s (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

EarlyPhase1¶: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

Phase1¶: Trials that are a combination of phases 1 and 2. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

Phase1_Phase2¶: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

Phase2¶: Trials that are a combination of phases 2 and 3. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

Phase2_Phase3¶: Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml

Phase3¶: Studies of FDA-approved drugs to delineate additional information including the drug’s risks, benefits, and optimal use. From: http://terminology.hl7.org/CodeSystem/research-study-phase in valuesets.xml