Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1”.

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance with regulatory requirements and on risks such as reputation, credibility, and legal liability of the data being used by the sponsor. 

Building upon the relevant requirements regarding the investigator’s signature from the current global regulations and guidelines, it proposes the risk-based approach to the collection and control of the investigator’s signature on the eCRF data.  EDC functionalities are also recommended to better facilitate the collection and the monitoring of the investigator’s signature.  During the project, EMA issued the draft guidance titled “Guideline on computerised systems and electronic data in clinical trials” and the Working Group used this as an input in a timely manner. 

This is a significant accomplishment by the PI Signature Working Group who shared their experiences and insights which were crystalized as the best practice document.  We’d like to thank co-chairs Cinzia Piccini (Eli Lilly) and Babette von Hagen (CSL Behring), and each member of the Working Group for their invaluable contribution to the development of this document. 

This release is the public release, following the member release in April.