NEWS FROM THE ECF

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

Best Practices

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.

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Webinar:  "Strategies for Implementing Audit Trail Review"

eCF Webinar:  "Strategies for Implementing Audit Trail Review"

The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.

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