Communications and Reporting for Clinical Trials
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General
Prefix
ACR
Course Number
636
Course ID
00017010-2024-08-26
Course Level
Graduate
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.
Prerequisites
Credits
Min
3
Max
3
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Explain the reporting requirements for Investigational Device Exemptions (IDEs), New Drug Applications (NDAs), International Organization for Standards (ISO) 14155, and EU Medical Device Regulation (MDR).
Outcome
Describe the steps to develop a working rapport with the FDA, including pre-submission meetings, teleconference calls, scientific meetings, adverse event reporting, and the final clinical study report.
Outcome
Explain the importance and key components of clinical research documents used in the different medical product development phases, including Investigator Brochures, Final Study Reports, study newsletters, abstracts, and manuscripts.
Outcome
Write effective clinical study reports.
Outcome
Design and implement an effective project plan using applied clinical and regulatory knowledge to determine the appropriate course of action and associated communication documents.
Course Outline
Course Outline
Dependencies
Programs
ACR636
is a
completion requirement
for: