Online Class: Handling Investigational Drug Products
|  | | | | | Course Cost: 6 Month Subscription Basic Course (no certificate) = $35.00 Course with Online Certificate* = $60.00 |
* Document your course completion with an online certificate (additional shipping/handling charges apply for hard copy delivery). Instantly download, print, and share your certificate and CEUs once awarded. UniversalClass™ offers many wonderful learning tools to help you get the most out of your online course,
including an online portfolio service that manages all your course completions, and a Certificate Verification Service you can use so others may view and verify the authenticity of your awards.
 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 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. |
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).
| | Additional Information | Course Title | : | Research Quality: Handling Investigational Drug Products | | CEU Value | : | | | Course Number | : | 33637 | | Course Type | : | Professional (Intermediate Level) | | Course URL | : | | | Course Rating | : |  | | Instructor | : | | | Syllabus | : | | | Duration | : | Continuous: Enroll anytime! | | Course Fee | : | Basic Course: $35 | | | | |
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, or educational requirements.
Choose from 5 Payment Methods |  | Credit Card Online | | Credit Card through FAX | | Check/Money Order through Mail | | Credit Card over the Phone | | PayPal | | | | To use any of these methods you must press the "Join this Course" button on this screen and go through the online registration process in order to generate the correct order form and correctly process your enrollment. |
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