Curriculum

Required Courses (14 Credits)
NURS 582	Foundation of Good Clinical Practice in Clinical Trials Mngmt	3.00 credits
NURS 583	Operational Leadership in Clinical Trials Management	3.00 credits
NURS 584	Current Topics in Clinical Trials	3.00 credits
NURS 585	Clinical Trials Research Practicum	5.00 credits

Course Descriptions

NURS 582 Foundation of Good Clinical Practice in Clinical Trials Mngmt - 3.00 credits

This foundation course in clinical research provides a comprehensive review of the fundamentals of human clinical research. It includes the principles of Good Clinical Practice (GCP?s), regulatory requirements and guidelines, and ethical requirements for human drug and device development in the United States.

Back to course list

NURS 583 Operational Leadership in Clinical Trials Management - 3.00 credits

This course focuses intensely on the integration and application of Good Clinical Practices (GCPs) and regulatory requirements in clinical trials management, including the development of an informed consent and responsibilities of an IRB. There is a strong focus on the financial aspects of study management including developments of study budgets.

Back to course list

NURS 584 Current Topics in Clinical Trials - 3.00 credits

This third course in clinical research builds on the regulatory knowledge and skills learned in the foundation courses and offers an opportunity for the student to explore current topics in clinical trials management. It focuses on the challenges of running a clinical trial including fraud, adverse event reporting and patient recruitment.

Back to course list

NURS 585 Clinical Trials Research Practicum - 5.00 credits

The practicum/project provides an opportunity for the student to operationalize the clinical trials role in appropriate agencies and facilities in conjunction with an expert clinical trials researcher. Emphasis is placed on practical experience in the clinical trials research process. A capstone project will be completed in conjunction with the practicum.

Back to course list