REF. CL05 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of a Medical Device’s compliance with the General Safety and Performance Requirements (GSPR) may include a clinical investigation according to Regulation (EU) 2017/745. The goal of this clinical investigation is to collect safety and performance data specific to the device. It must be planned, designed and conducted according to the regulatory and ethical recommendations in effect.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Understand the regulatory ((EU) 2017/745), legal and ethical requirements for clinical investigations
- Become familiar with the essential documents and steps to take to conduct an investigation
TARGET TRAINEES
- Medical Device manufacturers
- Medical Device development or market operators
PREREQUISITES
No prior knowledge required
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Work is based on applicable regulations and standards
- Distribution of the information presented
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Clinical investigations: context and definitions
- Introduction to clinical research
- Regulatory and legal context
- The different types of studies
- Roles and responsibilities
- Investigation design
- Essential documents and their use
- Essential study documents
- Submission of the investigation
- Major study stages
- Conduct of the investigation
- Good Clinical Practices and Vigilance
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 80%).
