CTSU eCourse: Manage Clinical Trials

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This module offers guidelines for CTSU processes and protocol implementation. The module objectives, shown at right, will guide you through the MANAGE module. Simply click on the objectives to take you to module content sections.

First-time users are encouraged to navigate each of the modules in order—Learn, Register, Review, Manage. As you become familiar with the site contents, you will be able to navigate to specific sections based on your informational need.

Module Objectives
1	Identify specific regulatory documentation, medical records, and laboratory certification that must be maintained according to Federal regulations and Good Clinical Practice
2	Describe the procedure for submission of data to the CTSU
3	Implement the procedures to acquire study agents specific for a protocol on the CTSU menu
4	Demonstrate the procedure for reporting adverse events for patients enrolled through the CTSU
5	Summarize radiation therapy guidelines that will need to be initiated at the study site prior to enrolling patients on CTSU protocols where radiation therapy is a treatment intervention
6	Describe the rationale and process for auditing data obtained for patients enrolled on a CTSU protocol
7	Explain CTSU Quality Assurance