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Principal Investigators’ Signatures

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

  • 4 March 2021
  • Author: Kenichi Nakano
  • Number of views: 7180
  • 0 Comments
Principal Investigators’ Signatures

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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eCF Views & News

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Registration for the eCF Asia Autumn workshop is now open!

Registration for the eCF Asia Autumn workshop is now open!

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.

The workshop will be available for in-person participation only. There will be a networking/social event in the evening.  Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here

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Registration for the eCF Asia Autumn workshop is now open!

Registration for the eCF Asia Autumn workshop is now open!

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.

The workshop will be available for in-person participation only. There will be a networking/social event in the evening.  Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here

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