Australian Clinical Trials Education Centre

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.

Thank you to everyone who joined our August webinar exploring the evolution and practical application of teletrials across Australia, delivered by nationally recognised teletrial leaders. The session sparked valuable discussion on improving access to clinical trials, supporting connected care, sharing lessons from implementation, and the future of innovative trial delivery.

If you missed the webinar, or would like to revisit the discussion,

The recording and presentation slides are now available on A-CTEC.

Join Simone Knab for a practical webinar focused on simplifying compliance and building confidence in implementing the new GCP R3 requirements. Simone will introduce a modified ISF structure designed to align with the new requirements, helping hospital sites meet expectations without creating unnecessary workload.

The key message is simple: don't panic and don't overcomplicate it.

Through a clear, practical framework, Simone will outline how sites can adapt their ISF to the new requirements while keeping documentation processes manageable, efficient and inspection-ready. 

Register Here