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