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  1. Project Scope Statements/Proposals
  2. PSS-2171

Adverse Event Clinical Research Implementation Guide

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    • Resolution: Done
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      There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. The Clinical Research use does not correspond to 80% of core as seen by Clinical Care but is within the 80% for Clinical Research.  Discussion between the two viewpoints over several years leads each time to a conclusion that there should be two distinct resources. However, since most of the attributes would have the same names, just variants of the definitions, defining 2 domain specific implementation guides for the AdverseEvent Resource seems more appropriate. Since current AE implementations are based on FHIR R4.0.1, there will be an IG based on FHIR R5.0.0 and an IG backported to R4.0.1 to support existing implementations.

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      There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. The Clinical Research use does not correspond to 80% of core as seen by Clinical Care but is within the 80% for Clinical Research.  Discussion between the two viewpoints over several years leads each time to a conclusion that there should be two distinct resources. However, since most of the attributes would have the same names, just variants of the definitions, defining 2 domain specific implementation guides for the AdverseEvent Resource seems more appropriate. Since current AE implementations are based on FHIR R4.0.1, there will be an IG based on FHIR R5.0.0 and an IG backported to R4.0.1 to support existing implementations.
    • Biomedical Research & Regulation
    • Devices
      Patient Care
    • Vulcan
    • Mike Hamidi, Pfizer; Christi Denney, Lilly; CDISC, FDA; HL7 CIC WG
    • Flatiron; PatientLink/MyLinks
    • Filter by
      Product Family Product Project Intent Lineage Ballot Type Target Cycle Actions
      1
      FHIR
      Implementation Guide
      Create New R1 Standard
       
      STU
      September 2023
    • Vulcan Adverse Events; Vulcan AE
    • N/A
    • Unknown
    • No
    • No
    • Academic/Research, Association/Goverment Agency, Healthcare IT Vendors, Patients, Pharmaceutical/Biotech, Regulatory Agency, Vendor/Manufacturer
    • Universal

      Adverse events (AE) are tracked and evaluated as part of the clinical research process in a research study, as the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In the research setting, an Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.

      The IG (one based on R4 and one on R5) will model the data elements to support the workflow for collecting and reporting serious and non-serious AEs in clinical research to meet the need of regulatory requirements. This will require further profiling and extending the AdverseEvent resource to ensure appropriate representation. Therefore, allowing AE representation in systems, including EMRs and PHRs, transmitted via FHIR to other systems; removing the need to transcribe AE data into secondary clinical trial management systems and improving efficiency for health authority reporting.

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            Unassigned Unassigned
            mcasagni Michelle Casagni
            Michelle Casagni Michelle Casagni
            Bret Heale Bret Heale
            Bret Heale Bret Heale
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