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.