Clueo Clinical

Masterclass: Drug Safety Monitoring and Regulatory Reporting Requirements in Australia
2026-03-27 15:00 - 17:00 (Australia/Melbourne)
Register

Are you an aspiring or early-career clinical research professional wanting to enhance your industry skills to enhance your CV and job-readiness? In the dynamic clinical trial industry, ensuring patient safety is paramount, particularly within Australia’s stringent regulatory framework.

This 2-hour interactive masterclass offers an in-depth exploration of Drug Safety Monitoring and Regulatory Reporting Requirements in Australia, providing practical strategies to tackle real-world challenges head-on. Equip yourself with the knowledge and skills to navigate the complex landscape of pharmacovigilance effectively, improve compliance, and uphold the highest standards of clinical research.

Key Benefits:

🔹 Regulatory Compliance: Align your practices with Australian regulatory requirements to ensure compliance and avoid potential legal issues.

🔹 Enhanced Safety Monitoring: Implement robust safety monitoring processes to protect trial participants and ensure data integrity.

🔹 Effective Reporting: Master the procedures for timely and accurate adverse event reporting, contributing to the overall safety profile of investigational products.

🔹 Risk Mitigation: Develop and apply risk management strategies to proactively identify and address potential safety concerns during clinical trials.

🔹 Professional Development: Enhance your expertise in pharmacovigilance, boosting your CV and increasing your job readiness in the competitive field of clinical research.

What You’ll Learn:

✅ Australian Regulatory Framework: Gain a comprehensive understanding of the Therapeutic Goods Administration’s (TGA) pharmacovigilance responsibilities for medicine sponsors, including mandatory reporting requirements and best practices.

✅ Safety Monitoring in Clinical Trials: Learn the procedures and requirements related to safety data collection, verification, and reporting in clinical trials, as outlined by the National Health and Medical Research Council (NHMRC).

✅ Adverse Event Reporting: Understand the importance of reporting adverse drug reactions (ADRs) and how such reports contribute to medicine and vaccine safety in Australia.

✅ Risk Management Strategies: Develop effective risk management plans to identify, assess, and mitigate potential safety issues during clinical trials.

✅ Compliance with Good Clinical Practice (GCP): Ensure adherence to GCP guidelines for safety monitoring and reporting, maintaining the highest ethical and scientific standards in clinical research.

Who Should Attend?

🔹 Aspiring Clinical Research Associates (CRAs)

🔹 Clinical Trial Assistants (CTAs)

🔹 Research Nurses & Study Coordinators

🔹 University Graduates & Career Changers in Clinical Research

🔹 Anyone looking to strengthen their industry communication skills

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!

Masterclass: Performing Source Document Verification (SDV) and Risk-Based Monitoring
2026-03-20 15:00 - 17:00
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Are you an aspiring or early-career clinical research professional wanting to enhance your industry skills to enhance your CV and job-readiness? Are you an aspiring or early-career clinical research professional aiming to enhance your CV and job readiness? Mastering Source Document Verification (SDV) and conducting effective On-Site Monitoring are critical skills for a successful Clinical Research Associate (CRA).

Our 2-hour interactive masterclass is designed to equip you with the industry’s best practices, expert knowledge and practical skills needed to excel as a CRA, ensuring data integrity and regulatory compliance in clinical trials.

Key Benefits of Attending:

🔹 Enhanced Monitoring Competence: Develop the skills necessary to perform thorough SDV and effective on-site monitoring, ensuring high-quality clinical trial data.

🔹 Improved Regulatory Compliance: Learn to navigate complex regulatory requirements, reducing the risk of non-compliance during clinical trials.

🔹 Career Advancement: Strengthen your CV with specialised training, increasing your competitiveness in the clinical research job market.

🔹 Practical Application: Engage in interactive sessions that provide hands-on experience with real-world scenarios, preparing you for challenges encountered in the field.

🔹 Enhanced Monitoring Efficiency: Develop the ability to conduct effective remote monitoring, reducing the need for frequent on-site visits while maintaining data quality.

🔹 Improved Risk Management: Implement RBM strategies to proactively identify and mitigate potential issues in clinical trials.

🔹 Regulatory Adherence: Ensure compliance with current regulatory standards for monitoring, minimizing the risk of non-compliance.

🔹 Professional Development: Expand your skill set with contemporary monitoring techniques, increasing your value in the clinical research field.

What You’ll Learn:

✅ Fundamentals of Source Document Verification (SDV): Understand the process of comparing case report form data against original source documents to ensure accuracy and completeness.

✅ Effective On-Site Monitoring Techniques: Learn how to conduct various types of site visits, including qualification, initiation, routine, and close-out visits, to ensure compliance with study protocols and regulatory requirements.

