Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

ValueSet: Research Study Document Types Value Set

Official URL: http://hl7.org/fhir/uv/ebm/ValueSet/research-study-document-types Version: 1.0.0-ballot3
Standards status: Trial-use Active as of 2025-12-18 Maturity Level: 1 Computable Name: ResearchStudyDocumentTypes
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.12

Codes for use in the DocumentReference.type element when referenced from ResearchStudy.relatesTo.targetReference.

References

Logical Definition (CLD)

 

Expansion

Expansion performed internally based on codesystem Research Study Document Types Code System v1.0.0-ballot3 (CodeSystem)

This value set contains 19 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  adverse-event-monitoring-planAdverse event monitoring planThe detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  ancillary-care-planAncillary care planThe detailed protocol for treatment and supportive care activities provided during and after the study.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  auditing-planAuditing planThe detailed protocol for how research study integrity will be evaluated, monitored, and managed.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  confidential-personal-data-management-planConfidential personal data management planThe detailed protocol for how personally identifiable data from a research study will be shared and preserved, and how such data will be protected from inappropriate sharing.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  consent-formConsent formThe document used to obtain and record consent or assent.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  consent-planConsent planThe detailed protocol for how consent or assent will be obtained.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  data-access-planData access planThe detailed protocol for how all of some of the research study dataset will be made available.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  data-management-planData management planThe detailed protocol for how data from a study will be collected, preserved, and shared.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  datasetDatasetThe collection of data generated by the research study.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  dataset-accessDataset accessThe information related to how to access the dataset.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  declaration-of-interestsDeclaration of interestsThe statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  dissemination-planDissemination planThe detailed protocol for how research study results will be reported and advertised.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  educationEducationInstructional and orientational information.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  interim-analysis-planInterim analysis planThe detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  irb-approvalInstitutional Review Board (IRB) approvalThe document that proposed or establishes Institutional Review Board (IRB) approval.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  softwareSoftwareThe executable tools used to support the conduct and reporting of the research study.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  software-accessSoftware accessThe information related to how to access the research software.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  specimen-planSpecimen planThe detailed protocol for how specimens collected during the study will be managed.
http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system  statistical-analysis-planStatistical analysis planThe detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study.

Description of the above table(s).