Clinical Protocol Writing Process and Ensuring Compliance
This course covers the essential regulatory and ethics requirements ensuring compliance, traceability and efficiency in the process of a clinical investigation.
The clinical investigation plan is the blueprint that must ensure the efforts lead to meaningful results and this course will cover most of the essential steps to make; including ensuring a good quality assurance system to avoid pitfalls.
Upon completion of this course, trainees will be able to correctly and successfully:
- Ensure a process is in place for efficient writing of a clinical investigation plan and prepare the necessary standard operating procedures and templates to optimize global compliance.
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 the following courses:
- ID 145: “The European Union Regulatory System for Medical Devices’,
- ID 146: “The Japanese Regulatory System for Medical Devices”,
- ID 121: “US FDA Investigational Device Exemption (IDE) Overview”,
- ID 92: “US FDA 510(k) Notification Process”, and further courses on pre-market application in the US.
Understand the contents of a clinical investigation plan as outlined in Course 140 and how to develop a design that will comply with most of the regulatory requirements throughout the world as outlined in Course 141.