Electronic Signatures in Clinical Trials – 25 September 2025

With the pandemic it became apparent that we use electronic signatures on documents very often. Staff had to stay at home and the home office was even a requirement in some countries. Printing, signing, scanning, mailing the documents for approval and sending the originals with postal mail is tedious. On the other hand the electronic signature systems offer the possibility to sign with a click. This sounds great and it has been widely used without further ado.

But once you look into a TMF you will find a complete chaos regarding signatures: wet ink scans mixed with different electronic signatures.

This presentation shall give an answer to the following and more questions:

• What is a valid and compliant signature?
• Which regulations do I have to follow?

We need a pragmatic and compliant approach for signing and filing documents with electronic signatures.