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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: 10/15/2017 - 10/18/2017 Export event
We are happy to announce that our Autumn meeting will be held at the Babson Executive Conference Center in Wellesley MA on Oct 16-18 2017. Thank you to eClinical Solutions for hosting us in such a nice location. It is 35 mins from Logan Airport and 25 mins from the Amtrak station in Boston Back Bay. This is a full-featured executive conference facility which includes guest rooms and dining areas.
A Preliminary Agenda will be sent by end of July. Please send suggestions for topics/presenters to firstname.lastname@example.org.
Please reserve your guest room ($199 includes breakfast and wifi): Room block is being held for our group until Sept 16 (after that, rooms reservations are if available). Guest room reservations can be canceled up to 7 days prior to arrival.
Our group code is: ECLN17
Please register for the eClinical Forum meeting: https://www.surveymonkey.com/r/eCF_NA_Oct2017
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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.