REF. CL04 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
Clinical development and post-market clinical follow-up of a Medical Device may include clinical investigations or studies to collect data on the product. These clinical investigations and post-market studies must be conducted in accordance with the Good Clinical Practices set out in ISO 14155, which ensures ethical and scientific quality.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Become familiar with Good Clinical Practices according to ISO 14155
TARGET TRAINEES
- Medical Device manufacturers
- Medical Device development or market operators
- Interested parties (auditors, evaluators, etc.)
PREREQUISITES
No prior knowledge required
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Work is based on applicable regulations and standards
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Good Clinical Practices: context and definitions
- Background and definitions
- Regulatory requirements (a review)
- Presentation of ISO 14155:2020
- Ethical considerations
- Roles and responsibilities
- Good Clinical Practices: application
- Essential study documents
- Major study stages
- Collection of study data
- Quality Assurance, Quality Control 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%).
