Designed for new oncology clinical trials nurses, study coordinators, and data managers, the Fundamentals of Oncology Treatment Clinical Trials course provides a basic, comprehensive overview of the conduct of oncology treatment trials according to U.S. Regulations and International Conference on Harmonisation guidelines.
Educational Goals/Objectives
At the conclusion of this course, participants should be able to:
Describe the regulations and guidelines applicable to conducting safe and effective oncology treatment clinical trials.
Recognize the basic elements of oncology clinical trial design and protocol development.
Differentiate the roles and responsibilities of institution review boards; sponsors; and investigative sites including investigator, clinical trial nurse/study coordinator, and data manager.
Discuss the elements of the informed consent document and describe the process for obtaining consent/assent.
Discuss data management, regulatory compliance, and quality assurance processes used in clinical trials.
Discuss ethical issues related to clinical trials, specifically oncology treatment clinical trials.
