StructureDefinition-m11-section-06

Sourcehl7.fhir.uv.ebm#current:null (v5.0.0)
resourceTypeStructureDefinition
idm11-section-06
canonicalhttps://hl7.org/fhir/uv/ebm/StructureDefinition/m11-section-06
version0.1.0
statusdraft
publisherHL7 International - Clinical Decision Support WG
nameM11Section06
date2023-08-31T13:08:31+00:00
descriptionProfile of Composition for Evidence Based Medicine IG. The M11Section06 Profile is used for summary of Section 6 Trial Intervention and Concomitant Therapy 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:section06 S 1..1
. . . . . text 1.. Required Pattern: Section 6 Trial Intervention and Concomitant Therapy
. . . Slices for section 8 .. Slice: Unordered, Open by pattern:code
. . . . section:description S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.1 Description of Trial Intervention
. . . . . text 1..
. . . . . entry Reference (InterventionDefinition)
. . . . section:rationale S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.2 Rationale for Trial Intervention
. . . . . text 1..
. . . . . entry Reference (InterventionDefinition)
. . . . section:dosingAdministration S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.3 Dosing and Administration
. . . . . text 1..
. . . . . entry Reference ( ActivityDefinition )
. . . . . Slices for section Slice: Unordered, Open by pattern:code
. . . . . . section:doseModification S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 6.3.1 Trial Intervention Dose Modification
. . . . . . . text 1..
. . . . . . . entry Reference ( ActivityDefinition )
. . . . section:treatmentOfOverdose S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.4 Treatment of Overdose
. . . . . text 1..
. . . . . entry Reference ( ActivityDefinition )
. . . . section:preparation S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.5 Preparation, Handling, Storage and Accountability
. . . . . text 1..
. . . . section:assignmentAndBlinding S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.6 Participant Assignment, Randomisation and Blinding
. . . . . text 1..
. . . . section:compliance S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.7 Trial Intervention Compliance
. . . . . text 1..
. . . . section:concomitantTherapy S 1..1
. . . . . code
. . . . . . text Required Pattern: 6.8 Concomitant Therapy
. . . . . text 1..

doco Documentation for this format

Produced 08 Sep 2023