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The current regulatory expectation is the investigators review and sign-off the data entered into eCRFs and other data collection tools at critical timings (including prior to interim analysis and the final analysis) in a timely manner. eClinical Forum issued a best practices document titled “Investigator’s signature on electronic Case Report Forms (eCRFs) in 2017. This team will review and align this existing document with most recent regulatory expectations on signatures collection on eCRF and eCOA data. A draft is anticipated in October 2021 and the release to the members by end of December 2021.
eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data
Log in to your eCF website account to see more:
RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities?
The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.
eCF Public Webinar March: Turning the ATRA Position Paper into Practice
This webinar focuses on practical implementations of the eCF industry position paper "Strategies for implementing Audit Trail Review"
The webinar is available to all our members as well as the general public. Date and Time: Thursday, 19 March 2026, 9:00 am EDT / 1:00 pm UTC. Sign up here
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)
Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30
Asia: Hosted by Novartis in Tokyo, Japan on April 2-3