ACR628 - Regulatory Compliance and Research Ethics

General

Prefix

ACR

Course Number

628

Course Level

Graduate

Instruction Mode

Lecture

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.

Prerequisites

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.

Course Outline

Dependencies