✅ Regulatory Compliance and Good Clinical Practice (GCP): Gain insights into adhering to GCP guidelines and maintaining ethical standards during clinical trial monitoring.

✅ Data Integrity and Quality Assurance: Develop skills to ensure the accuracy, consistency, and reliability of clinical trial data through meticulous monitoring practices.

✅ Foundations of Remote Monitoring: Understand the principles and benefits of remote monitoring, including strategies for data review, query management, and identifying site compliance issues without physical visits.

✅ Risk-Based Monitoring (RBM) Strategies: Explore the core concepts of RBM, focusing on prioritizing monitoring activities based on risk assessment to enhance efficiency and resource allocation.

✅ Regulatory Guidelines and Compliance: Gain insights into the regulatory frameworks governing remote and risk-based monitoring, ensuring adherence to Good Clinical Practice (GCP) and other relevant guidelines.

✅ Data Management and Centralised Monitoring: Learn how to utilize centralized data aggregation and statistical monitoring techniques to oversee trial progress and maintain data quality.

✅ Practical Application and Case Studies: Engage with real-world scenarios to apply remote and RBM methodologies, enhancing problem-solving skills and decision-making in clinical trial monitoring.

Who Should Attend?

This masterclass is ideal for:

🔹 Aspiring Clinical Research Associates: Individuals seeking to enter the field of clinical research and develop foundational monitoring skills.

🔹 Early-Career CRAs: Professionals aiming to enhance their proficiency in SDV and on-site monitoring to advance their careers.

🔹 Clinical Trial Coordinators and Managers: Personnel involved in overseeing clinical trial operations who wish to deepen their understanding of monitoring processes.

🔹 Quality Assurance Specialists: Individuals responsible for ensuring compliance and data integrity in clinical research settings.

By participating in this masterclass, you’ll gain practical insights and tools to excel in Source Document Verification (SDV) and On-Site Monitoring as a Clinical Research Associate (CRA), ensuring the highest standards of data integrity and regulatory compliance in your clinical trials.

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!

Masterclass: Ensuring Drug Accountability in Clinical Trials
2026-03-13 15:00 - 17:00
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Maintain Compliance and Data Integrity Through Effective Drug Management

In clinical trials, drug accountability is crucial for ensuring participant safety, maintaining data integrity, and complying with regulatory standards. Proper management of investigational products (IPs) involves meticulous tracking of their receipt, storage, dispensing, and disposal. Regulatory agencies, including the TGA (Australia) and FDA (USA), emphasise the importance of accurate drug accountability records, as deficiencies can lead to significant compliance issues.

This 2-hour interactive masterclass offers a comprehensive guide to implementing robust drug accountability practices, ensuring your clinical trials adhere to Good Clinical Practice (GCP) guidelines and withstand regulatory scrutiny.

Key Benefits of Attending:

🔹 Ensure Compliance: Align your drug accountability practices with global regulatory standards to avoid common compliance issues.

🔹 Protect Data Integrity: Maintain accurate records to ensure the reliability of trial results.

🔹 Enhance Participant Safety: Implement procedures that ensure participants receive the correct IP dosages.

🔹 Improve Audit Outcomes: Be prepared for inspections with comprehensive and accurate drug accountability documentation.

🔹 Gain Practical Insights: Learn from real-world scenarios to apply best practices in your trials.

What You’ll Learn:

✅ Regulatory Requirements: Understand the specific drug accountability obligations under ICH-GCP and TGA and FDA regulations.

✅ Comprehensive Record-Keeping: Learn to maintain detailed records of IP receipt, storage conditions, dispensing logs, returns, and disposal methods.

✅ Risk Mitigation Strategies: Identify common pitfalls in drug management and develop strategies to prevent non-compliance.

✅ Inventory Management: Master techniques for accurate tracking and reconciliation of IP inventory throughout the trial lifecycle.

✅ Audit Preparedness: Prepare for regulatory inspections by ensuring your drug accountability processes are thorough and transparent.

Who Should Attend

This masterclass is designed for:

🔹 Aspiring / Clinical Research Associates (CRAs): Enhance your oversight of site-level drug management.

🔹 Clinical Trial Coordinators (CTCs): Implement effective drug accountability procedures at trial sites.

🔹 Pharmacists and Pharmacy Technicians: Ensure proper handling and documentation of investigational products.

🔹 Regulatory Affairs Professionals: Align drug accountability practices with current regulatory expectations.

🔹 Quality Assurance Personnel: Monitor and audit drug management processes to uphold trial integrity.

🔹 University Graduates & Career Changers in Clinical Research

🔹 Anyone looking to strengthen their industry skills

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!

