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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.


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Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

August 18, 2020

Event date: 8/18/2020 Export event

Birds-of-a-Feather Round Table Discussion:  U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

Birds-of-a-Feather Round Table Discussion:  U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

Date:  Tuesday, August 18, 2020  Duration: One hour, starting at UTC 1500 (8amPDT, 10amCDT, 11amEDT, 4pmBST, 5pmCEST)

Facilitator:   Ken Light, Clinscape

Open To: Staff from eClinical Forum member companies gratis. If you are from an eCF Member Company (see list on our Membership tab) then please register using this link: http://eclinicalforum.org/Forms/BoF1.. 

(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. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic:  

In 1996, HIPAA legislation called for the development of a national patient identifier system that would give each person in the United States a permanently assigned, unique number to be used across the entire spectrum of the national healthcare system.   That project was never funded by congress, but just last year (June, 2019) Congress voted to appropriate $99 billion dollars to an HHS bill that included creation of a National Patient Identifier.

Ken Light will review this topic, and oversee a group dialog around the benefits, challenges, and impact related to healthcare and clinical trials.   The agenda for this session includes:

  • Background:  
    • What is NPI and why is it needed?
    • History of NPI in the U.S. - Why U.S. doesn’t have one yet
    • Why NPI is used in other countries but not used in the U.S.
  • Benefits and Challenges
    • Short discussion of how this will be used, helpful, applied in our world of clinical trials
  • Global Trials
    • How will this apply to global trials - will the use of a U.S. NPI just complicate things?   
    • Any other complicating factors/risks?
  • Implementation
    • How this might be best implemented, keeping in mind the requirements of GDPR, HIPAA, Part-11, blinded studies, etc.
  • Group Discussion, Questions, Ideas
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9/9/2020 UTC
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Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

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9/23/2020 UTC
109

BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

                                Miko Pietilä, Signant Health, eCF Audit Trail Review Team

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