Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-stability-summary |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-stability-summary |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | StabilitySummary |
title | Stability Summary |
date | 2023-07-17T03:00:13+00:00 |
description | Summary of the types of studies conducted (forced degradation, photostability, and stress testing), protocols used, and the results of the studies |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | PlanDefinition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/PlanDefinition |
Usages |
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Name | Flags | Card. | Type |
Description & Constraints
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PlanDefinition | |||
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S | ..1 | ||
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Slice: Unordered, Open by value:url | |||
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S | 0..* | markdown |
Study Summary Additional URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension |
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S | 1..1 | ||
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S | |||
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S | 1..1 | ||
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S | Quantity | Expiry Period | Retest Period | |
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S | 1.. | ||
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S | 1.. | Expiry Period UOM | Retest Period UOM | |
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S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
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S | 1..1 | Expiry or Retest per storage condidtion | |
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S | |||
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Storage Condition for Expiry Period| Storage Condition for Retest Period Binding: Storage Conditions Terminology ( required ) |
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S | |||
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Required Pattern: documentation | |||
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S | 1.. | Refernce to Study Name | |
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S | 1.. | Period details | |
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Produced 08 Sep 2023