Source | hl7.fhir.uv.ebm#current:null (v5.0.0) |
resourceType | StructureDefinition |
id | m11-section-12 |
canonical | https://hl7.org/fhir/uv/ebm/StructureDefinition/m11-section-12 |
version | 0.1.0 |
status | draft |
publisher | HL7 International - Clinical Decision Support WG |
name | M11Section12 |
date | 2023-08-31T13:08:31+00:00 |
description | Profile of Composition for Evidence Based Medicine IG. The M11Section12 Profile is used for summary of Section 12 Appendix: Adverse Events and Serious Adverse Events -- Definitions, Severity, and Causality for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification. |
jurisdictions | uv |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | Composition |
derivation | constraint |
base | https://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-report |
Usages | (none) |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | EvidenceReport | |||
Slices for category | 1 .. | Slice: Unordered, Open by pattern:text | ||
category:section12 | S | 1..1 | ||
text | 1.. | Required Pattern: Section 12 Appendix: Adverse Events and Serious Adverse Events -- Definitions, Severity, and Causality | ||
Slices for section | 4 .. | Slice: Unordered, Open by pattern:code | ||
section:adverseEventsDefinition | S | 1..1 | ||
code | ||||
text | Required Pattern: 12.1 Further Details and Clarifications on the AE Definition | |||
text | 1.. | |||
section:seriousAdverseEventsDefinition | S | 1..1 | ||
code | ||||
text | Required Pattern: 12.2 Further Details and Clarifications on the SAE Definition | |||
text | 1.. | |||
section:severity | S | 1..1 | ||
code | ||||
text | Required Pattern: 12.3 Severity | |||
text | 1.. | |||
section:causality | S | 1..1 | ||
code | ||||
text | Required Pattern: 12.4 Causality | |||
text | 1.. | |||
Documentation for this format |
Produced 08 Sep 2023