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Clinical Trials

The Strategic Platform for Clinical Trials Support and Enablement aims to encourage and support high quality clinical trial activity within the partnership, streamline approval and governance processes, and improve patient access to, and recruitment into clinical trials. It seeks to support and nurture sector growth, financial return and sustainability for Maridulu Budyari Gumal partners and other key stakeholders.

Wide-ranging consultative processes have been used to develop a capability and capacity framework which will underpin the partnership's priorities in the coming years.

The work of the Platform is supported by the Clinical Trials Methodology Hub and the Research Ethics & Governance Steering Committees which include members from across Maridulu Budyari Gumal, but also from neighbouring health translation centres. 
 

Maridulu Budyari Gumal Clinical Trials Microsite

We are building a dedicated website for Clinical Trials information and the work of the Strategic Platform. The weblink will be here soon.
 

Platform Pillars

Clinical Trials Methodology Hub

A virtual facility to enhance and enable investigator-led clinical trial knowledge and activity, and to facilitate access to expertise in clinical trial design, methodology, biostatistics, health economics, consumer and community involvement and trial conduct.
 

Expertise Networks

We are building professional networks of industry experts such as Biostatisticians, Human Research Ethics Committees (HREC) Chairs and Clinical Trials Unit Managers to:

  • reduce professional isolation and encourage broad collaboration and innovation
  • enable the sharing of knowledge and expertise to build broad capacity
  • find solutions to overcome common problems
  • support and encourage career progression and employment stability through mentorship and ongoing education and training opportunities
  • collaborate with equivalent district, state and national professional networks
  • provide advice at the District, State and Federal Government levels.
     

Incubator Sessions

We are facilitating Incubator Sessions to support early- and mid-career investigators to develop clinical trial protocols. These sessions involve a multi-disciplinary panel of clinical trial experts and consumer representatives providing feedback and advice on ideas for clinical trials. This panel can also assist in the establishment of a multi-disciplinary investigator team and increase the quality of clinical trial protocols, funding and ethics applications. Investigators are also made aware of the procedures and processes required prior to trial commencement.
 

Resources for Best Practice Clinical Trial Start-Up

We will be providing a curated selection of state, national and international Clinical Trials Start-Up resources including an overview of requirements and weblinks to the ethics and governance resources of the partner institutions.
 

Clinical Trials Training Centre

We are working with training partners to deliver high quality, industry recognised training for clinical trial site personnel and members of ethics committees.

Our Good Clinical Practice training program, developed and hosted by Sophie Mepham GCP™ (SMGCP) is already up and running.

GCP training online and free to Maridulu Budyari Gumal partner organisations. Available now
Go to Maridulu Budyari Gumal site on the SMGCP website.

The online training covers:

Refresher GCP
Suitable for those who have already completed an Introduction to GCP and need to keep their knowledge current. A Certificate of Completion is awarded when the final quiz is completed successfully. The training meets the minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. It also meets the requirements for CPD credit points for eligible staff.

There is a ‘voice over’ version available as well as a slide-only version that can be worked through.

GCP Training for Associated Staff – Short Session GCP
Provides a very high level overview of GCP and clinical trials and is NOT TransCelerate or CPD accredited. The modules are suitable for staff who may see clinical trials patients as part of routine care, but who are not part of the core research team. There are sessions designed for staff in Nursing, Radiology, Pharmacy and Pathology.  A Certificate of Completion is awarded. Each module has ‘voice over’.

To access the online, self-directed training
The training is hosted on the SMGCP website. To access it for free as a staff member of a partner organisation, create an account. Please follow these steps:

1. Check that your organisation is a partner of Maridulu Budyari Gumal.

2. Go to Maridulu Budyari Gumal site on the SMGCP website.

3. Click on Enroll Free

4. To create a new account, enter:

  • Your name – the name that will be on the Certificate of Completion
  • Your email – enter a work-related email of a partner organisation. Don’t use a domain like Hotmail or Gmail
  • Your place of work – enter the name of the partner organisation you work for.

For more information on our GCP training contact gcptraining@thesphere.com.au
 

The Clinical Trials Strategic Platform Team

Rowena Tucker, Deputy Director, Maridulu Budyari Gumal
Dr Lucy Coupland, Clinical Trials Methodology Hub Coordinator
Merrilee Kessler, Project Officer Clinical Trials

Support Patient Care through Clinical Trials

Want to know more about the Clinical Trials Methodology Hub? Get in touch with Dr Lucy Coupland, Methodology Hub Coordinator for more information or support.

Want to know more about our GCP training options? Get in touch with Merrilee Kessler, Project Officer Clinical Trials for more information.