Polaris

Programs Available through Polaris• Overview of Drug Development• Overview of Clinical Research• History of the Regulations• FDA Structure and Processes• Regulations that Affect Clinical Research (FDA and ICH)• The Responsibilities of Sponsors, Monitors, and Site Personnel• The Responsibilities of Contract Research Organizations• The Role of the Institutional Review Board• Preparing Documents for Study Initiation• Selecting Investigators and Study Sites• Developing Protocols and Case Report Forms• Conducting the Study Initiation Visit• Developing and Obtaining Informed Consent• Conducting the Interim Visit• Adverse Experiences and Serious Adverse Experiences• Editing Case Report Forms• Interacting with the Study Coordinator• Reviewing Regulatory Documents• Case Report Form Tracking and Management• Managing Clinical Trial Material/Drug Accountability• Writing Trip Reports and Follow-Up Letters• Role of Data Management in the Clinical Research Process• Safety When Traveling• Writing Protocols• Designing Case Report Forms• FDA Audits• Detecting Fraud in Clinical Research© 2004 by CRC Press LLC