Initiation Visit
This course provides practical guidance and instructions on the preparation, conduct, and follow-up of initiation visits to ensure optimal compliance of all parties involved. It includes several case studies to familiarize learners with the many situations that can occur while conducting initiation visits for medical device clinical investigations.
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
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.
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