Regulatory Compliance and Research Ethics
General
Prefix
ACR
Course Number
628
Course Level
Graduate
Instruction Mode
Lecture
Department/Unit(s)
College/School
College of Science and Engineering
Description
Regulations associated with research ethics, regulatory and global standards for research conduct, and how to problem solve real-world cases. Regulations and standards for clinical trials. Communication and ethical considerations in negative product-performance situations.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Describe Good Clinical Practices (GCP) of the FDA along with an introduction to international clinical regulations.
Outcome
Articulate the regulatory requirements associated with the clinical evaluation of unapproved and approved medical devices in humans.
Outcome
Describe how and when FDA regulations are applied in clinical research and the importance of regulatory compliance.
Outcome
Identify and interpret IDE regulations and guidance documents or standards that are applied in clinical research
Outcome
Define study objectives for multiple audiences (FDA, Centers for Medicare and Medicaid Services (CMS), physicians and patients) and analyze/interpret statistical considerations associated with designing a clinical trial.
Outcome
Describe what clinical reports are required and what clinical data needs to be reported; Define the maintenance activities for an IDE and the post-trial approval process and content.
Outcome
Cite and synthesize historical events and examples of human rights violations that lead to the development of research ethics, regulations, and standards for protecting human subjects to advise study teams on expectations for the conduct of ethical clinical studies according to international standards.
Outcome
Describe the pre-trial submission process including pre-IDE meetings and IDE application contents.
Outcome
(RAS) Describe the principles of experimental design, sample size estimation, and statistical analysis methods to use in clinical trial protocols, using mathematical and computational thinking.
Outcome
Describe the approval process for International Clinical Trials.