CRDO Workshops: Clinical research, skills and practice workshops

For RCH staff, please enrol on LearningHero by contacting Sarah Rathjen at show email address .

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.

All key trial personnel must have a valid Good Clinical Practice (GCP) Certification (certificates are valid for three years). This is a requirement as per the RCH Investigators Responsibility in Research Procedure (RCH0498). 

For more information see MCTC200 Factsheet | Documentation of Key Personnel (on the Metis Document Library).

“If the research is a clinical trial, the PI must ensure that the investigative team have successfully completed Good Clinical Practice (GCP) training within the last three years using a TransCelerate-accredited course; this includes all investigators, study coordinator, research nurse, pharmacist, and anyone undertaking a trial-specific procedure that is additional to standard of care. It is strongly recommended that all investigators for other clinical research also complete GCP training.” 

Most HRECs and Pharmaceutical industry sponsors also require certification from a TransCelerate BioPharma, Inc recognised GCP course.

The CRDO training program is a practical presentation of the principles of GCP in the Australian context. The course is designed so researchers know how to apply these principles to all research, in alignment with regulations and legislative requirements. 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 A-CTEC. This course is free but does require you to have an account with A-CTEC. This course was designed by CRDO and is also 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 A-CTEC: Good Clinical Practice = Good Research Practice to enrol (free).

Visit A-CTEC: New Account Sign-up to set up an A-CTEC account (free).

Please note: The A-CTEC GCP Course is not Victoria nor paediatric research specific. We recommend that all researchers new to the Melbourne Children’s Campus attend the free CRDO workshop where possible.

If you cannot attend a face-to-face session once your CRDO certification has expired, the A-CTEC 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, as this forms part of our training records.

It is essential for Study Coordinators and Investigators working in clinical trials involving therapeutic goods (medicine or device) to understand the NHMRC regulations governing safety monitoring and reporting.

This workshop will:

• Clarify terminology
• Cover the responsibilities of all stakeholders (Sponsor, Investigator, HREC and Institution)
• Describe the process for submitting safety reports to HRECs and Research Governance Offices.

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: completion of a TransCelerate-recognised GCP course within the last three years and completion of the CRDO workshop: “Safety oversight, monitoring & reporting”. Please contact CRDO if you would like to discuss further.

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.