ISO 14155 Good Clinical Practice Training – eLearning
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| ISO 14155 Good Clinical Practice Training - eLearning | Online | EUR 500 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
You are a monitor; a project manager or part of an investigator team and you need to understand the counterpart of ICH-GCP for medical device trials. You want to know the rules and responsibilities outlined in the ISO-GCP standard, ISO 14155 version of 2020, and get some practical advice and tips?This ISO 14155 Good Clinical Practice Training is made for you and your colleagues!What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Course credit: 4h
- Complete the course at anytime, anywhere!
Course Description
This course brings Sponsors, CRAs and Investigators up to speed with the ins and outs of the ISO 14155:2020, when working with device clinical trials. This standard is mandatory in Pre-Marketing studies and is very frequently followed in the post-Market 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 to ICH-GCP, the ISO-GCP 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 standard. Cases are included in to clarify the GCP-requirements “in practice”. 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.Programme highlight
- Focus on the overall content and structure of the ISO-GCP standard
- In depth review of responsibilities of each of the medical device stakeholders
- Practical implementation of the standard concerning planning, conduct and documentation
- Guidance to prepare for audits and examples of audit findings
Learning objectives
- Understand the role of clinical studies in the development of devices
- Comprehend the settings of the ISO-GCP 14155 standard
- Grasp key principles and basic requirements on how clinical trials with medical devices are to be carried out
- Understand the risk-based approach of monitoring and of quality management of clinical trials
- Be familiar with expected clinical study tasks and associated study documents
- Improve your monitoring and management skills in line with ISO-GCP
- Appreciate the device-specific study- and GCP- elements as compared to drug studies
Who should attend
Project Managers, CRAs, medical monitors, field engineers, study co-ordinators or 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 (0)
- Ethical & Participants Safety Considerations (4)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (0)
- Data Management and Informatics (4)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
No trainer yet
Gert Everaert
Janssen