Program Description

Designing a Strategic Clinical Investigation Plan

Estimated Learning Duration of the Program:
167
Program Description:

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. 


Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Write a CIP using suitable format and structure that meets regulatory requirements – define a template
  • Apply the different decision factors leading to a comprehensive and appropriate design of a clinical investigation plan
  • Comply with the different regulatory requirements throughout the world while designing the clinical investigation plan
  • Ensure an efficient process of writing, reviewing and updating of a clinical investigation plan

Program Pricing

Prices have not been set for this program.