Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - 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-ballot2 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-ballot2
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudyDocumentTypes
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.10

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-ballot2 (CodeSystem)

This value set contains 19 concepts

CodeSystemDisplayDefinition
  adverse-event-monitoring-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemAdverse event monitoring planThe detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed.
  ancillary-care-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemAncillary care planThe detailed protocol for treatment and supportive care activities provided during and after the study.
  auditing-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemAuditing planThe detailed protocol for how research study integrity will be evaluated, monitored, and managed.
  confidential-personal-data-management-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemConfidential 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.
  consent-formhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemConsent formThe document used to obtain and record consent or assent.
  consent-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemConsent planThe detailed protocol for how consent or assent will be obtained.
  data-access-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemData access planThe detailed protocol for how all of some of the research study dataset will be made available.
  data-management-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemData management planThe detailed protocol for how data from a study will be collected, preserved, and shared.
  datasethttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemDatasetThe collection of data generated by the research study.
  dataset-accesshttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemDataset accessThe information related to how to access the dataset.
  declaration-of-interestshttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemDeclaration of interestsThe statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting.
  dissemination-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemDissemination planThe detailed protocol for how research study results will be reported and advertised.
  educationhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemEducationInstructional and orientational information.
  interim-analysis-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemInterim analysis planThe detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection.
  irb-approvalhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemInstitutional Review Board (IRB) approvalThe document that proposed or establishes Institutional Review Board (IRB) approval.
  softwarehttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemSoftwareThe executable tools used to support the conduct and reporting of the research study.
  software-accesshttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemSoftware accessThe information related to how to access the research software.
  specimen-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemSpecimen planThe detailed protocol for how specimens collected during the study will be managed.
  statistical-analysis-planhttp://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-systemStatistical analysis planThe detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study.

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System 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)
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