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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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Event date: 9/26/2017 1:00 PM - 9/28/2017 3:30 PM Export event
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…
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'.
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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.
