Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-drug-substance-container-closure |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-drug-substance-container-closure |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | SubstanceContainerClosure |
title | Drug Substance Container Closure |
date | 2023-07-17T03:00:13+00:00 |
description | Description and coding of the container closure system. Profile on Drug Substance profile. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | SubstanceDefinition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/SubstanceDefinition |
Usages |
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Name | Flags | Card. | Type |
Description & Constraints
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C | SubstanceDefinition | cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acid','Polymer','Protein - Other'. | |
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S | ..1 | ||
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1.. | Slice: Unordered, Open by value:url | ||
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S | 1..1 | (Complex) |
Container Closure System Information
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-container-closure-extension |
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S | ..1 | optional user designated identifier | |
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S | 1..1 | Reference (Manufacturing and/or Test Site Organization) | |
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S | |||
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Slice: Unordered, Open by pattern:system | |||
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0..1 | UNII | ||
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1.. | Required Pattern: https://gsrs.ncats.nih.gov | ||
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0..1 | UniProt ID | ||
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1.. | Required Pattern: https://www.uniprot.org | ||
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S C | 1 .. |
Only one name required
Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
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Content/Rules for all slices | |||
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S | True when the name type is Substance Name | ||
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S | 0..1 | ||
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S | Generic | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 138 |
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1..1 | string |
Representation defined by the system Fixed Value: Generic |
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S | |||
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S | 0..1 | ||
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S | Common | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 139 |
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1..1 | string |
Representation defined by the system Fixed Value: Common |
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S | |||
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S | 0..1 | ||
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S | GSRS Preferred | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 141 |
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1..1 | string |
Representation defined by the system Fixed Value: GSRS Preferred |
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S | |||
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S | 0..1 | ||
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S | ISBT 128 | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 226 |
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1..1 | string |
Representation defined by the system Fixed Value: ISBT 128 |
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S | |||
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Produced 08 Sep 2023