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Event NameSOCRA 2016
Event Date(s) Friday, September 30, 2016  to Sunday, October 02, 2016
Event Location Palais des congres de Montreal (Montreal Convention Center)
Montreal, Quebec
Cost$825 - $800
DescriptionWHO SHOULD ATTEND: Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms.

LEARNING OBJECTIVES: Upon completion of this course the attendee should be able to:

• Discuss new guidance requirements to ICH GCP
• Discuss the important role clinical research plays in orphan disease
• Discuss informed consent from an NIH perspective
• Discuss the use of cost analysis for determining study feasibility
• Describe how the patient safety movement can help the responsible conduct of research
• Discuss the background and current state of the Canadian Device Industry
• Discuss the latest advancements in clinical trial billing and compliance
• Discuss the process for creating a research protocol
• Discuss the role of human factors testing in drug and device trial safety and efficiency
• Discuss monitoring via remote access to electronic medical records
• Discuss the formation and use of research subject advocacy groups
• Discuss best practices for conducting investigator-initiated research
• Discuss the regulatory requirements for conducting multinational NIH studies
• Discuss key elements in negotiating Canadian Clinical Trial Agreements
• Discuss challenges faced and best practices in behavioral health research
• Discuss the FDA and Health Canada perspective on homeopathic products as drugs
• Discuss key factors and best practices for clinical site selection
• Describe targeted monitoring
• Discuss key tools to help run an effective project and minimize risk
• Discuss the coordinator’s “do it all” role at a small site
• Discuss simple tools to help collect, organize, and analyze data to drive improvements at sites
• Discuss recruiting healthy controls in the pediatric population
• Discuss new and different approaches to enrollment
• Discuss exceptions from informed consent
• Discuss the regulatory requirements for IRBs
• Discuss common inspection deficiencies and how to avoid them
• Discuss best study start up practices
• Describe how to apply lean methods and processes to clinical research site management
• Discuss implementing quality design techniques into clinical trial projects
Host CompanyN/A
Contact Information Phone: 215-822-8644
Fax:   800-762-7292 
Email: N/A
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