Self Paced - On Demand Learning

GCP Training for Investigational Sites and Sponsor Representatives E6 (R3)

This self-paced online training is designed for all clinical research stakeholders—investigators, study coordinators, and sponsor representatives—and meets the ICH-GCP E6(R3) requirements recognised by TransCelerate BioPharma.

Structured into three modules, the program provides a comprehensive overview of Good Clinical Practice from multiple perspectives. Participants will explore the clinical trial process, regulatory and ethical responsibilities, adverse event reporting, documentation standards, and key roles including sponsors, investigators, and ethics committees.

Each module includes interactive content, real-world case studies, and assessments to support application of learning. The course is based on current Australian and international guidelines, including:

• ICH-GCP (E6 R3)
• The National Statement on Ethical Conduct in Human Research
• The Australian Clinical Trial Handbook

You will learn to:

• Understand GCP principles across the trial lifecycle
• Navigate the roles and obligations of sponsors, sites, and ethics committees
• Apply ethical and quality management principles in clinical research
• Prepare for audits, manage documentation, and ensure trial compliance

A certificate of completion is awarded at the end of the 3 modules, with full CPD eligibility for LifeSciences Australia members. Accessible 24/7, this asynchronous eLearning format allows completion at your own pace within a three-month timeframe.

Applied GCP Training for Investigational Sites and Sponsor Representatives E6 (R2) Certificates 1, 2 & 3

This self-paced online training is designed for all clinical research stakeholders—investigators, study coordinators, and sponsor representatives—and meets the ICH-GCP E6(R2) requirements recognised by TransCelerate BioPharma.

Structured into three certificates, the program provides a comprehensive overview of Good Clinical Practice from multiple perspectives. Participants will explore the clinical trial process, regulatory and ethical responsibilities, adverse event reporting, documentation standards, and key roles including sponsors, investigators, and ethics committees.

Each module includes interactive content, real-world case studies, and assessments to support application of learning. The course is based on current Australian and international guidelines, including:

• ICH-GCP (E6 R2)
• The National Statement on Ethical Conduct in Human Research
• The Australian Clinical Trial Handbook

You will learn to:

• Understand GCP principles across the trial lifecycle
• Navigate the roles and obligations of sponsors, sites, and ethics committees
• Apply ethical and quality management principles in clinical research
• Prepare for audits, manage documentation, and ensure trial compliance

A certificate of completion is awarded for each of the three components, with full CPD eligibility for LifeSciences Australia members. Accessible 24/7, this asynchronous eLearning format allows completion at your own pace within a one-month timeframe.

LifeSciences Australia Refresher GCP Training E6(R2)

This self-paced online course is designed for clinical research professionals who have previously completed GCP training and need to refresh their knowledge in line with ICH E6(R2).

Covering key updates and Australian-specific requirements, the course reinforces core principles of Good Clinical Practice, including safety reporting, documentation, and stakeholder responsibilities.

Based on current national and international guidelines, it ensures continued compliance and readiness for clinical trial conduct. A certificate of completion is provided, and CPD tracking is available for LifeSciences Australia members.

Complete at your own pace within one month.

LifeSciences Australia ISO 14155 (2020) Training

This self-paced online course provides a comprehensive introduction to ISO 14155:2020 – the international standard for Good Clinical Practice (GCP) in clinical investigations of medical devices for human subjects.

Designed for clinical researchers, sponsor representatives, and regulatory professionals working with medical devices, this module explores the ethical and scientific quality standards required for designing, conducting, recording, and reporting clinical investigations involving medical devices.

Participants will gain an understanding of how ISO 14155 aligns with ICH GCP, the roles and responsibilities of key stakeholders, risk management principles, informed consent processes, and requirements for data integrity and monitoring. The course also outlines the key changes introduced in the 2020 revision of the standard and how they impact clinical trial operations.

By the end of the course, learners will be able to:

• Understand the structure and scope of ISO 14155:2020
• Apply core GCP principles to medical device trials
• Identify the responsibilities of investigators and sponsors under the standard
• Recognise documentation, safety reporting, and monitoring requirements unique to device trials
• Interpret the 2020 updates and their implications for trial conduct and compliance

This course is ideal for professionals new to device clinical trials, or those seeking a refresher on ISO 14155:2020. A certificate of completion is provided upon successful completion, and CPD tracking is available via the LifeSciences Australia member portal.

