- Created by Jean Duteau, last modified by Geoff Low on Dec 15, 2022
Short Description | Designing an interoperable definition for Clinical Research activities is going to be a key driver for accelerating the reuse of healthcare data in accelerated delivery of treatments to Patients. This project is focused on using FHIR for communicating study designs, so that they could be incorporated into EHRs |
Long Description | With the productisation of the draft IG for Schedule of Activities we will need to work on formal advancement of the stability of the content therein in order to have the IG ready for ballot in the New Year. |
Type | Test an Implementation Guide |
Track Lead(s) | Mike Ward, Geoff Low, Jean Duteau |
Track Lead Email(s) | ward_michael_j@lilly.com; geoff.low@3ds.com; jean@duteaudesign.com |
Specification Information | Current Implementation Guide draft: http://build.fhir.org/ig/HL7/Vulcan-schedule-ig/index.html The SOA GitHub link: https://github.com/HL7/Vulcan-schedule-ig |
Call for participants | EHR Vendors; Study Design Software Vendors; Curious Implementers |
Zulip stream | |
| Track Kick off Call | TBD |
| Clinical Input Required? | Yes |
| Related Tracks? | 2023 - 01 Vulcan - Real World Data (RWD) for Research and Regulatory Submissions |
| Server | Name: InterSystems FHIR Server server endpoint: TBD version: r4 |
Testing Scenario: | Overview Research Study Dataset (SoA) Synopsis: As the implementations of Research Protocols using EHR systems increase there is a need for realistic sample study data covering the planning, execution and outcome of Study activities: There should be examples of:
As a extension we should consider coherent sample data infers that there should be some consistent change for the participant to cover the common use cases of no response, partial response, complete response to the study intervention. Investigational Product Administration Synopsis: A key point of reference in a Clinical Trial is the administration of Investigational Product (which may be a drug, therapy or procedure). Study Elements are defined relative to these interventions, sometimes very directly (eg PK study) or more indirectly (eg Screening versus Treatment Epochs) IP Administration Scenario 1: Using the LZZT protocol (see below);
IP Administration Scenario 2:
IP Administration Scenario 3:
IP Administration Scenario 4:
Unscheduled Activities Synopsis: Up until to now the Study Design has been limited to pure 'happy path' implementation; where each subject has a single path through the study. More practically it is known that there can actually be variations in what datapoints are expected for a study participant as part of the activitie s Unscheduled Activities - Scenario 1
Unscheduled Activities - Scenario 2:
Unscheduled Activities - Scenario 3:
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