SERVICE
NEW
Governance in Clinical Trials Core Skill Set
The National Clinical Trials Governance Framework is a step towards consistent accreditation of clinical trial sites.
PRAXIS has been contracted to develop training on behalf of the Australian Commission on Safety and Quality in Health Care. This training will be delivered by the Commission to assessors who will be reviewing Australian clinical trial sites against the Framework from 2023.
To help clinical trial and research staff prepare for these changes, PRAXIS have developed this new course.
Who is this for?
All research and clinical trial staff working in health care or related clinical trial support roles.
What will you learn?
On completion, you will:
- Understand research governance principles and processes, guiding documents, and the key elements and critical factors for a timely and efficient review process
- Have the skills and knowledge to conduct clinical trials that are safe and appropriate to the diverse cultural beliefs and practices of consumers
- Know the basic concepts and principles of risk management and how to control and reduce risk in your projects and clinical trials
- Understand the tools and skills you need to ensure your research projects and trials are managed to the highest quality and adhere to applicable regulatory and GCP standards
- Have a better understanding of how you can involve consumers and patients in your research
- Be familiar with the Australian privacy laws, principles, and policies that are relevant to your research
- Be able to to assess and manage privacy risks in your projects
- Understand the roles and responsibilities in safety monitoring and reporting, and safety reporting requirements for Investigators and Sponsors conducting clinical trials
- Know the appropriate alternative models of consent and different strategies for obtaining consent
What's included
- Principles of Research Governance (EC.04)
- Quality Assurance for Clinical Trial Sites (C3.07)
- Risk Management in Research (C5.04)
- Safety Monitoring and Reporting in Clinical Trials (EC.03)
- Data Management: Privacy, Security, and Governance Across the Lifecycle (C4.04)
- Consumer and Patient Involvement in Research (EC.11)
- Cultural Safety in Research (C2.06)
- Consent to Research (C2.10)
Price
$1049 + GST (valued at $1900)
*Savings available for group enrolments and for PRAXIS partner organisations.
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.