IDE Regulations and Clinical Trial Design

General

Prefix

RAS

Course Number

631

Course Level

Graduate

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

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: