Introduction to GCP R3

You are invited to attend an in-person Good Clinical Practice (GCP) R3 training facilitated by Sophie Mepham. This course is focused on addressing and complying with the changes made in the new version of GCP; ICH-GCP E6 R3. It is targeted as a refresher course for principal / sponsor investigators and key clinical trials management staff.

This course will include:

• GCP – The standards and why we have them.
• Key differences between ICH-GCP R2 and R3 and how to address these changs.
• Roles and responsibilities in clinical trials and essential documents
• Informed Consent
• Case Report Form, Source data and protocol compliance
• Safety reporting

RSVP & Dietaries

This course is supported by the Office of Ethics & Integrity, resulting in the training being free for researchers.

NB: The course cost of ~$215 per participant will be covered by Clinical Trials Governance and Sponsorship. However, in the event of non-attendance it may be charged to the researcher’s cost centre. We ask that attendees please notify us early if plans change to enable another person to attend.

Lunch will provided. An afternoon break will also be provided in the afternoon, please feel free to bring additional snacks for this break. Please advise of any dietary requirements when registering for this event by 27th February 2026.

CPD Certification

Sophie Mepham Introduction to GCP is accredited by the CPD Certification Service as meeting the highest levels of CPD learning standards. Applicable staff attending the Introduction to GCP program, at 6 hours long, can claim 6 CPD points.

Notification to collection information

As a part of completing the GCP certification, we will be sharing your name and institution email address with our external GCP facilitator, Sophie Mepham, for the purpose of circulating a quiz and consequent GCP certificate. Please reach out to the clinical trials governance and sponsorship team research integrity team ([email protected]) by Friday 27th February 2026 if you do not wish for your information to be circulated.

Event Venue & Nearby Stays

Deakin Downtown, 727 Collins Street, Melbourne, Australia

Concerts, fests, parties, meetups - all the happenings, one place.

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