CRDO will continue to run workshops as scheduled online through Zoom for the foreseeable future.
This means that:
- Enrolment is open
- Everyone currently signed up to a workshop is still enrolled
- Those who attend the Zoom meeting will receive certification
If you have any questions or need help to set up Zoom please email email@example.com
All workshops are free for all Melbourne Children's staff and students. Melbourne Children's includes anyone who is an employee/student/honorary of the Murdoch Children's Research Institute, the University Of Melbourne Department Of Paediatrics, or The Royal Children's Hospital. The cost of the workshops for external participants (i.e. those who are not affiliated with Melbourne Children's) is $350 per workshop.
These 3 workshops are targeted at those working in, or wishing to enter, the clinical and public health research field. Those with experience in research as well as those new to research will benefit from the workshops. The training is applicable to Study Coordinators, Research Assistants, Principal Investigators and Students. Note that these are not intended to be taken sequentially or as a series - just enrol in those you are interested in.
The ethics revew process
Understand the Ethics and Governance requirements pre- and post-approval. From a new project application through to submission of the final report and everything in between, discover what the HRECs and Research Governance Offices require from you, when it's required and why.This session will also demystify the new Ethics Review Manager (ERM) system, the Human Research Ethics Application (HREA) Form, and the Victorian Specific Module (VSM).
Informed consent essentials
Understand the different types of consent and how to write and communicate in plain English. Obtaining valid consent is a vital, active and ongoing process in research. In this workshop you will learn why informed consent is required, what it is and how to obtain it. This workshop will focus on how to write high quality Participant Information and Consent Forms (PICFs) and on the role of communication in the consent process.
Good clinical practice (GCP) = Good research practice
All Key Trial Personnel must have a valid Good Clinical Practice (GCP) Certification (certificates are valid for 3 years). The CRDO training program is a practical presentation of GCP in the Australian context, covering the principles of Good Clinical Practice (GCP). The course is designed so researchers know how to apply these principles to all research, in alignment with regulations and legislative requirements.
Most HRECs and Pharmaceutical industry sponsors require a TransCelerate BioPharma, Inc recognised GCP Certificate, which is certified to meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training, based on ICH E6 R2. The CRDO course is registered with TransCelerate BioPharma, Inc, and will therefore be accepted by most organisations in the Australian clinical research industry.
As an alternative to CRDO’s course, you can access an online course provided by Genesis Research Services. Their course is free, Transcelerate-recognised, and tailored to the Australian regulatory environment. We recommend the online option to those unable to attend our face-to-face CRDO workshops. Visit Good Clinical Practice (ICH GCP) Course - Genesis Research Services to enrol.
Please note: The Genesis Research Services GCP Course is not Victoria nor paediatric research specific. We recommend that all researchers new to the Melbourne Children’s attend the free CRDO workshop where possible.
Should you require a refresher course once your CRDO certification has expired, the Genesis course is a great alternative to CRDO’s face-to-face workshop. Please ensure you save the GCP certificate issued in your files and send a copy to CRDO if you would like a reminder to renew your GCP certification.
CRDO collaborates with Clinical Epidemiology and Biostatistics Unit (CEBU) and the Melbourne Children’s Trial Centre (MCTC) as well as other Campus groups to conduct specialised workshops and conferences throughout the year. We recommend that those attending the Specialised workshops are either experienced in Clinical Trials, or have attended CRDO's Core Workshops.
Safety oversight, monitoring & reporting
It is essential for Study Coordinators and Investigators working in clinical trials to understand the NHMRC regulations governing safety monitoring and reporting. This workshop will:
cover the responsibilities of all stakeholders (Sponsor, Investigator, HREC and Institution)
describe the process for submitting safety reports to HRECs and Research Governance Offices.
Monitoring investigator-initiated clinical trials (IITs)
Available only for campus staff & students: Familiarise yourself with the what, when and how of monitoring a clinical trial. Good Clinical Practice requires that the Sponsor ensure that their clinical trial is adequately monitored. For Investigator-Initiated Trials (IITs), the Sponsor responsibilities are shared by the institution and the Coordinating Principal Investigator (CPI), so it is essential that the CPI and team understand these obligations and how to fulfil them. In this workshop, we will explore what is involved in determining the level and type of monitoring required (using a risk-based approach), developing a clinical monitoring plan, conducting the monitoring and reporting on it. This workshop is essential for Study Coordinators and Investigators leading IITs.
Pre-requisites: completetion of a Transcelerate-recognised GCP course within the last 3 years and completion of the CRDO workshop “Safety oversight, monitoring & reporting” (please contact CRDO if you would like to discuss further)
Budgeting for research
Available only for campus staff & students: This workshop will increase your understanding of key finance and budgeting terms, the importance of accurate budgeting, how to develop a fully-costed budget, tips on how to monitor your budget, budgetary implications of grant funding and more.
Other training on campus...
CEBU offers short courses in the key aspects of clinical research design, data management and analysis go the CEBU website to enrol.
The MCRI Human Resources team runs a number of workshops that are useful for those working in research (for MCRI staff & students) covering soft skills such as influencing, negotiating and how to have difficult conversations.