IP Review

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This publication includes IP covered under the following statements.

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 https://www.snomed.org/get-snomed or info@snomed.org .
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- SNOMED Clinical Terms® (SNOMED CT®): ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Temperature and ResearchStudy/H2Q-MC-LZZT-ResearchStudy
This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
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IG © 2022+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.vulcan-schedule#2.0.0-ballot based on FHIR 6.0.0-ballot3. Generated 2026-03-31 Links: Table of Contents | QA Report | Version History | CC0 | Propose a change ( src )

hl7.fhir.us.hai: Healthcare Associated Infection Implementation Guide ®© HL7 | CC0 ( src )

28-Day Cycle (e.g., Lonsurf®) * Treatment Period: The drug Trifluridine-tipiracil hydrochloride is taken as a tablet twice a day. * Rest Period: A 28-day period encompasses the full cycle of treatment. ( src )

Clinical Study Schedule of Activities, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions ( src )

Protocol H2Q-MC-LZZT(c) ( src )

The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element. ( src )

The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element. ( src )

This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html Show Usage * Contact entity type: Organization/EliLillyAndCompany * Organization type: Organization/EliLillyAndCompany * PlanDefinitionType: Levothroxine-Monitoring-Schedule, Levothroxine-Monitoring-Titration-Activities... Show 6 more, PlanDefinition/H2Q-MC-LZZT-ProtocolDesign, PlanDefinition/H2Q-MC-LZZT-Study-Visit-1, PlanDefinition/H2Q-MC-LZZT-Study-Visit-3, dynamic-visit-schedule-exit-example-PlanDefinition, dynamic-visit-schedule-multiple-paths and dynamic-visit-schedules-cycles-scheduled-interactions * ResearchStudyObjectiveType: ResearchStudy/H2Q-MC-LZZT-ResearchStudy * ResearchStudyPhase: ResearchStudy/H2Q-MC-LZZT-ResearchStudy * ResearchStudyPrimaryPurposeType: ResearchStudy/H2Q-MC-LZZT-ResearchStudy * identifierType: PlanDefinition/H2Q-MC-LZZT-ProtocolDesign, PlanDefinition/H2Q-MC-LZZT-Study-Visit-1, PlanDefinition/H2Q-MC-LZZT-Study-Visit-3 and Practitioner/SamGetWell ( src )

External References

Type	Reference	Content
web	browser.ihtsdotools.org	http://snomed.info/sct
web	www.lilly.com	https://www.lilly.com
web	github.com	Clinical Study Schedule of Activities, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions
web	www.cdisc.org	The CDISC ODM is a model designed for the transportation and storage of Study Data for Clinical Studies. The landing page for the standard can be found here: https://www.cdisc.org/standards/data-exchange/odm
web	cdisc.org	Note: the CDISC ODM is owned by CDISC . A free CDISC website account is required to access the material - create an account here .
web	www.cdisc.org	Note: the CDISC ODM is owned by CDISC . A free CDISC website account is required to access the material - create an account here .
web	github.com	The CDISC repository for the ODM found here .
web	github.com	ODM Schema
web	www.sciencedirect.com	For an example of a master protocol , the existing `ResearchStudy.partOf` predicate can be used for the sub-studies as part of master protocol, this allows for differentiation of eligibility criteria, lifecycle, etc.
web	medinform.jmir.org	We have chosen to use the extensions proposed by Richardson A, Genyn P Clinical Trial Schedule of Activities Specification Using Fast Healthcare Interoperability Resources Definitional Resources: Mixed Methods Study JMIR Med Inform 2025;13:e71430 - henceforth referred to as MMS. The authors have kindly agreed for their work to be utilised as part of the IG, with the qualification that full recognition for the work shall remain theirs alone.
web	www.cdisc.org	Using the extensions we can represent the SoA as a Graph - this is key to being able to provide decision support in a prospective manner for a user utilising a healthcare system to manage the execution of a clinical trial. There are analogues to the implementation of Timelines in the CDISC Unified Study Design Model (USDM) ; so transformations between representations of Study Designs should be mappable between the standards.
web	en.wikipedia.org	This drive for efficiency has given rise to adaptive designs and master protocols, such as platform , basket , and umbrella trials. These modern approaches often incorporate conditional logic, where the study path for a participant can change based on interim results, biomarker status, or other criteria. Consequently, the schedule of activities is no longer a static table but a dynamic plan with branching pathways and conditional events. While these designs can accelerate drug development and reduce overall costs, they introduce significant complexity in defining, implementing, and managing the schedule of activities across different systems. Additionally, under the guise of Adaptive Trial Design the implementation of the study can change significantly for a patient.
web	bmcmedicine.biomedcentral.com	This drive for efficiency has given rise to adaptive designs and master protocols, such as platform , basket , and umbrella trials. These modern approaches often incorporate conditional logic, where the study path for a participant can change based on interim results, biomarker status, or other criteria. Consequently, the schedule of activities is no longer a static table but a dynamic plan with branching pathways and conditional events. While these designs can accelerate drug development and reduce overall costs, they introduce significant complexity in defining, implementing, and managing the schedule of activities across different systems. Additionally, under the guise of Adaptive Trial Design the implementation of the study can change significantly for a patient.
web	database.ich.org	https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf ↩
web	database.ich.org	CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL - M11 ↩

