Clinical Research Courses

Overview: This presentation will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines...

Program Information: This is a 35 minute internet media player video of a voice over slide show. A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material. Learning Objectives: At the completion of the webinar, participants should be able to: What are source documents? Common Source documents and...

Overview: This talk will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines and...

Program Information: You may happen to work with a colleague or a direct report who is difficult to please. They may have a special opinion and never want to compromise or they may think they are always right and everyone else is wrong. They want to do things their own way and poor you if you obey. Being snappy and arguing can be their norm, at...

Overview: In this presentation the speaker will introduce different practices and principles for how new medicals products are identified as safe and effective, and ultimately introduced into the marketplace. How clinical research came to be and how professionals deal with proving that products are safe and effective will be presented. Lastly,...

Program Information: Ms. O’Kelly Phillips will discuss how data collection and management were structured in a large CMS demonstration project involving multiple data sources, including direct input from 40 partnered nursing facilities. Lessons learned throughout the project with attention to best practices for approaching managing projects with...

Overview: This presentation will provide an overview of the sponsor responsibilities for conducting clinical research. The presentation will address sponsor responsibilities for regulatory submissions, site selection, documentation, and monitoring. Safety and regulatory reporting will also be discussed. As clinical trials expand throughout the...

Program Information: The FDA allows for charging for investigational products used in clinical research under certain circumstances. The federal regulations also state that participants should be informed of any additional costs that may result from participation in research. Recent “research studies” are using this guidance as a loophole to...

Updated December 2024: This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education unit to those who complete the review and correctly answer eight of nine questions. The module is offered...

Program Information: Ms. Rugloski will provide tips and examples for creating and implementing a Project Team Member Transition/Training strategy to ensure effective and efficient project team member transitions. The session will end with an activity comprised of an interactive mind-mapping (‘brainstorming’) exercise with audience participation....