StructureDefinition-m11-section-10

Sourcehl7.fhir.uv.ebm#current:null (v5.0.0)
resourceTypeStructureDefinition
idm11-section-10
canonicalhttps://hl7.org/fhir/uv/ebm/StructureDefinition/m11-section-10
version0.1.0
statusdraft
publisherHL7 International - Clinical Decision Support WG
nameM11Section10
date2023-08-31T13:08:31+00:00
descriptionProfile of Composition for Evidence Based Medicine IG. The M11Section10 Profile is used for summary of Section 10 General Considerations: Regulatory, Ethical, and Trial Oversight for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.
jurisdictionsuv
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeComposition
derivationconstraint
basehttps://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-report
Usages(none)
Name Flags Card. Type Description & Constraints doco
. . Composition EvidenceReport
. . . Slices for category 1 .. Slice: Unordered, Open by pattern:text
. . . . category:section10 S 1..1
. . . . . text 1.. Required Pattern: Section 10 General Considerations: Regulatory, Ethical, and Trial Oversight
. . . Slices for section 5 .. Slice: Unordered, Open by pattern:code
. . . . section:regulatory S 1..1
. . . . . code
. . . . . . text Required Pattern: 10.1 Regulatory and Ethical Considerations
. . . . . text 1..
. . . . section:committees S 1..1
. . . . . code
. . . . . . text Required Pattern: 10.2 Committees
. . . . . text 1..
. . . . section:informedConsent S 1..1
. . . . . code
. . . . . . text Required Pattern: 10.3 Informed Consent Process
. . . . . text 1..
. . . . section:dataProtection S 1..1
. . . . . code
. . . . . . text Required Pattern: 10.4 Data Protection
. . . . . text 1..
. . . . section:earlyTermination S 1..1
. . . . . code
. . . . . . text Required Pattern: 10.5 Early Site Closure or Trial Termination
. . . . . text 1..

doco Documentation for this format

Produced 08 Sep 2023