Investigator’s signature on electronic Case Report Forms (eCRFs)

There is increased scrutiny by regulatory agencies on the collection of investigator’s signature as evidence of the overall oversight on the eCRF data reported to the sponsor.
Due to different interpretation on the timing and frequency for the collection of the investigator’ssignature, an eCF Task Force has been formed to identify best practices that are based on the compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor. The intent of this document is to provide a framework for individuals’ risk‐based decisions and best practices for implementing solutions for investigators’ signature collection on data reported to sponsor.