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eCF Europe 2017 Workshop. Hosted by Bayer, Berlin, 26-Sep to 28-Sep 2017

Location: Steigenberger Hotel Berlin

  • 11 July 2017
  • Author: Webmaster1
  • Number of views: 8308
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Event date: 9/26/2017 1:00 PM - 9/28/2017 3:30 PM Export event

eCF Europe 2017 Workshop. Hosted by Bayer, Berlin, 26-Sep to 28-Sep 2017

We are happy to announce that our Autumn meeting will be held at the Steigenberger Hotel in Berlin, Germany on 26-28 September 2017. Thank you to Bayer for hosting us in such a nice location.

The objectives of the meeting are to… 

  • Leverage the knowledge of eClinical Forum members to remain up-to-date on current thinking and to explore emerging technology, process, people and regulatory trends
  • Drive performance by developing an unrivalled insight into global best practices, risks and opportunities
  • Design the future of eClinical Research by working with peers to develop leading-edge visions and implementable strategies
  • Build a network with global experience and insight for beyond-the-workshop interaction
A draft agenda will be issued shortly. Please send suggestions for topics/presenters to info@eclinicalforum.org.
Membership of the eClinical Forum will be required to attend the meeting. If you aren't yet a member and would like to join, then this can be arranged easily and cheaply. Please don't hesitate to contact us to discuss your membership requirements.

Please register for the meeting: https://www.surveymonkey.com/r/ECF_Berlin_2017

Please reserve your accommodation (169 EUR includes breakfast) by contacting the hotel directly and quoting reference 'ECLINICAL FORUM 2017'.

Steigenberger Hotel Berlin

Los-Angeles-Platz 1
10789 Berlin
Germany
+49 30 21270

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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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