Program Overview

Program Overview

The program is a systematic assessment of the device’s safety and/or efficacy that uses human participants. This course will initially guide students to know the guidance and regulation of clinical trials especially in the field of medical device.

Program Objectives

The objectives of the program are to guide students to know the regulation of medical device clinical trials and understand how to plan and execute a clinical research by themselves.

Program Requirements

• Course discussions
  • Oral presentations
  • Final report

Program Structure

The program is structured into 16 weeks, with the following topics covered:

• Week 1: Course Introduction
• Week 2: Clinical Research Tasks
• Week 3: Essential Documents for Clinical Trials
• Week 4: Responsibilities of Investigators Conducting Research Involving Human Participants
• Week 5: Adverse Event Identification and Reporting
• Week 6: Statistical Methods in Medical Device Clinical Trials
• Week 7: Clinical Study Report
• Week 8: Medical Device Regulations, Combination Products, Research Committees
• Week 9: Design Issues in Medical Device Research
• Week 10: Investigator-Initiated Studies
• Week 11: Ethics in Clinical Research
• Week 12: Choice of Control Group and Related Issues in Clinical Trials
• Week 13: Regulatory Challenges for Medical Device
• Week 14: Challenging FDA PMA Cases
• Week 15: Clinical Validation of AI Software in Medical Imaging
• Week 16: Final Report

Program Details

• Course Number: MDI8032
• Course Identification Code: 458 D0810
• Credits: 2
• Type: Elective
• Department: Institute of Medical Device and Imaging / Precision Health Master's Program / Precision Health Doctoral Program
• Instructor: 蕭輔仁 (Shaorong Xiang)
• Class Time: Monday, 6, 7
• Classroom: 基醫1222
• Category: 2
• Enrollment Limit: 15 students
• Language: English
• Core Competency and Course Planning Association Map
• Note: This course is taught in English. Students are required to take at least one of the three courses: Medical Device Commercialization, Medical Device Clinical Trials, and Translational and Bridge Medical Special Topics.

Assessment Method

• 50%: Attendance, Presentation, and Discussion
• 50%: Final Report

Accommodation for Students with Difficulties

• A3: Provide students with flexible ways of attending courses
• B6: Mutual agreement to present in other ways between students and instructors
• D1: Negotiated by both teachers and students

Course Progress

The course progress is updated every five minutes during the enrollment period.

Enrollment Status

• Already Enrolled: 0/15
• Remaining Quota: 0
• Registered: 0

Recommended Reading

• Abdel-aleem, Salah M. The design and management of medical device clinical trials: strategies and challenges. John Wiley & Sons, 2011.
• Abdel-Aleem, Salah M. Design, execution, and management of medical device clinical trials. John Wiley & Sons, 2009.
• Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar, The future of medical device regulation: innovation and protection I, 2022.
• Tong, Raymond (Raymond Kai-yu), Wong Jack. Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, 2022.