Elevate your clinical research practice
This microcredential equips research professionals involved in clinical research across pharmaceutical, medical device, health, public health, or allied health fields.
Developed in partnership with PRAXIS Australia and the University of Sydney, the course reflects international standards in clinical research practice. It emphasises ethical conduct, regulatory compliance, and pragmatic trial management.
Delivery and pace
The course is delivered online to accommodate busy working professionals. Content is released in phases over eight weeks, allowing participants to progress together as a cohesive cohort. This phased structure supports sustained engagement and meaningful interaction on discussion boards, which are integral to achieving course outcomes.
Learning experience and assessment
- A blended learning approach combines text-based materials with interactive activities to foster practical understanding of international standards, including ICH GCP.
- Formative, self-assessment through multiple-choice questions allows participants to monitor their progress as they advance.
- Embedded videos illustrate real-world applications, demonstrating how clinical research professionals navigate common challenges.
- Discussion boards form the core of the learning experience. Participants reflect on course material, respond to prompts, and engage with peers and academics. All responses are publicly visible after submission, encouraging transparency and reflective dialogue.
- Academics monitor discussions and provide timely guidance and expert feedback to deepen understanding and support achievement of course outcomes.
Key learning outcomes
By the end of the microcredential, participants will be able to:
- Identify the importance, management, and necessary documents to run a clinical trial.
- Describe the ethical principles and processes required to ensure informed consent.
- Apply monitoring, reporting, and auditing principles to ensure study outcomes support decision-making.
- Apply the National Statement to ensure research proposals meet national requirements.
- Apply the principles of GCP to the conduct of a clinical trial.
Who should enrol?
This program is designed for clinical, pharmaceutical, and medical device research professionals seeking foundational, globally aligned knowledge to support compliant, ethical, and practical research practices. Delivered through an online, phased cohort model, it offers a flexible yet rigorous introduction to essential clinical research competencies. Ideal for professionals around the world balancing work and study.
Why choose this microcredential?
- Internationally recognised standard in clinical research practice.
- Strong collaboration with PRAXIS Australia and the University of Sydney in governance and delivery, ensuring rigorous, practically relevant content.
- Flexible online delivery with a phased cohort that fosters rich discussion and sustained engagement.
- Focused on practical application: implementing ethics, consent, monitoring, reporting, and governance in real-world trials.
Our collaboration with PRAXIS Australia and the University of Sydney underscores a strong commitment to quality and industry relevance. The program imparts theoretical knowledge while developing the practical judgment required to navigate complex regulatory environments and operational challenges in clinical research. Whether you are advancing within a current role or preparing for broader responsibilities, this microcredential provides a solid, internationally aligned foundation to support compliant, ethical, and efficient clinical trial practice.
Examples provided in the Clinical Trials Fundamentals microcredential will reflect Australian standards of clinical trial conduct, regulations, competent authorities, and national and state/territory compliance requirements. Core principles, including ICH-GCP, are internationally recognised, ensuring the program is suitable for participants worldwide.
Topics
What you’ll study:
Core Modules (all participants complete)
- Essential Documentation in Clinical Trials
- Introduction to Ethics
- Consent to Research
- Research Monitoring and Audit
- Safety Monitoring and Reporting in Clinical Trials
- The National Statement
- Principles of Good Clinical Practice (GCP)
Elective Modules (Choose two)
- Ethics in Clinical Trials – research design and conduct
- Data in Research
- Data Management – Privacy, Security, and Governance Across the Lifecycle
Learning Outcomes
- Identify the importance, management, and necessary documents to run a clinical trial
- Describe the ethical principles and processes required to ensure informed consent
- Apply monitoring, reporting, and auditing principles to ensure study outcomes/endpoints support decisions
- Apply the National Statement to ensure research proposals meet the National Requirements
- Apply the principles of GCP to the conduct of a clinical trial
Course delivery method
Exam dates:
Core modules - multiple choice question exam and short answer exam: Thursday 29 October 10:00 - 14:00 AEDT
Elective modules (2 modules) - 1 short answer exam per module: Thursday 5 November 10:00 - 14:00 AEDT
Additional Information
While not mandatory, it is recommended that you review the most recent version of the ICH-GCP guidelines before starting the course to support your learning.
Credit Towards Award Courses
This microcredential provides 2 credit points towards selected University of Sydney programs in Pharmaceutical and Medical Device Development, including Graduate Diplomas and Masters degrees. Completing both microcredentials typically gives 4 credit points, and additional credit may be granted for relevant work experience.
Microcredential and Digital Badge
On completion, participants receive:
- A University-recognised Microcredential.
- A Digital Badge, a secure credential that verifies learning outcomes and can be shared on platforms like LinkedIn.
In partnership with PRAXIS Australia
For terms and conditions, please view here.