The Close Down Visit
Course Description:
This course outlines the methods and essential information needed to perform an effective close-down or premature termination of a clinical investigation, including the preparation, conduct, and follow-up of such visits.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Recognize when a clinical investigation must be prematurely terminated or suspended in one or all clinical investigation sites
- Perform the necessary activities to resume a clinical investigation that was previously suspended
- Prepare and conduct a close-down visit
- Ensure accurate archiving
- Optimize communication with the clinical investigation site and ensure strong relationships for future collaboration
Who Should Enroll:
Monitors, clinical research associates, clinical trial assistants, study coordinators, and sales and marketing professionals involved in clinical investigations are all encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following material is required:
- A thorough understanding of good clinical practice
- The Periodic Monitoring Visit (ID 56)