Initiation Visit

Learning Objectives

Upon successfully completing this course, learners will be able to:

• Prepare an investigator file or regulatory binder
• Optimize efficiency in the preparation, conduct, and follow-up of initiation visits
• Create a training plan for each member of the clinical investigation site
• Develop logistics and methods to efficiently begin a medical device clinical investigation at an investigation site
• Ensure overall regulatory compliance with all clinical investigation plan requirements
• Establish open communication with site personnel, which is crucial for efficient collaboration

Who Should Enroll

Monitors, clinical project managers, investigators, study coordinators, regulatory, quality assurance, or marketing professionals involved in the process of initiating  medical device clinical investigations, and clinical professionals from the pharmaceutical industry wanting to understand medical device clinical investigation initiation visits are all welcome to participate in this course.

Prerequisite Knowledge

An understanding of the following material is required:

• Basics of good clinical practice
• Tasks that come before initiation visits, such as clinical investigation plans and investigator brochures
• Medical device regulatory environment
• Requirements for ethics committee or institutional review board submission processes
• The site qualification process and all action items resulting from such a process

General Requirements for WMDO Courses

• Course Access Duration: Each course is available for 60 days from the date of assignment.

• Quiz Completion: Users are allowed 2 attempts to complete each quiz, with a minimum passing score of 75%.