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Event date: 9/9/2020 Export event
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)
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
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.
BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download
The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.
We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.
Facilitated by Carmen Jiménez, Eli Lilly