Course Title:	Good Clinical Practices for the Clinical Research Team
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Course Description: This course provides a review of the clinical trial process. Starting with the history of regulatory oversight, it reviews each of the steps necessary to develop, initiate and manage a clinical trial according to Good Clinical Practices (GCPs). It provides insight into the roles of the individual members of the clinical research team, and provides a practical approach to preventing the pitfalls associated with many clinical trials. This course is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor. It recognizes that not all clinical trials are conducted under the auspices of a pharmaceutical company and provides the sponsor-investigator as well as the site based clinical research team the information necessary to independently conduct a clinical trial. Particular emphasis is given to the academic based clinical research team when appropriate. This course provides an excellent tool for the training and education of all members of the clinical research team to insure their knowledge and understanding of the clinical research process and GCPs. It is also a helpful tool for sponsors, whether corporate or academic, since it can help verify the required GCP training of investigators and other team members. You should expect to spend approximately 15 hours of study time to complete the course.
Course Title:	Decision Points in Drug Development: Discovery to Launch
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Course Description: This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch. These decisions include identifying a lead, choosing a compound for development, conducting pre-clinical work to assess which drugs should go to clinic, determining that drugs are safe in the clinic, establishing the dose, generating a label, and deciding to file an NDA. A key element of the module is a discussion of how the product label drives the drug development process. The difference between an activity based and a knowledge based drug development process is also addressed. You should expect to spend approximately 5 hours of study time to complete the course. You will have a two-month access after you register for the course.
Course Title:	Clinical Monitoring and Site Management
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Course Description: The goal of this course is to provide a practical orientation to site management and monitoring of clinical studies. The course provides a comprehensive overview of clinical monitoring in the context of the overall drug development process; FDA and HPB regulations; and ICH guidelines for GCP. This course will be delivered completely over the Internet, which means you will progress at your own pace through the course content. The course combines text-based study materials with interactive exercises enabling you to apply what you have learned to on-the-job situations. You should expect to spend approximately 15 hours of study time to complete the course. You will have a four-month access after you register for the course.
Course Title:	Statistical Concepts Used in Clinical Trials
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Course Description: This course will review statistical terminology, provide an understanding of statistics, and explain trial design from a clinician's viewpoint. Most importantly, the course will illustrate how statistical tests are chosen and interpreted. The course is designed to allow you to think like a statistician, but it is not designed to teach you to be a statistician. The course will emphasize the importance of an ongoing collaboration with a statistician. It is this collaboration that creates synergy, enhances creativity, and improves trial design, execution, and analysis. You should expect to spend approximately 12 hours of study time to complete the course. You will have a four-month access after you register for the course.
Course Title:	Applied Good Clinical Practices
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Course Description: This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH. You should expect to spend approximately 15 hours of study time to complete the course. You will have a four-month access after you register for the course.
Course Title:	Pharmacology Online
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Course Description: This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system. Inflammation and anti-inflammatory drugs are next presented, and the course concludes with a discussion of agents used in infectious disease and chemotherapy.
If you have questions or comments, or need additional information or service please contact us at Distance Education Courses or (703) 276-0178. We will be happy to assist you.