Masterclass: Reviewing Informed Consent Forms (ICFs) for Compliance and Ethical Considerations
2026-03-06 15:00 - 17:00
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Informed Consent is the cornerstone of ethical clinical research, ensuring that participants fully understand their rights, risks, and study procedures before enrolling in a trial. Regulatory agencies such as the FDA and TGA require strict adherence to Good Clinical Practice (GCP) guidelines to protect patient autonomy and data integrity.

This 2-hour interactive masterclass provides a step-by-step approach to reviewing Informed Consent Forms (ICFs) for compliance, ethical considerations, and regulatory approval. Participants will learn how to identify common deficiencies, apply best practices, and ensure alignment with international regulations to safeguard both patients and trial integrity.

Key Benefits of Attending

✔ Master ICF Compliance – Learn TGA, FDA and ICH-GCP requirements for Informed Consent.

✔ Ensure Ethical Integrity – Protect participant rights by ensuring clarity, transparency, and voluntariness in ICFs.

✔ Identify & Correct Common Deficiencies – Spot missing elements, ambiguous language, and regulatory gaps.

✔ Strengthen Regulatory Submission Success – Align ICFs with ethics committee and regulatory body expectations.

✔ Improve Stakeholder Communication – Ensure sponsors, CROs, and investigators maintain ICF consistency and compliance.

✔ Learn from Real-World Case Studies – Apply practical strategies from actual ICF review challenges.

What You’ll Learn:

✅ Key regulatory requirements for ICFs under ICH-GCP, FDA, and TGA

✅ Ethical principles of informed consent, including patient rights and autonomy

✅ Common compliance pitfalls and how to prevent regulatory findings

✅ How to assess readability and clarity to ensure participant understanding

✅ Best practices for ethics submissions and approval

✅ How to conduct an effective ICF review using real-world case studies

Who Should Attend?

🔹 Aspiring / Clinical Research Associates (CRAs)

🔹 Clinical Trial Coordinators (CTCs)🔹 Clinical Investigators & Site Staff🔹 Regulatory Affairs & Quality Assurance Professionals🔹 Ethics Committee Members & IRB/IEC Representatives🔹 Sponsors & CRO Teams🔹 Anyone involved in clinical trial compliance & patient consent processes

🔹 University Graduates & Career Changers in Clinical Research🔹 Anyone looking to strengthen their industry skills

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!

Masterclass: Best Practices for TMF Filing and Maintenance Throughout Clinical Trials
2026-02-27 15:00 - 17:00
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Proper management of the Trial Master File (TMF) is essential for ensuring regulatory compliance, maintaining data integrity, and supporting the success of clinical trials. A well-maintained TMF not only facilitates smoother audits and inspections but also demonstrates the trial’s adherence to Good Clinical Practice (GCP) and regulatory requirements.

Are you an aspiring or early-career clinical research professional looking to strengthen your TMF filing and maintenance skills? Managing essential trial documentation effectively is a critical skill for Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), Study Coordinators, and other research professionals.

This interactive 2-hour masterclass will provide you with practical strategies to improve your TMF documentation processes and ensure your files are always audit- and inspection-ready. Learn how to maintain document integrity, apply best practices for version control, conduct quality control (QC) checks, and meet regulatory expectations to prevent findings during audits.

Key Benefits:

🔹 Ensure Compliance & Inspection Readiness – Learn how to maintain a complete and accurate TMF to meet regulatory and sponsor requirements.🔹 Reduce Audit Risks – Identify common TMF deficiencies and implement corrective actions to improve documentation quality.🔹 Enhance Your Career Prospects – Gain expertise in TMF management, a crucial skill valued by sponsors, CROs, and regulatory agencies.🔹 Hands-on Learning with Industry Experts – Access real-world case studies and actionable insights from experienced professionals.

What You’ll Learn:

✅ Understanding TMF Structure & Regulatory Expectations – Learn about essential documents and global regulatory requirements (ICH-GCP, EMA, FDA).✅ Best Practices for TMF Filing & Maintenance – Organise, categorise, and maintain TMF documentation efficiently.✅ Document Version Control & QC Checks – Implement processes to track changes, prevent errors, and maintain data integrity.✅ Strategies for Ensuring Inspection Readiness – Proactively identify and resolve TMF gaps before audits and inspections.

Who Should Attend?

🔹 Aspiring Clinical Research Associates (CRAs)🔹 Clinical Trial Assistants (CTAs)🔹 Research Nurses & Study Coordinators🔹 University Graduates & Career Changers in Clinical Research🔹 Anyone looking to strengthen their industry communication skills

📍 Format: Live Virtual Masterclass. This online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee will receive a certificate of completion to boost your CV and enhance your employability.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBPTM), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided during registering.

