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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: 12/4/2017 - 12/5/2017 Export event
next meeting of the Asia Pacific Forum will be held at Quintiles IMS in Tokyo, Japan on 4-5 October 2017. Thank you to Quintiles IMS for hosting us in such a nice location.
The objectives of the meeting are to…
A draft agenda will be issued shortly. Please send suggestions for topics/presenters to email@example.com
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.co.uk/r/ECF_TOKYO_DEC2017
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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.