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Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

Offered on September 9 2020

Event date: 9/9/2020 Export event

Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eCF Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

This webinar will discuss:

  • What is the Sponsor’s responsibility regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities?

  • What are the benefits of all sites and all sponsors and all CROs using a common assessment tool?

  • What is eSRA?
        - Developed by the eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and
          Clinical Research Services industry, along with sites and academia
        - Based on regulatory requirements in EU, US and Japan;
        - An assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data;
        - Available for free for over 4 years and currently being used around the globe by many sponsors and thousands of sites;

  • Japanese translation of eSRA Handbook ;

  • How a Sponsor/CRO can incorporate eSRA into their processes.

Date/Time:  Wed Sep 9 at UTC 0700 (Japan: 1600)
Language: Japanese
Duration: One hour
Presenter:  Kenichi Nakano - eClinical Forum Asia Pacific Facilitator

To register for this free webinar, please follow this link:  https://eclinicalforum.org/Forms/ESRA_Japan_9Sep20  --- PLEASE NOTE: WE WILL USE YOUR EMAIL ADDRESS FOR SUPPLYING INFORMATION FOR THIS WEBINAR AND NOT FOR ANY ADVERTISING

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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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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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Upcoming events Events RSSiCalendar export

  • DETAILED AGENDA: eClinical Forum Virtual Workshop, 12-16 October 2020 (10/12/2020 - 10/16/2020 UTC)
    10/12/2020 - 10/16/2020 UTC
    103

    DETAILED AGENDA: eClinical Forum Virtual Workshop, 12-16 October 2020

    We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

    Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

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