You are a monitor, a project manager or part of an investigator team and need to understand the counterpart of ICH-GCP for medical device trials. You want to know the rules and responsibilities outlined in ISO14155 and get some practical advice and tips on improving your medical device monitoring skills? This course is made for you and your colleagues!
This one day course brings CRAs and Investigators up to speed with the ISO14155, when working with device clinical trials. This standard is mandatory in Pre-Marketing studies but is very frequently followed in the Post-Marketing release study environment, especially when the results of these trials are to be published in major medical journals. Although up to a certain level comparable with ICH-GCP, the ISO14155 standard features a series of requirements and terminologies that are very specific to medical devices. This course will guide the trainees through all the sections of this document.
A quiz, covering the most important items will end the training day, offering the trainees a brief rehearsal on what has been discussed during the training.
Course time09h00 - 17h00
Who should attend
Project Managers, CRAs, study co-ordinators or Investigators working on Clinical Investigation with Medical Devices.
- Focus on the overall content and structure of the ISO14155 standard
- In depth review of responsibilities of each of the medical device stakeholders
- Practical implementation of the standard
- To understand the role of clinical studies in the development of devices
- To be familiar with the basic requirements on how clinical trials are carried out
- To appreciate the device-specific study elements as compared to drugs studies
- To familiarise the participants with expected clinical tasks
This course covers competencies that are part of the ECCRT Competency Framework:
- Ethical & Participants Safety Considerations (4)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Data Management and Informatics (4)
- Leadership and Professionalism (1)