4.3.2.347 CodeSystem http://hl7.org/fhir/research-study-classifiers

Biomedical Research and Regulation Work Group

Maturity Level: 0

Trial Use

Use Context: Country: World, Country: World

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This Code system is used in the following value sets:

• ValueSet: ResearchStudyPrimaryPurposeType (Codes for the main intent of the 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: ResearchStudyFocusType (Codes for the main intent of the study.)
• ValueSet: Research Study Classifiers (Codes that convey the type of label that is provided.)
• ValueSet: Research Study Party Role (This is a ResearchStudy's party role.)
• ValueSet: Research Study Party Organization Type (This is a ResearchStudy's party organization type.)
• ValueSet: ResearchStudyStatus (Codes that convey the current status of the research study.)
• ValueSet: ResearchStudyReasonStopped (Codes for why the study ended prematurely.)
• ValueSet: ResearchStudyArmType (Codes for the main intent of the study.)
• ValueSet: ResearchStudyObjectiveType (Codes for the kind of study objective.)
• ValueSet: ResearchStudyRegistrationActivity (Codes for study registration activities.)
• ValueSet: Study Design (This is a set of terms for study design characteristics.)

4.3.2.347.1 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.

4.3.2.347.2 Content

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

Lvl	Code	Display	Definition	Copy
1	research-study-prim-purp-type	Research Study Primary Purpose Type
2	treatment	Treatment	One or more interventions are being evaluated for treating a disease, syndrome, or condition.
2	prevention	Prevention	One or more interventions are being assessed for preventing the development of a specific disease or health condition.
2	diagnostic	Diagnostic	One or more interventions are being evaluated for identifying a disease or health condition.
2	supportive-care	Supportive Care	One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.
2	screening	Screening	One 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.
2	health-services-research	Health Services Research	One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.
2	basic-science	Basic Science	One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
2	device-feasibility	Device Feasibility	An 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.
1	research-study-phase	Research Study Phase
2	n-a	N/A	Trials without phases (for example, studies of devices or behavioral interventions).
2	early-phase-1	Early Phase 1	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.
2	phase-1	Phase 1	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.
2	phase-1-phase-2	Phase 1/Phase 2	Trials that are a combination of phases 1 and 2.
2	phase-2	Phase 2	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.
2	phase-2-phase-3	Phase 2/Phase 3	Trials that are a combination of phases 2 and 3.
2	phase-3	Phase 3	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.
2	phase-4	Phase 4	Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
1	research-study-focus-type	Research Study Focus Type
2	medication	Medication
2	device	Device
2	intervention	Intervention
2	factor	Factor
1	research-study-classifier	Research Study Classifier
2	fda-regulated-drug	FDA regulated drug	A medication regulated by the U.S. Food and Drug Administration.
2	fda-regulated-device	FDA regulated device	A medical device regulated by the U.S. Food and Drug Administration.
2	mpg-paragraph-23b	MPG Paragraph 23b	Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).
2	irb-exempt	IRB-exempt	Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).
1	research-study-party-organization-type	Research Study Party Organization Type
2	nih	NIH
2	fda	FDA
2	government	Government
2	nonprofit	Nonprofit
2	academic	Academic
2	industry	Industry
1	research-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	general-contact	General Contact
2	recruitment-contact	Recruitment Contact
2	sub-investigator	Sub-investigator
2	study-director	Study Director
2	study-chair	Study Chair
1	research-study-status	Research Study Status
2	overall-study	Overall study	Used for documenting the start and end of the overall study, distinct from progress states.
2	active	Active	Study is opened for accrual.
2	active-but-not-recruiting	Active, not recruiting	The 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 Completed	Study is completed prematurely and will not resume; patients are no longer examined nor treated.
2	approved	Approved	Protocol is approved by the review board.
2	closed-to-accrual	Closed to Accrual	Study is closed for accrual; patients can be examined and treated.
2	closed-to-accrual-and-intervention	Closed to Accrual and Intervention	Study 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	Completed	The study closed according to the study plan. There will be no further treatments, interventions or data collection.
2	disapproved	Disapproved	Protocol was disapproved by the review board.
2	enrolling-by-invitation	Enrolling by invitation	The 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 Review	Protocol is submitted to the review board for approval.
2	not-yet-recruiting	Not yet recruiting	The study has not started recruiting participants.
2	recruiting	Recruiting	The study is currently recruiting participants.
2	temporarily-closed-to-accrual	Temporarily Closed to Accrual	Study 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 Intervention	Study is temporarily closed for accrual and intervention and potentially can be resumed in the future.
2	terminated	Terminated	The study has stopped early and will not start again. Participants are no longer being examined or treated.
2	withdrawn	Withdrawn	Protocol was withdrawn by the lead organization.
1	research-study-registration-activity	Research Study Registration Activity
2	record-verification	Record Verification	Record has been verified.
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
