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4.3.16.341 Code System http://hl7.org/fhir/research-study-classifiers

Biomedical Research and Regulation Work Group Maturity Level: 0Trial Use Use Context: Any

This is a code system defined by the FHIR project.

Summary

Defining URL:http://hl7.org/fhir/research-study-classifiers
Version:4.6.0
Name:ResearchStudyClassifiers
Title:ResearchStudy Classifiers Code System
Definition:

Codes for use in ResearchStudy Resource. This resource (this entire set of content) is being used for active development of a ResearchStudyClassifiers CodeSystem for use for supporting multiple value sets in the FHIR ResearchStudy StructureDefinition.

Committee:Biomedical Research and Regulation Work Group
OID:2.16.840.1.113883.4.642.1.1686 (for OID based terminology systems)
Source ResourceXML / JSON

This Code system is used in the following value sets:

This code system http://hl7.org/fhir/research-study-classifiers defines the following codes:

LvlCodeDisplayDefinition
1research-study-label-type Research Study Label Type
2  short ShortA short form of the name - what is used in everyday conversation.
2  public PublicA name that is understandable to non-technical readers.
2  scientific ScientificA full name that is suitable for use in an academic or technical setting.
1research-study-classifier Research Study Classifier
2  research-study-prim-purp-type Research Study Primary Purpose Type
3    treatment TreatmentOne or more interventions are being evaluated for treating a disease, syndrome, or condition.
3    prevention PreventionOne or more interventions are being assessed for preventing the development of a specific disease or health condition.
3    diagnostic DiagnosticOne or more interventions are being evaluated for identifying a disease or health condition.
3    supportive-care Supportive CareOne or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.
3    screening ScreeningOne or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor.
3    health-services-research Health Services ResearchOne or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.
3    basic-science Basic ScienceOne or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
3    device-feasibility Device FeasibilityAn intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
2  research-study-phase Research Study Phase
3    n-a N/ATrials without phases (for example, studies of devices or behavioral interventions).
3    early-phase-1 Early Phase 1Designation 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.
3    phase-1 Phase 1Includes 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.
3    phase-1-phase-2 Phase 1/Phase 2Trials that are a combination of phases 1 and 2.
3    phase-2 Phase 2Includes 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.
3    phase-2-phase-3 Phase 2/Phase 3Trials that are a combination of phases 2 and 3.
3    phase-3 Phase 3Includes 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.
3    phase-4 Phase 4Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
2  research-study-focus-type Research Study Focus Type
3    medication Medication
3    device Device
3    intervention Intervention
3    factor Factor
1research-study-classification-type Research Study Classification Type
2  phase Phase
2  category Category
2  keyword Keyword
1research-study-party-organization-type Research Study Party Organization Type
2  nih NIH
2  fda FDA
1research-study-party-role Research Study Party Role
2  sponsor Sponsor
2  lead-sponsor Lead Sponsor
2  sponsor-investigator Sponsor-Investigator
2  primary-investigator Primary Investigator
2  collaborator Collaborator
2  funding-source Funding Source
2  recruitment-contact Recruitment Contact
2  sub-investigator Sub-investigator
2  study-director Study Director
2  study-chair Study Chair
1research-study-status Research Study Status
2  active ActiveStudy is opened for accrual.
2  active-but-not-recruiting Active, not recruitingThe study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
2  administratively-completed Administratively CompletedStudy is completed prematurely and will not resume; patients are no longer examined nor treated.
2  approved ApprovedProtocol is approved by the review board.
2  closed-to-accrual Closed to AccrualStudy is closed for accrual; patients can be examined and treated.
2  closed-to-accrual-and-intervention Closed to Accrual and InterventionStudy is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study.
2  completed CompletedThe study closed according to the study plan. There will be no further treatments, interventions or data collection.
2  disapproved DisapprovedProtocol was disapproved by the review board.
2  enrolling-by-invitation Enrolling by invitationThe study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
2  in-review In ReviewProtocol is submitted to the review board for approval.
2  not-yet-recruiting Not yet recruitingThe study has not started recruiting participants.
2  recruiting RecruitingThe study is currently recruiting participants.
2  temporarily-closed-to-accrual Temporarily Closed to AccrualStudy is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated.
2  temporarily-closed-to-accrual-and-intervention Temporarily Closed to Accrual and InterventionStudy is temporarily closed for accrual and intervention and potentially can be resumed in the future.
2  terminated TerminatedThe study has stopped early and will not start again. Participants are no longer being examined or treated.
2  withdrawn WithdrawnProtocol was withdrawn by the lead organization.
1research-study-statusDate-activity Research Study Status-related Activity
2  record-verification Record VerificationRecord has been verified.
2  overall-study Overall study
2  primary-outcome-data-collection Primary outcome data collection
2  registration-submission Registration submission
2  registration-submission-qc Registration submission Quality Check
2  registration-posting Registration posting
2  results-submission Results submission
2  results-submission-qc Results submission Quality Check
2  results-posting Results posting
2  disposition-submission Disposition submission
2  disposition-submission-qc Disposition submission Quality Check
2  disposition-posting Disposition posting
2  update-submission Update submission
2  update-posting Update posting
1research-study-reason-stopped Research Study Reason Stopped
2  accrual-goal-met Accrual Goal MetThe study prematurely ended because the accrual goal was met.
2  closed-due-to-toxicity Closed due to toxicityThe study prematurely ended due to toxicity.
2  closed-due-to-lack-of-study-progress Closed due to lack of study progressThe study prematurely ended due to lack of study progress.
2  temporarily-closed-per-study-design Temporarily closed per study designThe study prematurely ended temporarily per study design.
1research-study-objective-type Research Study Objective Type
2  primary PrimaryThe main question to be answered, and the one that drives any statistical planning for the study—e.g., calculation of the sample size to provide the appropriate power for statistical testing.
2  secondary SecondaryQuestion to be answered in the study that is of lesser importance than the primary objective.
2  exploratory ExploratoryExploratory questions to be answered in the study.
1research-study-arm-type Research Study Arm Type
2  active-comparator Active Comparator
2  placebo-comparator Placebo Comparator
2  sham-comparator Sham Comparator
2  no-intervention No Intervention
2  experimental Experimental
2  other-arm-type Other Arm Type

 

See the full registry of code systems defined as part of FHIR.


Explanation of the columns that may appear on this page:

LevelA few code lists that FHIR defines are hierarchical - each code is assigned a level. See Code System for further information.
SourceThe source of the definition of the code (when the value set draws in codes defined elsewhere)
CodeThe code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')
DisplayThe display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
DefinitionAn explanation of the meaning of the concept
CommentsAdditional notes about how to use the code