Source | hl7.fhir.us.spl#current:SPL Mapping FHIR Implementation Guide (v4.3.0) |
resourceType | StructureDefinition |
id | ProductSubmissionDocument |
canonical | http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument |
version | 0.1.0 |
status | draft |
publisher | Biomedical Research and Regulatory WG |
name | ProductSubmissionDocument |
date | 2023-07-20T15:25:38+00:00 |
description | A profile that represents a document that is required for Product Submission to the FDA. |
jurisdictions | us |
fhirVersion | 4.3.0 |
kind | resource |
abstract | false |
sdTtype | Composition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/Composition |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | Composition | |||
Slices for extension | 1.. | Slice: Unordered, Open by value:url | ||
versionNumber | S | 1..1 | string |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/versionNumber |
identifier | S | 1.. | ||
type | S | Binding: SPL Document Codes ( required ) | ||
author | S | ..1 | Reference (IdentifiedLabeler) | |
title | S | |||
Slices for section | S | 1 .. | Slice: Unordered, Open by value:code | |
section:All Slices | Content/Rules for all slices | |||
Slices for extension | Slice: Unordered, Open by value:url | |||
sectionTime | S | 0..1 | dateTime, Period |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime |
linkId | S | 0..1 | string |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId |
title | S | |||
code | S | 1.. | Binding: SPL Section Codes ( required ) | |
text | S | |||
entry | S | |||
section | S | BackboneElement | ||
Slices for extension | Slice: Unordered, Open by value:url | |||
sectionTime | S | 0..1 | dateTime, Period |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime |
linkId | S | 0..1 | string |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId |
title | S | |||
code | S | 1.. | Binding: SPL Section Codes ( required ) | |
text | S | 1.. | ||
entry | .. 0 | |||
section:ProductSection | 0..1 | |||
sectionTime | S | 0..1 | dateTime, Period |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime |
linkId | S | 0..1 | string |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId |
title | .. 0 | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://loinc.org |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 48780-1 |
|
entry | 1.. | Reference (SubmittedMedicinalProduct) | ||
section | .. 0 | |||
section:LabelDisplay | 0..* | |||
sectionTime | S | 0..1 | dateTime, Period |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime |
linkId | S | 0..1 | string |
Extension
URL: http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId |
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://loinc.org |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 51945-4 |
|
text | 1.. | |||
entry | .. 0 | |||
section | .. 0 | |||
Documentation for this format |
Produced 08 Sep 2023