The below information and links may be helpful to researchers at the Women's:
The Good Clinical Practice (GCP) guideline is the international ethics and scientific quality standard for conducting clinical trials.
In accordance with the National Clinical Trials Governance Framework, clinical trial investigators and their clinical teams must have access to - and undertake training in - the principles of GCP.
The Royal Women’s Hospital has adopted the International Conference on Harmonisation (ICH) GCP guideline for all clinical research studies conducted at the Women's.
What are the Women's requirements?
- All members of the Women's research teams must hold a current, valid GCP training certificate before they commence working on a research project. This includes Principal Investigators, Associate Investigators, Research Nurses and Research Coordinators/Managers, pharmacists, and anyone undertaking a trial-specific procedure that is additional to standard care.
- A valid GCP training certificate must be uploaded via the SSA form in ERM for all staff before the start of a research study at the Women's.
- Researchers must forward copies of their certificates to the Research Office.
Good Clinical Practice Training
The GCP training course must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on their website.
You can access a free online course provided by the Australian Clinical Trials Education Centre (A-CTEC). This course is free but does require you to have an account with A-CTEC.
This course is TransCelerate-recognised and tailored to the Australian regulatory environment.
Further action:
Set up an Australian Clinical Trials Education Centre account.
Enrol in Australian Clinical Trials Education Centre training.
The Women’s is committed to improving the health and wellbeing of women and newborns through research and innovation.
Funding is vital in advancing research and its translation into clinical practice.
Research grants and funding support can be sourced via the Australian Government, Victorian Government, donations and bequests, philanthropic grants and research partners.
Links to grant funding opportunities can be found under ‘Research’ on the Women’s staff intranet.
You may have also have to source paid external statistical advice depending on the complexity of your needs.
See below for options for external statistical consultation:
Statistical Consulting Centre (The University of Melbourne)
Public Health and Preventative Medicine (Monash University)