1	research-study-reason-stopped	Research Study Reason Stopped
2	accrual-goal-met	Accrual Goal Met	The study prematurely ended because the accrual goal was met.
2	closed-due-to-toxicity	Closed due to toxicity	The study prematurely ended due to toxicity.
2	closed-due-to-lack-of-study-progress	Closed due to lack of study progress	The study prematurely ended due to lack of study progress.
2	temporarily-closed-per-study-design	Temporarily closed per study design	The study prematurely ended temporarily per study design.
1	research-study-objective-type	Research Study Objective Type
2	primary	Primary	The 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	Secondary	Question to be answered in the study that is of lesser importance than the primary objective.
2	exploratory	Exploratory	Exploratory questions to be answered in the study.
1	research-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
1	SEVCO:01000	Study Design	A plan specification for how and what kinds of data will be gathered as part of an investigation which may produce testable explanations, conclusions and predictions or test a hypothesis.
2	SEVCO:01001	Interventional research	A study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by the investigator to evaluate a response in the dependent variable (an effect or outcome).
3	SEVCO:01003	randomized assignment	An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups.
4	SEVCO:01006	simple randomization	A randomized assignment in which each participant has the same prespecified likelihood of being assigned to a group as all other participants, independent of the assignment of any other participant.
4	SEVCO:01007	stratified randomization	A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups
4	SEVCO:01008	block randomization	A randomized assignment in which a pre-specified number of subjects is assigned to a block containing the same pre-specified ratio of group assignments in random order.
4	SEVCO:01009	adaptive randomization	A randomized assignment in which a participant’s group assignment probability is adjusted based on any factor such that the likelihood of assignment is not the same for all participants.
3	SEVCO:01005	Non-randomized assignment	An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by methods other than random chance to separate groups.
4	SEVCO:01004	Quasi-Randomized assignment	An interventional study design with a method of allocation that is not limited to random chance but is intended to produce similar baseline groups for experimentation.
3	SEVCO:01029	Clinical trial	Interventional research in which one or more healthcare-related actions (i.e., a diagnostic, prognostic, therapeutic, preventive or screening method or intervention) is evaluated for effects on health-related biomedical or behavioral processes and/or outcomes.
4	SEVCO:01041	Pragmatic clinical trial	A clinical trial conducted under conditions of routine clinical practice.
4	SEVCO:01038	Expanded Access study	A clinical trial that provides a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study.
4	SEVCO:01030	Phase 1 trial	A clinical trial to gather initial evidence in humans to support further investigation of an intervention.
5	SEVCO:01031	Exploratory investigational new drug study	A clinical trial that is conducted early in phase 1, involves very limited human exposure, and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies).
4	SEVCO:01032	Phase 1/Phase 2 trial	A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial.
4	SEVCO:01033	Phase 2 trial	A clinical trial to gather evidence of effectiveness and safety for an intervention in patients with the disease or condition under study, but not intended to provide an adequate basis for regulatory approval for clinical use.
4	SEVCO:01034	Phase 2/Phase 3 trial	A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial.
4	SEVCO:01035	Phase 3 Trial	A clinical trial to gather the evidence of effectiveness and safety of an intervention, intended to provide an adequate basis for regulatory approval for clinical use.
4	SEVCO:01036	Post-marketing study	A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.
2	SEVCO:01002	Observational research	A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.
3	SEVCO:01037	Post-Marketing Surveillance study	An observational study to identify adverse events related to the use of an approved clinical intervention.
2	SEVCO:01010	Comparative study design	A study design in which two or more groups are compared.
3	SEVCO:01011	Parallel cohort design	A comparative study design in which the groups are compared concurrently and participants are expected to remain in the groups being compared for the entire duration of participation in the study.
3	SEVCO:01012	Crossover cohort design	A comparative study design in which participants receive two or more alternative exposures during separate periods of time.
4	SEVCO:01024	Controlled crossover cohort design	A crossover cohort design in which two or more cohorts have different orders of exposures.
4	SEVCO:01025	Single-arm crossover design	A crossover cohort design in which all participants are in a single cohort with the same order of exposures.
3	SEVCO:01013	Case control design	A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).
3	SEVCO:01014	Matching for comparison	A comparative study design in which individual participants in different groups being compared are paired or matched into sets based on selected attributes for within-set analysis.
4	SEVCO:01020	Family study design	A matched study design in which related or non-related family members are compared.
5	SEVCO:01021	Twin study design	A family study design in which twin siblings are compared.
3	SEVCO:01015	Cluster as unit of allocation	A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.
2	SEVCO:01023	Non-comparative study design	A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.
3	SEVCO:01016	Uncontrolled cohort design	A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).
