This page provides resources for all individuals and staff involved in clinical trials who are wanting to deepen their understanding of clinical trials, update their skill set, submit an application, and gain Good Clinical Practice (GCP) certification.
What is V-CTEC?
Victorian Clinical Trials Education Centre (V-CTEC) is a new free online training platform available to everyone involved in clinical trials across South Australia, regardless of their role or site. V-CTEC contains a suite of evidence-based, interactive clinical trials education modules, and is suitable to all levels of expertise, experience and competency.
Access to V-CTEC is funded by the SA/NT RCCC and the Office for Research in the Department for Health and Wellbeing, and the initiative is supported by Health Translation SA.
To access V-CTEC training modules please visit the webpage.
Good Clinical Practice (GCP)
Background
The International Council for Harmonisation (ICH) Guideline for Good Clinical Practice E6 (R2) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that involve participation of humans.
Compliance with GCP provides public assurance that:
- The data and reported results generated by clinical trials are credible and accurate.
- The rights, safety, well-being and confidentiality of clinical research participants are protected, consistent with the ethical principles that have their origin in the Declaration of Helsinki – this being the most important consideration, and should always prevail over interests of science and society.
An understanding of GCP in clinical trials is essential to maintain compliance with the Integrated Addendum to the GCP Guideline published by the TGA.
GCP Training
GCP certification is required for researchers and staff involved in the conduct of clinical trial with human participants. The certification must be renewed every 3 years.
To fulfill your GCP training requirements, SA Health recommends completion of V-CTEC’s Trials Essentials for Investigators or Trials Essentials for Research Support Team
course packages, as both are now mutually recognised as meeting the minimum requirements of ICH E6 (R2) GCP.
Upon completion of these packages in full, the certificates issued by V-CTEC include recognition that users will have met the minimum requirements for GCP training.
Teletrials
To support the Australian Teletrial Program (ATP) initiative in South Australia, the SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC) is committed to increasing access to training and development for all staff involved in clinical trials, and teletrials.
Our Training and Development Officer is available to connect clinical trial staff with the training they require, with the goal of facilitating their ability to participate in teletrials initiatives, and contribute to building capability and capacity in rural, regional and remote communities.
Contact the SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC) with any clinical trial and teletrial training inquiries:
SA Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Email: SARCCC@sa.gov.au
For more information please visit the teletrials webpage.
Australian Clinical Trials toolkit
For useful information and resources visit the Australian Clinical Trials toolkit for conducting clinical trials in Australia.