Clinical Study Schedule of Activities
1.0.0 - trial-use

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## Profiles

# SoA Resource Profiles

The following profiles are defined for exchanging study schedule information.

Resource | Profile Name | Profile Description
--- | --- | ---
ResearchStudy | ResearchStudySoa | A profile that lists the data elements of a Research Study that must be supported when used to schedule activities.
PlanDefinition | StudyProtocolSoa | A profile that lists the data elements of a PlanDefinition that must be supported so that it can represent an entire set of visits and activities for a given study protocol.
PlanDefinition | StudyVisitSoa | An abstract profile that lists the data elements of a PlanDefinition that must be supported so that it can represent a Study Visit.
PlanDefinition | PlannedStudyVisitSoa | A profile that further qualifies the StudyVisitSoa profile so that it can represent a planned visit.
ActivityDefinition | StudyActivitySoa | A profile lists the data elements of an ActivityDefinition that must be supported so that it can represent an activity that is being scheduled.

### Extensions

The following extensions are defined to enable data elements that are not currently present in the core resources.

Extension | Context | Description
--- | --- | ---
AcceptableOffsetRange | PlanDefinition.action.relatedAction | Provides an offset range that, along with offsetDuration, indicates an acceptable range of dates for a related action, i.e. +10-15 days

### Global Profiles

There are no Global profiles defined

### IG Dependencies

This IG Contains the following dependencies on other IGs.

IG | Package | FHIR | Comment
--- | --- | --- | ---
Clinical Study Schedule of Activities | hl7.fhir.uv.vulcan-schedule#1.0.0 | R4 |
HL7 Terminology (THO) | hl7.terminology.r4#5.0.0 | R4 | Automatically added as a dependency - all IGs depend on HL7 Terminology

### Cross-Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.uv.vulcan-schedule.r4) and R4B (hl7.fhir.uv.vulcan-schedule.r4b) are available.

### Intellectual Property Statements

This publication includes IP covered under the following statements.

- Copyright HL7. Licensed under creative commons public domain
  Show Usage
  - identifierType: PlanDefinition/H2Q-MC-LZZT-ProtocolDesign, PlanDefinition/H2Q-MC-LZZT-Study-Visit-1, PlanDefinition/H2Q-MC-LZZT-Study-Visit-3 and Practitioner/SamGetWell
- The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
  Show Usage
  - Unified Code for Units of Measure (UCUM): PlanDefinition/H2Q-MC-LZZT-ProtocolDesign
- This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact http://www.snomed.org/snomed-ct/get-snomed-ct or info@snomed.org.
  Show Usage
  - SNOMED Clinical Terms® (SNOMED CT®): ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Temperature and ResearchStudy/H2Q-MC-LZZT-ResearchStudy