High-quality clinical research, adequate reporting, and strict adherence to quality requirements are crucial for obtaining market entry approval for new medical technology. After completing the Good Clinical Practice (GCP) and ISO 14155 course, you will be able to design and conduct clinical patient-related research according to national and international regulations.
- Gain insights into all quality requirements according to ISO 14155 and GCP
- Learn methods for designing and conducting clinical research
- Work on research documentation and effective reporting
About the Good Clinical Practice (GCP) and ISO 14155 course
The quality of clinical research and the accurate reporting of conclusions are crucial for obtaining market entry approval from Notified Bodies for new medical technologies. Therefore, it is important to adhere strictly to quality standards such as ISO 14155 and Good Clinical Practice (GCP). The Good Clinical Practice and ISO 14155 course focuses on the guidelines for conducting clinical patient-related research.
During this ISO 14155 course, you will learn how to design and conduct clinical patient-related research according to national and international regulations. The course also emphasizes general requirements for study subjects, proper reporting practices, and the responsibilities of all parties involved.
Program
ISO 14155 / Good Clinical Practice
- The four phases of clinical research
- Requirements for Good Clinical Practices (GCP) and its principles
- Role and responsibility of investigators, study staff, and stakeholders
Introduction to clinical studies
- Definition of clinical studies and their purpose
- Types of clinical studies
- Pre-market versus post-market clinical studies
Protection of study subjects
- Declaration of Helsinki and Dutch legislation
- Informed consent process
- Ethical considerations
Medical Ethical Review Committee (METC)
- Purpose and function
- Organizational structure
- Responsibilities and reporting
Responsibilities of sponsor and investigator
Contact us for more information
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Our training manager is happy to think along with you!
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.