Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | ectd-composition-32s30 |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/ectd-composition-32s30 |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | EctdComposition32S30 |
title | eCTD Substance Characterization |
date | 2023-07-17T03:00:13+00:00 |
description | The fields needed to represent the Substance Structure and Impurities to be included under the 3.2.S.3.0 heading of the eCTD. References Sponsor Organization, Drug Substance Structure, and Drug Substance Impurities |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | Composition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/Composition |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | Composition | |||
meta | ||||
profile | S | ..1 | ||
identifier | S | ..1 | ||
status | Required Pattern: final | |||
type | 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://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 32S30 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Substance Characterization |
|
author | S | ..1 | Reference (Sponsor Organization) | |
title | S | |||
Slices for section | S | 1 .. | Slice: Unordered, Open by value:code | |
section:All Slices | Content/Rules for all slices | |||
entry | S | |||
section:Structure | S | 1..1 | ||
title | S | 1.. | ||
code | 1.. | 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://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 32S31 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Substance Elucidation of Structure and other Characteristics |
|
entry | 1..1 | Reference (Drug Substance) | ||
section:Impurities | S | 0..* | ||
Documentation for this format |
Produced 08 Sep 2023