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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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Birds-of-a-Feather Round Table Discussion:  New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.

The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.

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