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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

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

Mastering oral presentations. 20% Regulatory report format requirements. 20% Written communication to regulators. 20% Meetings with the U.S. Food and Drug Administration (FDA). 15% International clinical trial reporting requirements. 15% Project planning and project management. 10%

Dependencies

Programs

ACR636 is a completion requirement for: