You have clinical research experience in general, but somehow running clinical trials with medical devices still has some secrets for you? This course will provide you with a very practical set of information, tools and knowledge which will ultimately increase your competency level for running medical device trials. This 2-day course is also the core of our Medical Device STAR Programme.
This 2-day course is focussing on the different phases of Medical Device Clinical Research, the life cycle of device development, ISO14155 and the role of each team member (Sponsor (CRA, PM) and Site (Investigator, Study Coordinator). These 2 days are specifically designed for people with a strong interest in Medical Devices, with or without a long track record.
In addition to theory, interactive workshops will introduce the participants to the operations of Medical Device Clinical Research from each of their positions and roles. It will highlight how things are different compared to trials with medicinal products. The workshops will be organised as breakout groups to allow approaching the various topics from the different positions involved.
Course time09h00 - 17h00
Who should attend
Everyone starting to be involved in running clinical research with medical devices, both from the sponsors perspective as well as from the investigational site perspective.
At least 1-year experience in clinical trial is required.
- The life cycle of medical device development
- Study design challenges in Medical Device development
- The role of the team involved in clinical trials with medical devices
- Differences between drug and device clinical trials from an operational point of view
- Understand the life cycle of medical device development and the challenges in study design
- Understand how to run clinical trials with medical devices from an operational perspective
- Recognize operational differences between trials with drugs and device
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (9)
- Study and Site Management (7)
- Data Management and Informatics (2)
- Leadership and Professionalism (4)
- Communication (4)
- Teamwork (2)
- Business acumen (0)
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