Biomedical Research and Regulation
Biomedical Research Integrated Domain Group (Archived)Project Summary for Vulcan Schedule of Activities FHIR Implementation Guide (Jira PSS-2003)
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Project Details
Number | 1761 View Ballot Items List (with NIBs) |
---|---|
Name | Vulcan Schedule of Activities FHIR Implementation Guide (Jira PSS-2003) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | Clinical Decision Support Work Group |
Steering Division | N/A |
Description | This project intends to produce a set of FHIR Profiles that will allow for a schedule of activities of a clinical study to be represented as FHIR resources. The initial phase of the project will restrict itself to the initial definition of the activities and will be using the Definition resources and the use of the Definition resources to create orders, i.e., order entry. It will also provide some guidance on how to convert from the ODM-XML format to FHIR. Future iterations of the guide may include the actual implementation of the schedule and thus use the Event resources. This means of using FHIR to represent a structured schedule of activities will enable interoperability between CTMS and EHRs when the subject/patient scheduling for protocol/study defined activities is initiated. |
Project Facilitator | Jean Duteau |
Status | STU - Test Period/Accepting Comments |
SD Approval Date | Awaiting Approval |
TSC Approval Date | Nov 15, 2022 |
Project Type | Ballot - STU to Normative |
Objectives / Deliverables | FHIR IG R1 - Ballot STU in January 2023 |
Next Milestone Date | 2025 May WGM |
Project End Date | 2025 May WGM |
Project Intent | Create New Standard |
Project Need | Every research study has a number of activities that must be performed. Typically this is described in the study protocol as a succession of activities with a permissible interval between each one. For a specific Research Subject this is converted to a plan with actual dates. As the events occur a record is built up of the execution of the study for that specific subject. Less often thought about is the wider set of activities that go toward designing a study and setting it up. The mechanics of representation will be essentially the same but the consumers of the data are more likely to be the CRO (Clinical Research Organisation(s)) managing the study. This set of activities is likely to be completely independent of any patient record. Currently each software package used in the study holds its own representation of that schedule. This leads to repeated entry of the schedule frequently leading to differences in naming for a given event and omission of other events. Management and reporting of data during a study and subsequent aggregation of data are made more difficult. CTMS software packages that hold their own representation of a Study/Protocol schedule would ideally integrate with EHRs as well as other CTMS. Adoption of a FHIR based representation of the schedule will introduce consistency and avoid repeated data entry. It will facilitate uniform implementation of the schedule of activities across investigational sites. |
Success Criteria | |
Dependancies | |
Collaboration Efforts | |
Ballot Cycle Info | 2023 Jan Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Clinical Study Schedule of Activities, Release 1 |
Misc Notes | 2023 March: TSC approved STU Publication Request for Clinical Study Schedule of Activities Edition 1 |
Product Type | FHIR Implementation Guide |
Project Document Repository |
https://github.com/HL7/Vulcan-schedule-ig PSS: https://jira.hl7.org/browse/PSS-2003 |
Backwards Compatibility | N/A |
Stakeholders | |
Vendors | N/A |
Providers | N/A |
SDO/Profilers | |
Realms | Universal |
HL7 Affiliate | |
Roadmap Reference | |
Start Date | Mar 29, 2022 |
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