This package of short course modules provides research office staff with essential foundational knowledge of the research ethics and governance review process in Australia, tailored to the specific responsibilities and expectations of their role.
Targeted audience: Research Office Staff : Ethics, Governance, Compliance and Development
The package has been developed by A-CTEC Education Working Group of Subject Matter Experts.
Currently available modules:
- Module 1: Introduction to Ethics
- Module 2: Ethics Review Process
This package will be updated with more modules as they are completed.
Target Audience: all members of the study team and anyone who works in clinical trials, but the content is applicable to all forms of Human Participant Research, not just clinical trials.
- The aim of this course is for you to become GCP-certified.
- Expected time for completion: 2.5 hours
Target audience: Data managers, investigators, study coordinators, unit managers, quality/project managers, trial statisticians
This package includes 2 courses :
- Part 1- Data management planning
- Part 2- Data surveillance, storage and sharing
This introductory package of 5 courses will equip trial investigators with foundational knowledge about overseeing and managing clinical trials in Australia.
- Trial Regulatory Requirements in Australia
- Trial Feasibility & Start-up Process
- Safety Monitoring and Reporting in Trials
- Protocol Compliance & Serious Breaches
- PI Oversight and Trial Management
This package is mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R2) GCP.
This introductory package of 6 courses will equip the research support team with foundational knowledge about running clinical trials in Australia.
- Introduction to clinical trials
- Running clinical trials from start to finish
- The regulatory environment of clinical trials
- Ethics and governance application process
- Safety reporting in clinical trials
- Monitoring and auditing clinical trials
This package is mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R2) GCP.
This package of 3 short courses (modules) will equip trial researchers with foundational knowledge about the research ethics and governance process in Australia, with specifications to Victorian requirements.
Targeted audience: Investigators, Research Nurses/Coordinators, Clinical Trial Assistants
The package has been developed and kindly shared by Murdoch Children’s Research Institute, Victoria, Australia.
- Module 1: Key Concepts
- Module 2: Initial Submissions
- Module 3: Post Approval Reporting
This advanced package of 7 short courses (modules) aims to upskill clinical trial professionals with the business skills they need to successfully run a clinical trial unit
Target Audience:
- Trial Unit Managers
- Experienced Research Nurses/Coordinators