Online Class: Handling Investigational Drug Products
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| | Course Cost: 6 Month Subscription Course (no Certificate) = $45.00 Course with CEU Certificate* = $70.00 | * Instantly download, print, and share your CEU Certificate at course completion (additional shipping/handling charges apply for hard copy delivery).
UniversalClass™ offers many wonderful learning tools including an online portfolio service that manages all your course completions and CEUs.
 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. Learning Outcomes By successfully completing this course, students will be able to:
- Summarize handling investigational products.
- Summarize labeling an investigational drug product.
- Describe control of investigational drug products.
- Describe storage and environmental monitoring.
- Summarize subject's compliance and accountability, and
- Demonstrate mastery of lesson content at levels of 70% or higher.
Course Lessons |  | Lesson 1: Introduction to Handling Investigational ProductsAttendees 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 ProductThis lesson will review the FDA and Health Canada Protection Branch content requirements for investigational product's label . | Lesson 3: Control of Investigational Drug ProductsThis class reviews the type of controls expected for investigational drug products. | Lesson 4: Storage and Environmental MonitoringThis class describes storage and documentation requirements for investigational products. | Lesson 5: Subject's Compliance and AccountabilityThis class shows how to calculate subjects' drug compliance and investigational product reconciliation. It also provides a sample inventory log. |
Additional Information | Course Title | : | Research Quality: Handling Investigational Drug Products | | CEU Value | : | | | Standard | : | Course Adheres to the ANSI/IACET 1-2007 Standard | | Accreditation | : | | | Languages | : | English - United States, Canada, United Kingdom, Australia, New Zealand, and other English speaking countries | | Course Number | : | 33637 | | Course Type | : | Professional (Intermediate Level) | | Course URL | : | | | Course Rating | : |  | | Instructor | : | | | Syllabus | : | | | Grading Policy | : | Earn a final grade of 70% or higher to receive a CEU Certificate documenting CEUs earned | | Assessment Method | : | Lesson assignments and review exams | | Duration | : | Continuous: Enroll anytime! | | Requirements | : | View Technical Requirements | | Course Fee | : | Basic Course: $45.00 (no CEU Certificate) | | | | | NOT FOR COLLEGE CREDIT 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, certification or educational requirements.
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