3	SEVCO:01017	Case report	A non-comparative study design in which a single participant is evaluated.
2	SEVCO:01022	Population-based design	A study design in which the unit of observation is a population or community.
3	SEVCO:01044	Ecological design	A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.
2	SEVCO:01027	Cross sectional data collection	A study design process in which data is collected at a single point in time.
2	SEVCO:01028	Longitudinal data collection	A study design process in which data is collected at two or more points in time.
3	SEVCO:01018	Time series design	A longitudinal data collection which includes a set of time-ordered observations.
4	SEVCO:01019	Before and after comparison	A time series design which includes comparisons of observations before and after an event or exposure.
2	SEVCO:01045	Primary data collection	A study design process in which the data are recorded and collected during the study for the purpose of the same study.
2	SEVCO:01026	Real world data collection	A study design process in which the study data are obtained from a source of data collected during a routine process in the natural environment rather than using a process designed or controlled by the researcher.
3	SEVCO:01039	Real world data collection from healthcare records	Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.
3	SEVCO:01050	Real world data collection from personal health records	Real world data collection from data obtained routinely for a purpose of recording data related to personal health in a record controlled by the person, guardian, or caretaker.
3	SEVCO:01040	Real world data collection from healthcare financing records	Real world data collection from data obtained routinely for a purpose of recording healthcare financing.
3	SEVCO:01048	Real world data collection from testing procedures	Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination.
4	SEVCO:01046	Real world data collection from monitoring procedures	Real world data collection from data obtained routinely for a purpose of repeated testing.
2	SEVCO:01049	Secondary data collection from prior research	A study design process in which the data are collected from data obtained during a different study than the current study.
2	SEVCO:01042	Secondary data collection from a registry	A study design process in which the data are collected from a system organized to obtain and maintain uniform data for discovery and analysis, and this system is organized prior to the current study.
2	SEVCO:01051	Multisite data collection	A study design process in which data are collected from two or more geographic locations.
2	SEVCO:01086	Quantitative analysis	A study design process in which data are analyzed with mathematical or statistical methods and formulas.
2	SEVCO:01087	Qualitative analysis	A study design process in which data are analyzed, without primary reliance on mathematical or statistical techniques, by coding and organizing data to provide interpretation or understanding of experiences or hypotheses.
2	SEVCO:01060	Blinding of study participants	A study design process in which study participants are not informed of their intervention assignment.
2	SEVCO:01061	Blinding of intervention providers	A study design process in which the people administering the intervention are not informed of the intervention assignment.
2	SEVCO:01062	Blinding of outcome assessors	A study design process in which the people determining the outcome are not informed of the intervention assignment.
2	SEVCO:01063	Blinding of data analysts	A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.
2	SEVCO:01064	Allocation concealment	A study design process in which all parties influencing study enrollment and allocation to study groups are unaware of the group assignment for the study participant at the time of enrollment and allocation.
2	SEVCO:01043	Multicentric	A study design feature in which two or more institutions are responsible for the conduct of the study.
2	SEVCO:01052	Includes patient-reported outcome	A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.
2	SEVCO:01053	Includes patient-centered outcome	A study design feature in which one or more measures are outcomes that patients directly care about, i.e. outcomes that are directly related to patients' experience of their life.
2	SEVCO:01054	Includes disease-oriented outcome	A study design feature in which one or more measures are outcomes that relate to a health or illness condition but are not outcomes which patients directly care about.
2	SEVCO:01085	Includes process measure	A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.
2	SEVCO:01089	Study Goal	A study design feature specifying the intent of the study.
3	SEVCO:01096	Evaluation Goal	A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.
3	SEVCO:01097	Derivation Goal	A study goal with the intent to generate a predictive algorithm.
3	SEVCO:01098	Validation Goal	A study goal with the intent to determine the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose.
3	SEVCO:01088	Comparison Goal	A study design feature in which the study intent is to compare two or more interventions or exposures.
4	SEVCO:01091	Comparative Effectiveness Goal	A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.
5	SEVCO:01090	Comparative Efficacy Goal	A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.
5	SEVCO:01092	Comparative Safety Goal	A study design feature in which the study intent is to compare two or more interventions with respect to harms.
4	SEVCO:01093	Equivalence Goal	A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is within a prespecified range representing absence of a meaningful difference.
4	SEVCO:01094	Non-inferiority Goal	A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is below a prespecified value representing a threshold between a meaningful difference and absence of a meaningful difference.
4	SEVCO:01095	Superiority Goal	A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.

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