Format and Structure of a Medical Device Clinical Investigation Plan/Protocol
This course provides an in-depth review of the contents and format of a clinical investigation plan according to ISO 14155 and 21 CRF part 812 as well as Japanese ICH for medical devices while pointing out how to handle the subtle differences there may be between the different regulatory systems.
Upon completion of this course, trainees will be able to correctly and successfully:
- Establish an outline of a clinical investigation plan for an international medical device clinical investigation.
Clinical project directors or senior clinical project managers, senior regulatory managers.
Have a basic understanding of good clinical practices as outlined in ISO 14155 (see certification program “ISO 14155: In Depth Review”) and know the regulatory requirements of the countries where the clinical investigation will need to be conducted. It is advisable to understand the major regulatory systems in the world (EU, US, Japan) as outlined in course 145: “The European Union Regulatory System for Medical Devices”, course 146: “The Japanese Regulatory System for Medical Devices”, course 121: “US FDA Investigational Device Exemption (IDE) Overview”, course 92: “US FDA 510(k) Notification Process” and further courses on Pre-Market Application in the US.