Communications and Reporting for Clinical Trials
General
Prefix
ACR
Course Number
636
Course Level
Graduate
Instruction Mode
Lecture
Department/Unit(s)
College/School
College of Science and Engineering
Description
Regulatory reporting requirements related to the clinical research of medical products. Communication skills and required documentation.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Describe the steps to develop an ongoing working rapport with FDA including Pre-Submission meetings, teleconference calls, scientific meetings, adverse event reporting, and the final report of the clinical study.
Outcome
Understand clinical research documents used in the different phases of the medical product development life cycle (concept formation, feasibility determination, pivotal clinical trials, support of regulatory submissions, scientific writing and post-market surveillance activities), including Investigator Brochure, Final Study Report, Study newsletter, subject study materials, clinical study metrics, scientific abstracts, presentations, and scientific manuscripts.
Outcome
Understand and apply the FDA Reporting Requirements for Investigational Device Exemptions (IDE) and ISO 14155 and MEDDEV requirements.
Outcome
Demonstrate the ability to write effective clinical reports.
Outcome
Demonstrate applied clinical and regulatory knowledge to problem-solve on hypothetical case studies, to determine the course of action, to choose an appropriate communication document, and prepare the proper documentation for implementation.
Outcome
Understand and apply requirements for clinical trial registration.