Managing Data Management: Lessons from a Large CMS Demonstration Project

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...

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,...

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...

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...

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...

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...

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...

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...

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...

Overview: This online course will provide information on the purpose and components of a research protocol and helpful strategies for writing a protocol draft with an Institutional Review Board reviewer’s perspective in mind. Three steps to writing an abstract, the...