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See the Directory of published versions 
| Clinical Decision Support  Work Group | Maturity Level: 1 | Trial Use | Use Context: Country: World | 
| Official URL: http://hl7.org/fhir/ValueSet/study-design | Version: 6.0.0-ballot3 | |||
| draft as of 2022-08-24 | Computable Name: StudyDesign | |||
| Flags: Immutable | OID: 2.16.840.1.113883.4.642.3.3045 | |||
This value set is used in the following places:
This is a set of terms for study design characteristics.
Generated Narrative: ValueSet study-design
Last updated: 2025-10-23T19:40:00Z
Profile: Shareable ValueSet
http://hl7.org/fhir/study-design version 📦6.0.0-ballot3
This expansion generated 23 Oct 2025
ValueSet
Expansion performed internally based on codesystem Study Design v6.0.0-ballot3 (CodeSystem)
This value set contains 72 concepts
| Level | System | Code | Display | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01001 | Interventional research | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01003 | randomized assignment | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01006 | simple randomization | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01007 | stratified randomization | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01008 | block randomization | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01009 | adaptive randomization | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01005 | Non-randomized assignment | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01004 | Quasi-Randomized assignment | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01029 | Clinical trial | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01041 | Pragmatic clinical trial | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01038 | Expanded Access study | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01030 | Phase 1 trial | 
| 4 | http://hl7.org/fhir/study-design | SEVCO:01031 | Exploratory investigational new drug study | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01032 | Phase 1/Phase 2 trial | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01033 | Phase 2 trial | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01034 | Phase 2/Phase 3 trial | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01035 | Phase 3 trial | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01036 | Post-marketing study | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01002 | Observational research | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01037 | Post-Marketing Surveillance study | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01010 | Comparative study design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01011 | Parallel cohort design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01012 | Crossover cohort design | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01024 | Controlled crossover cohort design | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01025 | Single-arm crossover design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01013 | Case control design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01014 | Matching for comparison | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01020 | Family study design | 
| 4 | http://hl7.org/fhir/study-design | SEVCO:01021 | Twin study design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01015 | Cluster as unit of allocation | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01023 | Non-comparative study design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01016 | Uncontrolled cohort design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01017 | Case report | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01022 | Population-based design | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01044 | Ecological design | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01027 | Cross sectional data collection | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01028 | Longitudinal data collection | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01018 | Time series design | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01019 | Before and after comparison | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01045 | Primary data collection | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01026 | Real world data collection | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01039 | Real world data collection from healthcare records | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01050 | Real world data collection from personal health records | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01040 | Real world data collection from healthcare financing records | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01048 | Real world data collection from testing procedures | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01046 | Real world data collection from monitoring procedures | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01049 | Secondary data collection from prior research | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01042 | Secondary data collection from a registry | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01051 | Multisite data collection | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01086 | Quantitative analysis | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01087 | Qualitative analysis | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01060 | Blinding of study participants | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01061 | Blinding of intervention providers | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01062 | Blinding of outcome assessors | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01063 | Blinding of data analysts | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01064 | Allocation concealment | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01043 | Multicentric | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01052 | Includes patient-reported outcome | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01053 | Includes patient-centered outcome | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01054 | Includes disease-oriented outcome | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01085 | Includes process measure | 
| 1 | http://hl7.org/fhir/study-design | SEVCO:01089 | Study Goal | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01096 | Evaluation Goal | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01097 | Derivation Goal | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01098 | Validation Goal | 
| 2 | http://hl7.org/fhir/study-design | SEVCO:01088 | Comparison Goal | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01091 | Comparative Effectiveness Goal | 
| 4 | http://hl7.org/fhir/study-design | SEVCO:01090 | Comparative Efficacy Goal | 
| 4 | http://hl7.org/fhir/study-design | SEVCO:01092 | Comparative Safety Goal | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01093 | Equivalence Goal | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01094 | Non-inferiority Goal | 
| 3 | http://hl7.org/fhir/study-design | SEVCO:01095 | Superiority Goal | 
See the full registry of value sets defined as part of FHIR.
Explanation of the columns that may appear on this page:
| Lvl | A few code lists that FHIR defines are hierarchical - each code is assigned a level. For value sets, levels are mostly used to organize codes for user convenience, but may follow code system hierarchy - see Code System for further information | 
| Source | The source of the definition of the code (when the value set draws in codes defined elsewhere) | 
| Code | The code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract') | 
| Display | The 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 | 
| Definition | An explanation of the meaning of the concept | 
| Comments | Additional notes about how to use the code |