Not all sponsor requirements are straightforward, and electronic signatures are a good example. This real-world enquiry generated extensive discussion amongst A-CTEC's Education Advisory Committee, with members sharing their experiences, interpretations, and approaches to managing FDA 21 CFR Part 11 requirements in Australian clinical trials.

Explore the scenario on the A-CTEC platform to discover the key considerations, practical solutions, and range of perspectives shared by fellow clinical trial professionals.

If you have an operational scenario, question or experience that could benefit from broader discussion, we would love to hear from you. Share it via the A-CTEC platform or email us at education@actec.org.au.