Overview of the MTP Sector Training

This self-paced online course introduces the structure, stakeholders, and pathways that define Australia's Medtech, Biotech and Pharmaceutical (MTP) sector. Designed for early-career professionals, students, and those new to the industry, the course provides essential context for anyone looking to understand how health technologies move from discovery to patient care.

Participants will explore the roles of sponsors, regulators, CROs, research sites, and support functions such as regulatory affairs, medical affairs, and pharmacovigilance. The course also outlines the product development lifecycle, clinical trial processes, and key Australian frameworks such as GCP, CTN/CTX, and ISO 14155.

You will learn to:

• Understand how the MTP ecosystem is structured in Australia
• Identify key roles across the clinical, regulatory, and commercial landscape
• Explain core regulatory and ethical principles guiding therapeutic development
• Recognise common industry terminology and acronyms

Ideal for those new to the sector or seeking a clearer understanding of how the industry operates, this course supports CPD and provides a certificate of completion.

Professional Foundations for Life Sciences

Professional Foundations for Life Sciences is a practical program designed to build the core capabilities needed to work effectively across the life sciences sector. Covering scientific research and design, responsible AI use, business concepts, leadership, collaboration, communication, effective meetings and decision-making, the program helps participants develop the professional skills and confidence to contribute in complex, cross-functional environments.

You will learn to:

• Explain key scientific, business and decision-making concepts that underpin effective work across the life sciences sector.
• Apply practical tools for responsible productivity, including the effective and ethical use of AI in professional settings.
• Use communication, collaboration and meeting skills to work more effectively with cross-functional teams and stakeholders.
• Demonstrate foundational leadership behaviours that support professionalism, accountability and continuous improvement.

Ideal for those new to the sector or seeking a clearer understanding of how the industry operates, this course supports CPD and provides a certificate of completion.

Patient Engagement eLearning Certificate Program

An ever-expanding area of collaboration is occurring among patients, patient organisations, industry, regulators, and governmental organisations to ensure that new drugs developed represent value to the patients they aim to treat, that patient access to innovations is accelerated, and that patient experience and outcomes are optimal.

Integrating the patient experience from the early stages of drug discovery and development through approval and post-marketing is now an accepted norm. However, for many companies, understanding why this is important as well as convincing leadership to invest in these activities can be confusing and elusive.

Learning objectives

• Introduction to Patient Engagement in Drug Development
  Upon completion of this module, learners should be able to: describe why integration of the patient perspective is integral for drug development programs; determine how other companies have executed and benefited from such programs; define what constitutes meaningful engagement from the patient point of view; and list steps a company can take to build a culture of patient engagement.
• Preparing for a Purposeful Patient Organisation Partnership
  Upon completion of this module, learners should be able to: recognise the rationale for partnering with patients; define different types of patient organisations and existing resources to identify the best fit; list factors to consider in timing the approach; and outline criteria for meaningful, quality engagements with patient organisations.
• Legal and Compliance Considerations for Engaging Patients as Partners
  Upon completion of this module, learners should be able to: identify the legal, ethical, and regulatory requirements for patient engagement; recognise standard contracting terms that can present challenges when engaging patient advocates; and outline appropriate compliance expectations for engaging patients and care partners.
• Creating a Patient-Focused Culture
  Upon completion of this module, learners should be able to: recognise the importance of patient-focused culture; describe approaches to assess current practices and attitudes from leadership and key functional areas; and identify change management strategies toward sustainable cultural change.
• Patient Engagement Evaluation and Metrics
  Upon completion of this module, learners should be able to: state the importance of evaluating patient engagement efforts; identify key principles of evaluation; discuss process, quality, outcomes, and return elements; and describe how to develop data sources for patient engagement evaluation.
• Developing a Comprehensive Patient Engagement Program
  Upon completion of this module, learners should be able to: determine the appropriate patient populations to engage; describe considerations for developing patient engagement goals aligned with the organisation's mission; and outline the structure of a patient engagement function that works across the full product lifecycle.

This program is designed for professionals involved in patient engagement, medical affairs, clinical research, regulatory affairs, pharmacovigilance, health outcomes, patient communications, and patient support. It is relevant to those working across patient advocacy, clinical trial design and operations, benefit-risk assessment, regulatory review, medical communications, medical science liaison roles, and patient advocacy organisations.