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

CodeSystem: Research Study Document Types Code System

Official URL: http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system Version: 1.0.0-ballot2
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudyDocumentTypesCodeSystem
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.16.5

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

This Code system is referenced in the content logical definition of the following value sets:

This case-sensitive code system http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system defines the following codes:

CodeDisplayDefinition
adverse-event-monitoring-plan Adverse event monitoring plan The detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed.
ancillary-care-plan Ancillary care plan The detailed protocol for treatment and supportive care activities provided during and after the study.
auditing-plan Auditing plan The detailed protocol for how research study integrity will be evaluated, monitored, and managed.
confidential-personal-data-management-plan Confidential personal data management plan The 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-form Consent form The document used to obtain and record consent or assent.
consent-plan Consent plan The detailed protocol for how consent or assent will be obtained.
data-access-plan Data access plan The detailed protocol for how all of some of the research study dataset will be made available.
data-management-plan Data management plan The detailed protocol for how data from a study will be collected, preserved, and shared.
dataset Dataset The collection of data generated by the research study.
dataset-access Dataset access The information related to how to access the dataset.
declaration-of-interests Declaration of interests The statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting.
dissemination-plan Dissemination plan The detailed protocol for how research study results will be reported and advertised.
education Education Instructional and orientational information.
interim-analysis-plan Interim analysis plan The detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection.
irb-approval Institutional Review Board (IRB) approval The document that proposed or establishes Institutional Review Board (IRB) approval.
software Software The executable tools used to support the conduct and reporting of the research study.
software-access Software access The information related to how to access the research software.
specimen-plan Specimen plan The detailed protocol for how specimens collected during the study will be managed.
statistical-analysis-plan Statistical analysis plan The detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study.