ACR636 - Communications and Reporting for Clinical Trials

General

Prefix

ACR

Course Number

636

Course Level

Graduate

Instruction Mode

Lecture

Description

Regulatory reporting requirements related to the clinical research of medical products. Communication skills and required documentation.

Prerequisites

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.

Course Outline

Dependencies