This suite of 3 courses provides a critical path for developing a clinical investigation plan for medical device human clinical research, both pre- and post market and based on worldwide regulatory requirements.
From a thorough review of the different sections of a clinical investigation plan including where to find the requirements in the regulations as explained in Course 1, to a systematic step-wise approach on how to define the right design for the clinical investigation (Course 2), and finally, how to ensure optimal compliance in the process of developing a clinical investigation plan and ensure traceability throughout the clinical investigation as covered in course 3.
All courses are compliant with the requirements as stated in ISO 14155:2011, 21 CFR Part 11 and Japanese ICH for medical devices.
Upon completion of this course, trainees will be able to correctly and successfully:
|Course Title Click on a title to view course description||ID||Duration|
|Format and Structure of a Medical Device Clinical Investigation Plan/Protocol||N140||42|
|Designing a Strategic Medical Device Clinical Investigation Plan/Protocol||N141||90|
|Clinical Protocol Writing Process and Ensuring Compliance||N142||35|