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 cost of all workshops - free to 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.
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
The CRDO Good Clinical Practice (GCP) workshop meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary for mutual recognition of GCP training among clinical trial sponsors. This means that most pharmaceutical industry sponsors should accept the CRDO training course, and not require that you undertake company specific training. Most HRECs now also require researchers to have TransCelerate-recognised GCP certification. Alternative TransCelerate-recognised options are available free of charge only to Melbourne Children’s staff and students (RCH, MCRI, UoMP) in the form of on-line courses (contact CRDO at firstname.lastname@example.org for instructions on how to register). The following on-line courses, conducted via the CITI Program, are available: On-line GCP basic certification; and On-line GCP refresher certification (for those who have completed the CRDO Good Clinical Practice or another Transcelerate-recognised GCP course within the last 3 years).
The specialised workshops are available only to campus staff and students (RCH, MCRI, UoM Dept Paeds)
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. The specialised workshops scheduled for 2019 include the two new workshops on safety oversight and monitoring which were introduced in 2018, as well as the longer-running workshop on budgeting for research projects. Register below for these workshops.
Safety oversight, monitoring & reporting in clinical trials
Available only for campus staff & students Understand the new regulations governing safety monitoring and reporting in clinical trials using therapeutic goods. The requirements for safety monitoring and reporting in clinical trials has changed. The NHMRC has implemented a new guideline that introduces new terminology and requirements. This workshop will review the changes, clarify new terminology (What is an SSI? What is a USM?), cover the responsibilities of all stakeholders (Sponsor, Investigator, HREC and Institution) and describe the process for submitting safety reports to HRECs and Research Governance Offices. This workshop is essential for Study Coordinators and Investigators working in clinical trials.
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.
Keep in mind thatCEBU offers short courses in the key aspects of clinical research design 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.