LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

ECF Teams and Projects

Principal Investigators’ Signatures
Kenichi Nakano
/ Categories: TEAMS STATUS and TYPE, Ended, Working Group

Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

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.

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