REF. CL06 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of a Medical Device’s compliance with the General Safety and Performance Requirements may include a clinical investigation. The goal of this clinical investigation is to collect safety and performance data specific to the device. A clinical investigation must be conducted in accordance with Good Clinical Practices, which ensure ethical and scientific quality.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Identify the regulatory stages and obligations for an investigation
- Understand the requirements for a clinical investigation in order to comply with Regulation (EU) 2017/745, the legal obligations in effect, and Good Clinical Practices according to ISO 14155:2020
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 investigation: context and definitions
- Terms and definitions
- Regulatory (Regulation (EU) 2017/745) and legal framework
- The different types of studies
- The different parties and their responsibilities
- Investigation design
- Clinical investigation: essential documents
- Study documents
- Submission and evaluation of the investigation
- Major study stages
- GCP: context and application
- ISO 14155
- Ethical considerations
- Quality Assurance and Control
- 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%).
