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Course Description
This course describes Good Clinical Practices requirements for the sponsor and the investigator as it relates to receiving, storing, dispensing, and returning or destroying investigational drug products. Additionally, attendees will learn how to do drug accountability, drug reconciliation and maintain the proper records in case of FDA or regulatory agency inspection.
Who should attend? This course is designed for all who interact with investigational drug supplies. Specifically, Clinical Monitors (i.e. CRAs), Clinical Research Coordinators, Principal/Clinical Investigators, Sub-Investigators, Auditors, Project Managers and Sponsors.
Course Lessons
Lesson 1: Introduction to Handling Investigational Products
Attendees will learn how GMP applies in clinical research. Attendees will also learn the FDA requirements for sponsors and investigators handling investigational drug products. This course additionally provides a review of common clinical research terms f
Lesson 2: Labeling an Investigational Drug Product
This lesson will review the FDA and Health Canada Protection Branch content requirements for investigational product's label .
Lesson 3: Control of Investigational Drug Products
This class reviews the type of controls expected for investigational drug products.
Lesson 4: Storage and Environmental Monitoring
This class describes storage and documentation requirements for investigational products.
Lesson 5: Subject's Compliance and Accountability
This class shows how to calculate subjects' drug compliance and investigational product reconciliation. It also provides a sample inventory log.
Optional Certificates Awarded
Certificate of Attendance
Certificate of Class Participation
Certificate of Merit
Certificate of Outstanding Achievement
Certificate of Academic Excellence
In addition to the standard Certificate of Course Completion, Merit Awards may be issued by the instructor at his/her own discretion and are based on student achievement. Merit awards also incur an additional $30.00 processing fee that covers the customization, printing, and delivery of the award, as well as access to the UniversalClass™ Portfolio Service that documents your achievements online. Official Merit Awards have a serial number that verifies the authenticity of the award (great for employers to verify your achievement).
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Additional Information
Course Title
:
Research Quality: Handling Investigational Drug Products
This is a non-credit course, and is provided for your personal enrichment.
This course is not intended to be a substitute for any state, government, licensing, or educational requirements.
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