ISO GCP (ISO 14155) Refresher Training for Clinical Investigations with Medical Devices – webinar
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About this course
Reasons to attend
As a monitor, project manager, or member of an investigator team, it is important to stay current on the ISO 14155 Good Clinical Practice standard for clinical investigations involving medical devices and human subjects. This 2-hour course will help refresh and update your knowledge of ISO-GCP, specifically the 2020 version, and provide guidance on how to comply with the standard in your clinical research activities.Course Description
This 2-hour course on ISO-GCP is designed for professionals in the clinical research field, such as project managers, CRAs, medical monitors, field engineers, study coordinators, study nurses, and investigator teams, who need to refresh their knowledge of the latest ISO-GCP standard for conducting and documenting clinical studies with medical devices. The training covers all sections of the standard, including the distinct responsibilities of sponsors and investigators, and requirements for oversight and risk-based management. Real-life case studies and interactive polls are included to reinforce understanding and awareness of key concepts and essential documents. The course also covers FDA observations on deviations that are considered violations and the use of digital tools, such as electronic informed consent, while maintaining GCP compliance. Common questions from practice are also answered to provide a comprehensive understanding of the rules and responsibilities outlined in the ISO-GCP standard. The training concludes with a final quiz, reviewing the key topics covered throughout the session.Programme highlight
- Fundamentals of ethics and regulatory compliance in ISO-GCP, including updates in the 2020 version.
- Hands-on review of the 13 core principles of ISO-GCP.
- Examination of the roles and responsibilities of medical device study stakeholders, including the ethics committee, sponsor, and investigator.
- Implementation of a risk-based approach to quality management and monitoring in practice.
- Discussion of the relationship between ISO-GCP and the ISO 14971 standard for evaluating medical device risks.
- Strategies for demonstrating study oversight by the sponsor and investigator.
- Preparation for audits, including examples of FDA findings at sponsor and investigation sites.
- Q&A session, and coverage of electronic informed consent and decentralized clinical studies.
Learning objectives
- Acquire in-depth understanding of ISO-GCP principles and roles of all clinical study stakeholders.
- Enhance ability to monitor and control clinical trials for medical devices.
- Familiarize oneself with the required clinical study tasks and associated study documents in accordance with ISO-GCP.
- Understand the risk-based approach for quality management and how to handle risks at different levels.
- Develop skills to apply risk-based monitoring as part of the monitoring plan.
- Recognize the significance of safety reporting and the thorough evaluation of serious safety events of medical devices during and before the clinical study.
- Learn about the necessary documents required for oversight.
- Acquire knowledge of exemptions applicable to post-market clinical studies.
- Gain insight into ISO-GCP requirements when using digital tools.
Who should attend
Project Managers, CRAs, medical monitors, study coordinators, study nurses and investigators working on clinical investigations with medical devices.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen () Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Trainers
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