Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pq-stability-sub-study |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-stability-sub-study |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | StabilitySubStudy |
title | Stability Sub-Study |
date | 2023-07-17T03:00:13+00:00 |
description | Profile for the a stability sub-study. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | ResearchStudy |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/ResearchStudy |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ResearchStudy | ResearchStudy | |||
meta | ||||
profile | S | ..1 | ||
Slices for extension | Slice: Unordered, Open by value:url | |||
substudy-additional-info | S | 0..* | markdown |
Aditional Information
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension |
identifier | S | 1..1 | ||
version | S | Sub-Study Identifier Version (optional) | ||
title | S | 1.. | Sub-Study Name | |
partOf | Reference (Stability Study | Stability Sub-Study) | Reference to main study or associated study | ||
Slices for condition | S | 3 .. 3 | Slice: Unordered, Closed by value:coding.system | |
condition:substudytype | 1..1 |
Sub-Study Type Binding: Study Type Terminology ( required ) |
||
condition:storage | 1..1 |
Storage Conditions Temp.RH Binding: Storage Conditions Terminology ( required ) |
||
condition:storagecategory | 1..1 |
Storage Condition Category Binding: Storage Condition Category Terminology ( required ) |
||
condition:orientation | 0..1 |
Container Orientation Binding: Container Orientation Terminology ( required ) |
||
period | S | 1.. | ||
start | S | 1.. | Sub-study Start Date | |
end | S | Sub-Study End Date | ||
whyStopped | S | |||
coding | .. 0 | |||
text | S | 1.. | Reason Stopped | |
objective | ||||
description | S | 1.. | Study Purpose | |
result | Reference (Stability Study Interval Report) | Link to stability study results | ||
Documentation for this format |
Produced 08 Sep 2023