Informed Consent in Clinical Trials
Informed consent is one of the most frequently cited areas in TGA inspections of clinical trial sites. This interactive workshop builds on the foundations covered in Informed Consent Essentials, with a focus on how consent works in practice in clinical trials, and how to get it right. We recommend completing the Informed Consent Essentials workshop first, but it is not mandatory.
Using recent TGA inspection findings as a starting point, you will review current consent practice, work through the consent process from start to finish, and take on the role of auditor to review consent documents. The workshop also covers:
- Consent version control and re-consenting when documents change
- Waivers of consent
- Electronic consent, including what makes an electronic signature legally effective and which systems are suitable for MCRI researchers
Who should attend: Research coordinators, investigators and others involved in the consent process for clinical trials.
First delivered: July 2026. The workshop will run again in 2027, with dates available on this page by December 2026.
- Format
-
In-person
- Duration
- 3-4 hours
- Cost
- Free for Melbourne Children Campus members. $350 for external participants.
- Register now