Class Syllabus: Research Quality: Handling Investigational Drug Products
|  | |
|
Office Hours: |
8pm-11pm
|
|
Course Meeting Times: |
9pm Tuesday & Thursdays
|
|
|
Course Description
Attendees will learn all of the documentation required by 21 CFR regulations and Good Clinical Practices (GCP) when working with investigational product. We will discuss requirements for the sponsor and the investigator as it relates to receiving, storing, dispensing, storing and returning or destroying investigational drug/device products. Additionally, attendees will learn how to calculate drug accountability, perform drug reconciliation and maintain the proper records in case of FDA or another regulatory agency inspection.
Who should attend? This course is designed for all who interact with investigational drug supplies. Specifically, Clinical Monitors (i.e. CRAs), Pharmacists, Clinical Research Coordinators, Principal/Clinical Investigators, Sub-Investigators, Auditors, Project Managers and Sponsors.
Course Requirements
A very basic knowledge of Good Clinical Practices, Clinical Research processes and/or Good Manufacturing Practices is needed for this course. All materials are provided. An excellent learning tool for new clinical researchers and a re-fresher course for veteran clinicians. Course Goals
The goal of this course is to teach some and remind others of the best practices one should use when working with investigational drug products and devices. Documentation is very important in this process and this course's goal is to ensure researchers know the required content in case of a regulatory (FDA) inspection. Course Materials
All course materials are provided.
Grading Policy
Each completed assignment and exam represents 100% efficiency.
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.
Other Related Classes in Health Professions and Sciences - Medical Terminology 101 This medical terminology course covers the medical language and terminology used by health care professionals everywhere. If you're interested in pursuing a health and science career requiring the ability to communicate with physicians, dentists, or ot...
- Anatomy and Physiology 101 This self-paced anatomy and physiology course will cover all the bodily systems playing a major role in human anatomy. The material is presented in a practical and comprehensive manner. The focus of the course is on the need-to-know facts that must be un...
- Introduction to Chemistry CHEMISTRY: It is Not Your Great-Grandfather's Science Anymore At a minimum, a basic understanding of chemistry is needed for it offers a foundation for comprehending the inner workings of biology (how cells function and the behavior of organisms), as ...
- Introduction to Biology Biology 101 is an excellent learning resource for the college or pre-college student. This logical and easy to understand class is divided into self-paced lessons, complimented with well-written text, diagrams, pictures, critical-thinking assignments an...
- Comprehensive Medical Terminology 1 & 2 This comprehensive medical terminology combination course covers both courses: Medical Terminology 101 and 201. We'll start with the very basics of medical terminology, reviewing word roots, prefixes, and suffixes that make up medical words. We'll then m...
- Medical Terminology 201 Medical terminology is the specific language used by professionals in the medical industry and for success in this field, understanding and communicating in the language is critical. Medical Terminology 201 is an advanced course for those with some expe...
- Project Management 101 Have you ever been involved in a complex project that just did not go the way you wanted? Often failure is pre-ordained due to the approach to the project. The concept of project management exists because it helps assure completion of a project successfu...
- Cell and Molecular Biology 101 From the laboratory to the real world, cell and molecular biology has a far-ranging impact upon everything from the environment to health and medical issues. Cell and molecular biology enables researchers to study the minute world of microbes and cells. ...
- Team Management 101 Team Management Is -- Designing & Developing a Team Committed to a Common Purpose No man will ever make a great leader who wants to do it all by himself or to get all the credit for doing it. (Andrew Carnegie) 'Managing' used to be just tellin...
- Marine Biology 101 Marine biology is the science of saltwater and everything that lives, moves, and filters through it. The word marine in this sense refers specifically to saltwater that you find in oceans, not freshwater, which is found in lakes. When you look at a glob...
- Understanding Business Administration 101 Whether you are already running a business, have yet to start one or have been hired to support a business owner, it is important to know the basics of the business administrative process. This course will trace a path through the inception, setup a...
- Research Quality: Protecting Research Subjects This course will discuss the informed consent process including what to tell patients participating in clinical trials, who should consent patients into clinical trials. We will also discuss what investigators must tell the Institutional Review Board (I...
| | | |
| |
| |
