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eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

Wednesday, 17-Nov-2021

Event date: 17/11/2021 Export event

eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

eCF Webinar:  Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

Date:  Wednesday, 17-Nov-2021      Duration: One hour

Presenters:   Michael Van Campen (Vulcan Program Manager), Hugh Glover (Vulcan Technical Director), Amy Cramer (Vulcan Steering Committee Co-Chair)

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.

For This Topic:  

    • HL7 FHIR (Fast Healthcare Interoperability Resources) is a standard describing data formats and elements and an application programming interface for exchanging electronic health records. The standard was created by the Health Level Seven International health-care standards organization.
    • Vulcan is an HL7 FHIR Accelerator that brings together stakeholders from across the translational and clinical research communities in order to bridge existing gaps between clinical care and clinical research, strategically connect industry collaboratives, maximize collective resources, and deliver integrated tools and resources.
    • HL7 FHIR is the path forward to bridge clinical care and clinical research. A global collaboration between all translational and clinical research stakeholders to co-develop out the standard, it will allow for a reproducible, scalable process for data exchange. The presenters will share not only the conclusions drawn from use cases developed up to this point, but will also provide insight into the future direction and priorities of Vulcan.  

Time:  This webinar will be offered at one time only at UTC 1600. Apologies to those in which this time is inconvenient. We will be recording this session and we request that you indicate on your registration if you are coming to the live session or would like a link to the recording sent to you the following day.

For Registration:  Please send a note to webinars@eclinicalforum.org

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eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

We will be discussing a recent eCF/EUCROF positions paper: 

The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

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