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Event date: 12/1/2020 Export event
Technology Showcase: Target Health – Challenges to the Adoption of Paperless Trials During the COVID-19 Epidemic and Beyond
Open To: Staff from eClinical Forum member companies. For information on eCF membership, please see www.eclinicalforum.org/membership or send an inquiry to info@eclinicalforum.org.
Background: This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. For more information, please reply to info@eclinicalforum.org.
Presenter: Dr. Jules Mitchel, Target Health
About this Topic: Clearly, the implementation of traditional clinical research studies as well as executing COVID-19 studies themselves. have been dramatically impacted by global COVID-19 pandemic. Since showing up at clinical sites in general is becoming less feasible, clinical research must adapt. While there are many exciting ideas to execute virtual and remote studies, the focus still needs to be on the assurances that 1. the clinical sites understand and are following the protocol; 2. the data can and are being entered and reviewed in “real time,” 3. there are the “absence of errors that matter” and 4. the “data are fit for purpose.” This session will showcase several studies using a web-based application, with Informed Consent fully integrated with real time direct data capture, real time reports, online monitoring reports and safety reporting.
Date: Tues, December 1 2020 Duration: One hour
Time: Webinar at UTC 1500. This webinar will also be recorded so that all eCF Asia-Pacific members and other members who have time conflicts can review at a more convenient time. Please also register if you are interested in the recording.
eClinical Forum Membership registration: https://eclinicalforum.org/Forms/TS-Paperless-Trials
Non-members: Please review membership information on this website in the membership tab, or contact us for more information: info@eclinicalforum.org
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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.
