GCP certification
Alfred Health investigators undertaking clinical trials and other interventional studies must have and maintain appropriate, accredited training.
Monash Partners has a policy on standards for Good Clinical Practice (GCP) training and GCP certificates which applies to researchers at any of the Monash Partner member institutions. Alfred Health is a member institution.
The policy has been developed as a means of mitigating the risk to participants, participant information and the integrity of the research.
The policy not only applies to those acting in the role of Principal Investigator but to researchers engaged as Associate Investigators and Research Co-ordinators listed in the ethics and/or site authorisation application to Alfred Health, irrespective of which institution they are from.
The minimum training standard is a TransCelerate Biopharma Inc accredited, ICH E6 Good Clinical Practice course. A list of accredited courses can be found on their website.
Whilst NIH National Drug Abuse Treatment Clinical Trials Network (NIDA) GCP training is not a TransCelerate accredited course, NIH courses that stipulate GCP will be accepted.
Researchers who have completed ICH GCP training should submit their training certificates to the Office of Ethics and Research Governance.
From 01 January 2018, any researcher listed on a new application and/or included on an ongoing application, who has not provided evidence of acceptable research training, will not be able to undertake research with an Alfred Health component until they have complied with the requirement.
Researchers are also required to maintain their training by completing a TransCelerate accredited ICH GCP refresher course every three years.
Training opportunities are promoted as they arise. Find out more about researcher training.