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Good Clinical Practise (GCP)

GCP is an international standard ensuring ethical and scientific quality in clinical research involving human participants. It protects the rights, safety, and well-being of participants and promotes data credibility.
 

CALHN staff involved in clinical research, including investigators, research managers, and trial coordinators, must hold a current GCP certificate. Certification must be renewed every three years or when there are updates to the ICH GCP Guidelines. The training equips staff to confidently carry out their roles in the research process.

CALHN offers TransCelerate accredited GCP training, delivered by certified trainers. In person sessions, held at the Royal Adelaide Hospital or The Queen Elizabeth Hospital cover:

  • GCP standards and their importance.
  • Study setup, responsibilities, approvals and essential documents.
  • Informed consent.
  • Case report forms, data entry/completion, and source data.
  • Safety reporting.

Upcoming GCP Sessions
Location

26 May 2025

Royal Adelaide Hospital

22 August 2025

The Queen Elizabeth Hospital

24 November 2025

Roma Mitchell House

GCP certifications can be renewed through registered online training modules. Online GCP training modules can be accessed online.

CALHN also offers a short introduction to GCP module that can be delivered to staff external to the research trial but who still deliver care to trial participants within CALHN.  These groups may include:

  • nurses
  • pharmacists
  • radiologists
  • pathology staff
  • interested parties.

Australian Clinical Trials Education Centre (A-CTEC) has helpful self-paced, online learning modules which are provided at no cost to participants.

Available subjects can be found on the A-CTEC website

"

If you are a researcher who is looking for a worthwhile GCP course, I highly recommend the face to face training over the online option to get this certification. I recently had to renew my GCP and found this face to face course infinitely more informative, useful and engaging in comparison to the online version. The presenters who gave the lectures were knowledgeable, enthusiastic and had lots of CALHN specific research experience which gave context and advice which I did not gain from the on line versions. There were lots of opportunities for questions, discussion and networking with the other participants. Excellent course. Well worth the time.

Associate Professor Cynthia Papendick, Research Director CALHN Emergency Departments
"
"

Offering face to face GCP training for all team members has helped create a broader and deeper understanding of the benefits of good clinical practice in every day clinical research, QI/QA and further afield, to prepare for Sponsored trials. It is invaluable not just for the experience and leadership your team provides, but also for the networking and ongoing support. I highly recommended this course.

Associate Professor Gabrielle Cehic, Clinical Lead SA PRRT Service
"

To find out more contact

This page was last updated April 23 2025.

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