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 |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
PlanDefinition | PlanDefinition | |||
meta | ||||
profile | S | ..1 | ||
Slices for extension | Slice: Unordered, Open by value:url | |||
studysum-additional-info | S | 0..* | markdown |
Study Summary Additional URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension |
identifier | S | 1..1 | ||
status | S | |||
goal | ||||
target | S | 1..1 | ||
detail[x] | S | Quantity | Expiry Period | Retest Period | |
value | S | 1.. | ||
unit | S | 1.. | Expiry Period UOM | Retest Period UOM | |
code | S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
action | S | 1..1 | Expiry or Retest per storage condidtion | |
code | S | |||
coding | ||||
code |
Storage Condition for Expiry Period| Storage Condition for Retest Period Binding: Storage Conditions Terminology ( required ) |
|||
documentation | S | |||
type | Required Pattern: documentation | |||
document | ||||
title | S | 1.. | Refernce to Study Name | |
goalId | S | 1.. | Period details | |
Documentation for this format |
Produced 08 Sep 2023