Terminology

CodeSystem:ResearchStudyStatus

Codes that convey the current status of the research study.
CodeDisplayDefinition
activeActiveStudy is opened for accrual.
administratively-completedAdministratively CompletedStudy is completed prematurely and will not resume; patients are no longer examined nor treated. Tagged.
approvedApprovedProtocol is approved by the review board.
closed-to-accrualClosed to AccrualStudy is closed for accrual; patients can be examined and treated.
closed-to-accrual-and-interventionClosed 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.
completedCompletedStudy 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.
disapprovedDisapprovedProtocol was disapproved by the review board.
in-reviewIn ReviewProtocol is submitted to the review board for approval.
temporarily-closed-to-accrualTemporarily Closed to AccrualStudy is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated.
temporarily-closed-to-accrual-and-interventionTemporarily Closed to Accrual and InterventionStudy is temporarily closed for accrual and intervention and potentially can be resumed in the future.
withdrawnWithdrawnProtocol was withdrawn by the lead organization.

CodeSystem:ResearchSubjectStatus

Indicates the progression of a study subject through a study.
CodeDisplayDefinition
candidateCandidateAn identified person that can be considered for inclusion in a study.
eligibleEligibleA person that has met the eligibility criteria for inclusion in a study.
follow-upFollow-upA person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule.
ineligibleIneligibleA person who did not meet one or more criteria required for participation in a study is considered to have failed screening or is ineligible for the study.
not-registeredNot RegisteredA person for whom registration was not completed.
off-studyOff-studyA person that has ended their participation on a study either because their treatment/observation is complete or through not responding, withdrawal, non-compliance and/or adverse event.
on-studyOn-studyA person that is enrolled or registered on a study.
on-study-interventionOn-study-interventionThe person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.
on-study-observationOn-study-observationThe subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is "short-term follow-up".
pending-on-studyPending on-studyA person is pre-registered for a study.
potential-candidatePotential CandidateA person that is potentially eligible for participation in the study.
screeningScreeningA person who is being evaluated for eligibility for a study.
withdrawnWithdrawnThe person has withdrawn their participation in the study before registration.

CodeSystem:ResearchStudyPrimaryPurposeType

Codes for the main intent of the study.
CodeDisplayDefinition
treatmentTreatmentOne or more interventions are being evaluated for treating a disease, syndrome, or condition.
preventionPreventionOne or more interventions are being assessed for preventing the development of a specific disease or health condition.
diagnosticDiagnosticOne or more interventions are being evaluated for identifying a disease or health condition.
supportive-careSupportive CareOne or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.
screeningScreeningOne 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.
health-services-researchHealth Services ResearchOne or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.
basic-scienceBasic ScienceOne or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
device-feasibilityDevice 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.

CodeSystem:ResearchStudyPhase

Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
CodeDisplayDefinition
n-aN/ATrials without phases (for example, studies of devices or behavioral interventions).
early-phase-1Early 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.
phase-1Phase 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.
phase-1-phase-2Phase 1/Phase 2Trials that are a combination of phases 1 and 2.
phase-2Phase 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.
phase-2-phase-3Phase 2/Phase 3Trials that are a combination of phases 2 and 3.
phase-3Phase 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.
phase-4Phase 4Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.

CodeSystem:ResearchStudyReasonStopped

Codes for why the study ended prematurely.
CodeDisplayDefinition
accrual-goal-metAccrual Goal MetThe study prematurely ended because the accrual goal was met.
closed-due-to-toxicityClosed due to toxicityThe study prematurely ended due to toxicity.
closed-due-to-lack-of-study-progressClosed due to lack of study progressThe study prematurely ended due to lack of study progress.
temporarily-closed-per-study-designTemporarily closed per study designThe study prematurely ended temporarily per study design.

CodeSystem:ResearchStudyObjectiveType

Codes for the kind of study objective.
CodeDisplayDefinition
primaryPrimaryThe 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.
secondarySecondaryQuestion to be answered in the study that is of lesser importance than the primary objective.
exploratoryExploratoryExploratory questions to be answered in the study.

ValueSet: ResearchStudyStatus

Codes that convey the current status of the research study.

ValueSet: ResearchStudyPhase

Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

ValueSet: ResearchStudyObjectiveType

Codes for the kind of study objective.

ValueSet: ResearchSubjectStatus

Indicates the progression of a study subject through a study.

ValueSet: ResearchStudyReasonStopped

Codes for why the study ended prematurely.

ValueSet: ResearchStudyPrimaryPurposeType

Codes for the main intent of the study.