Class size is limited: Participant enrollment limited to ensure a productive session working over a four day period with four expert industry professionals facilitating training, giving feedback, and actively engaging participants in workshops. This realistic training seminar format provides the optimal adult learning experience by providing energizing exchanges and development of application scenarios related to real life "on-the-job" situations. People retain "90% of what they see, hear, say, and do"*; this course is designed to produce results. * [Knowles, 1990].

Anyone who desires focused therapeutic oncology training and guidance in the proper conduct of clinical trial research. The course content and learning objectives are ideal for:

• Sponsor company clinical trial team members of industry-sponsored drug trials
  • Clinical research associates (CRA) monitors
  • Project managers
  • Data managers
• Study site team members
  • Investigators/Sub-Investigators (physicians)
  • Clinical research coordinators (CRCs)
  • Regulatory administrators
• Clinical research organizations (CROs) team members
  • Account executives
  • Project managers
  • CRA/monitors
• Hospital Staff and Medical University employees
• Transitioning employees
  • Operations staff of clinical research units
• Institutional Review Board/Ethics Committee Member

Upon completion of this session, the attendee should be able to:

• Describe the new paradigm in cancer drug development
• Discuss new cancer therapies
• Discuss the ethical situations unique to cancer clinical trials
• Describe effective investigator selection and patient recruitment strategies
• Describe data considerations for cancer clinical trials
• Explain protocol and statistical considerations for cancer trial design
• Outline the responsibilities of the sponsor, investigator, and IRB for clinical drug trial conduct according to GCPs
• Compare and contrast the project management flow for an oncology trial using paper versus an e-Clinical Trial (EDC) process
• Demonstrate a basic understanding of EDC tasks per PM/CRA/CRC job function
• Perform basic EDC tasks successfully in the computer lab
• Explain the team responsibilities for human safety protection during the conduct of clinical trial research

• Unique Considerations for Clinical Trial Conduct in Oncology
• The Drug Development Process: An Overview
• Good Clinical Practices
• Special Resources for Cancer Trials
• Clinical Trial Site Considerations
• An Overview of Study Activities
• Study Site Clinical Trial Tools of the Tools
• Monitor-CRC Visit Checklist Workshop
• A Critical Look at the Protocol
• Delegating Study Personnel
• Data Management: Now and in the Future
• Data Management: Strategies in Cancer Trials
• Source Documents
  • New Technologies in Clinical Trial Research
  • Data Management Strategies in Clinical Trials
  • Adverse Events and Safety Reporting
  • Fulfilling Data Management Responsibilities
  • Preparing for the Quality Assurance Audit
  • Ethics in Research: The Least of My Brothers on-line one-month ethics class

Includes the FCI Works Course Tools:

• "Lessons From a Horse Named Jim" Duke University [DCRI] textbook
• Resource List - CD-Rom
• Homework & Exam Modules - CD-Rom
• FCI Student Notebook with copy of slides
• "The Least of My Brothers" 1-month on-line ethics course
• Participation in FCI Yahoo Internet group: ClinicalResearchProfessionals
• Course Certificate of Participation
• NYC Guide