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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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In November 17, 2016, the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) released E6 R2 which tries
to address some of major developments in technology, medical breakthroughs and
business processes – taking into account unprecedented yet justified
expectations by regulators, patients, investigators and caregivers.
The eCF webinar explored what was removed and discussed some of the
opportunities and challenges presented by additions to the E6 text:
Slides used during the event can be downloaded by eCF members from the Members
area of the website.
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We wish you a Happy New Year 2021
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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.