IDE Regulations and Clinical Trial Design
General
Prefix
RAS
Course Number
631
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
Conducting clinical research on unapproved medical devices. Pre and post market approval requirements and logistics of conducting clinical trials. Principles of clinical trial design. Common study designs and scientific and practical advantages and disadvantages. Clinical Trial Life Cycle.
Prerequisites
Credits
Min
4
Max
4
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Explain how and when clinical trial regulations are applied.
Outcome
Identify and interpret FDA investigational device exemption regulations, guidance documents, standards, and reporting requirements.
Outcome
Describe the principles of scientific design, the process of writing clinical study objectives and endpoints, the methods of determining sample sizes and performing statistical analysis, and common methods for collection and analysis of clinical data.
Outcome
Identify and formulate advice on ethical research practice and conduct to protect human subjects.
Outcome
Discuss the process phases of a clinical trial and basic clinical paradigms commonly used to determine safety and effectiveness/efficacy.
Outcome
Describe the submissions to support pre- and postmarket clinical trials.
Outcome
Identify strategies to communicate and report negative product-performance situations.
Outcome
Define maintenance activities, the post-trial approval process and content.
Dependencies
Courses
RAS631
is a
prerequisite
for:
Programs
RAS631
is a
completion requirement
for: