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  1. Project Scope Statements/Proposals
  2. PSS-2003

Clinical Study Schedule of Activities FHIR Implementation Guide

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    • Icon: Project Scope Statement Project Scope Statement
    • Resolution: Done
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      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.

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      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.
    • Biomedical Research & Regulation
    • Clinical Decision Support
    • Vulcan
    • Hide
      Eli Lilly
      Phase
      TransCelerate
      Show
      Eli Lilly Phase TransCelerate
    • Product Family Product Project Intent Lineage Ballot Type Target Cycle Actions
      1
      FHIR
      Implementation Guide
      Create New R1 Standard
       
      STU
      January 2023
    • Vulcan Schedule of Activities
    • Yes
    • Academic/Research, Association/Goverment Agency, Healthcare IT Vendors, Pharmaceutical/Biotech, Regulatory Agency, Vendor/Manufacturer
    • Universal

    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.

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            jduteau Jean Duteau
            Jean Duteau Jean Duteau
            Jean Duteau Jean Duteau
            Jean Duteau Jean Duteau
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