From
August 2016, Monash University will offer TransCelerate accredited ICH Good
Clinical Practice Training in clinical research, expected and recognised by
pharmaceutical companies in commercially-sponsored clinical trials.
ICH
GCP is also increasingly a requirement of human research and ethics committees.
Training
is available to all paid employees of the Monash Partners organisations, funded
by the Partners at no cost to attendees. It is offered at two sites: the Alfred
Medical Research and Education Precinct (AMREP) and the Monash Health
Translation Precinct (MHTP). Subject to demand, training may also be available
at other Monash Partners sites.
The
training program is delivered by trained GCP facilitators with extensive
experience in clinical research and consists of:
ICH
GCP Training:
a 5 hour face to face interactive workshop, designed for those involved in
pharma or clinical research, including Principal Investigators, Associate
Investigator and Clinical Trial Coordinator responsibilities.
The
course consists of five modules: The Standards, Study Set Up, Informed Consent,
Case Report Form and Data Entry, Safety Reporting.
Refresher
ICH GCP: a
2 hour face to face workshop, available from September 2016. Information about
eligibility for this program will be available on the website.