Type

Reference

Content

web

browser.ihtsdotools.org

http://snomed.info/sct

web

www.lilly.com

https://www.lilly.com

web

github.com

web

www.cdisc.org

The CDISC ODM is a model designed for the transportation and storage of Study Data for Clinical Studies. The landing page for the standard can be found here: https://www.cdisc.org/standards/data-exchange/odm

web

cdisc.org

Note: the CDISC ODM is owned by CDISC . A free CDISC website account is required to access the material - create an account here .

web

www.cdisc.org

Note: the CDISC ODM is owned by CDISC . A free CDISC website account is required to access the material - create an account here .

web

github.com

The CDISC repository for the ODM found here .

web

github.com

ODM Schema

web

www.sciencedirect.com

For an example of a master protocol , the existing ResearchStudy.partOf predicate can be used for the sub-studies as part of master protocol, this allows for differentiation of eligibility criteria, lifecycle, etc.

web

medinform.jmir.org

We have chosen to use the extensions proposed by Richardson A, Genyn P Clinical Trial Schedule of Activities Specification Using Fast Healthcare Interoperability Resources Definitional Resources: Mixed Methods Study JMIR Med Inform 2025;13:e71430 - henceforth referred to as MMS. The authors have kindly agreed for their work to be utilised as part of the IG, with the qualification that full recognition for the work shall remain theirs alone.

web

www.cdisc.org

Using the extensions we can represent the SoA as a Graph - this is key to being able to provide decision support in a prospective manner for a user utilising a healthcare system to manage the execution of a clinical trial. There are analogues to the implementation of Timelines in the CDISC Unified Study Design Model (USDM) ; so transformations between representations of Study Designs should be mappable between the standards.

web

en.wikipedia.org

This drive for efficiency has given rise to adaptive designs and master protocols, such as platform , basket , and umbrella trials. These modern approaches often incorporate conditional logic, where the study path for a participant can change based on interim results, biomarker status, or other criteria. Consequently, the schedule of activities is no longer a static table but a dynamic plan with branching pathways and conditional events. While these designs can accelerate drug development and reduce overall costs, they introduce significant complexity in defining, implementing, and managing the schedule of activities across different systems. Additionally, under the guise of Adaptive Trial Design the implementation of the study can change significantly for a patient.

web

bmcmedicine.biomedcentral.com

web

database.ich.org

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf ↩

web

database.ich.org

CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL - M11 ↩

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