Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | cmc-ectd-document-32s23 |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/cmc-ectd-document-32s23 |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | CMCeCTDDocument32S23 |
title | CMC eCTD 32S23 Document |
date | 2023-07-17T03:00:13+00:00 |
description | Definition for a document bundle with the CMC eCTD 32S23 profiles. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | Bundle |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/Bundle |
Usages | (none) |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Bundle | C | Bundle |
CMC eCTD 32S23 Bundle cmc-first-resource: A document must have a Composition as the first resource cmc-identifer: A document must have an identifier with a system and a value |
|
meta | ||||
versionId | S | 1.. | ||
identifier | S | 1.. | ||
type | S |
document Fixed Value: document |
||
timestamp | S | 1.. | ||
Slices for entry | S | 4 .. | Slice: Unordered, Open by profile:resource | |
entry:Composition | 1..1 | |||
fullUrl | S | |||
resource | S | Composition | ||
entry:SubstanceDefinition | 1..* | |||
fullUrl | S | |||
resource | S | SubstanceDefinition | ||
entry:Organization | 1..1 | |||
fullUrl | 1.. | |||
resource | 1.. | Organization | ||
entry:OrganizationMfg | 1..* | |||
fullUrl | 1.. | |||
resource | 1.. | Organization | ||
entry:PlanDefinition | 0..* | |||
fullUrl | S | |||
resource | S | PlanDefinition | ||
Documentation for this format |
Produced 08 Sep 2023