✨ Early Bird Discount: Save 20%✨ Group Discount: Enrol with 2 or more colleagues and save 30%!

📢 Referral Bonus!

Share this event with your network! For every friend or colleague you refer who registers, you’ll receive an addition 10% discount on your own ticket! Plus, the person you refer will get a 10% special discount too!

Masterclass: Preparing for Audits and Regulatory Inspections in Clinical Trials
2026-02-24 15:00 - 17:00
Register

In the highly regulated clinical research industry, compliance with Good Clinical Practice (GCP) and regulatory requirements is non-negotiable. Regulatory agencies such as the FDA (United States), and TGA (Australia) conduct inspections to ensure that clinical trials meet the highest standards of data integrity, patient safety, and ethical conduct. In addition, sponsors and Contract Research Organisations (CROs) frequently audit trial sites to assess compliance with protocol requirements, GCP guidelines, and applicable regulations.

Failing an audit or inspection can result in serious consequences, including trial delays, regulatory sanctions, financial penalties, and reputational damage. Therefore, being inspection-ready at all times is essential for clinical research professionals involved in trial management, monitoring, and site operations.

This 2-hour interactive masterclass provides a structured, step-by-step approach to preparing for regulatory inspections and audits. Attendees will gain insider knowledge, proven strategies, and real-world case studies to navigate inspections confidently, minimise compliance risks, and implement proactive quality assurance practices.

Key Benefits:

🔹 Understand Global Regulatory Expectations – Learn TGA, FDA and inspection requirements and common audit findings.

🔹 Achieve Audit Readiness – Develop proactive strategies to ensure continuous compliance and prepare teams effectively.

🔹 Minimize Compliance Risks – Identify gaps early, implement CAPA strategies, and avoid critical findings.

🔹 Confidently Handle Inspections – Master best practices for interviews, document requests, and regulatory responses.

🔹 Learn from Real-World Cases – Gain insights from actual audit scenarios and interactive expert discussions.

🔹 Strengthen Collaboration – Improve compliance alignment across sites, sponsors, and CROs.

What You’ll Learn:

✅ Understanding ICH-GCP, FDA, EMA, and TGA inspection requirements

✅Common audit findings and how to prevent them

✅Best practices for site, sponsor, and CRO audit readiness

✅ Effective CAPA (Corrective and Preventive Actions) planning

✅How to handle inspection interviews and document requests

✅Real-world case studies of regulatory compliance challenges

Who Should Attend?

🔹 All Aspiring Clinical Researchers

🔹 Clinical Research Associates (CRAs)

🔹 Clinical Trial Assistants (CTAs)

🔹 Regulatory Affairs & Quality Assurance Professionals

🔹 Sponsors & CRO Teams

🔹 Anyone involved in clinical trial compliance & oversight

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!

Masterclass: Effective Communication Strategies for Stakeholder Management in Clinical Research
2026-02-14 15:00 - 17:00
Register

Are you an aspiring or early-career clinical research professional looking to improve your communication skills with stakeholders to achieve better compliance? Effective communication is a game-changer for achieving better compliance and success in clinical trials. This interactive 2-hour masterclass will equip you with practical strategies to improve collaboration, build trust, and manage complex conversations with sponsors, ethics committees, investigators, and site teams.

Key Benefits:

🔹 Boost Confidence: Master essential communication techniques to enhance your ability to engage with key stakeholders.🔹 Foster Collaboration: Learn how to create stronger connections and improve teamwork across all levels of the clinical trial process.🔹 Navigate Challenges: Gain strategies to handle difficult conversations and resolve conflicts with sponsors, CROs, and site staff.🔹 Achieve Better Compliance: Sharpen your communication skills to ensure clearer documentation, reporting, and decision-making, driving compliance and successful trial outcomes.🔹 Learn from Experts: Benefit from real-world case studies and actionable insights shared by clinical research professionals

What You’ll Learn:

✅ How to communicate effectively with sponsors, CROs, and site staff✅ How to navigate complex conversations with sponsors, ethics committees, and investigators✅ Best practices for conflict resolution and handling difficult conversations✅ Strategies to improve team collaboration and cross-functional communication✅ Real-world case studies and actionable insights from clinical research experts

Who Should Attend?

🔹 Aspiring Clinical Research Associates (CRAs)🔹 Clinical Trial Assistants (CTAs)🔹 Research Nurses & Study Coordinators🔹 University Graduates & Career Changers in Clinical Research🔹 Anyone looking to strengthen their industry communication skills

📍 Format: Live Virtual Masterclass. This online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee will receive a certificate of completion to boost your CV and enhance your employability.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided during registering.

✨ Early Bird Discount: Save 20%✨ Group Discount: Enrol with 2 or more colleagues and save 30%!
