Minor Program in Clinical Trials and Regulation of In Vitro Diagnostic (IVD) Products

Level: Undergraduate Minor

Program Code: 1010

Duration: One Year

Program Objectives

This minor program is designed to equip students with interdisciplinary knowledge and practical competencies in the clinical evaluation and regulatory management of in vitro diagnostic (IVD) products. Upon completion, students will:

—  Demonstrate strong professional ethics and legal awareness, and comply with medical device-related regulations and ethical standards.

—  Understand the fundamental principles, regulatory requirements, and practical procedures of IVD clinical trials, supported by solid foundation in medical laboratory science and regulatory science.

—  Be capable of independently designing IVD clinical trial protocols, conducting data management and statistical analysis, and addressing ethical review and regulatory compliance issues.

—  Develop interdisciplinary collaboration skills and a global perspective, preparing for careers in IVD enterprises, contract research organizations (CROs), regulatory agencies, and healthcare institutions.

Core Courses

—  IVD Regulatory System and Registration Management

—  Principles of Clinical Trial Design

—  Exemption Pathways and Technical Requirements for Clinical Evaluation

—  Good Clinical Practice (GCP)

—  Clinical Trial Institution Management and Ethics Review

—  Test Validation and Product Technical Documentation

—  Data Management and Statistical Analysis

—  Case Studies in Clinical Trial Design for High-Risk IVD Products

—  Clinical Trial Audit and Regulatory Compliance

—  International IVD Regulations: CE and FDA Comparison

—  Simulated End-to-End IVD Clinical Trial Practice

Career Pathways

The Minor in Clinical Trials and Regulation of IVD Products is open to students majoring in Medical Laboratory Technology, Clinical Laboratory Diagnostics, and related disciplines. Through coursework, case-based learning, simulation training, and group projects, students gain systematic knowledge of the full clinical trial lifecycle for IVD products, including regulatory framework, trial design, GCP standards, ethic review, data management, and international registration pathways.

Graduates of this program are well prepared for roles in IVD companies, CROs, regulatory authorities, and healthcare institutions, working in clinical trial design, regulatory submission, quality management, and technical evaluation. The program enhances students’ professional competitiveness and adaptability in the rapidly evolving medical device and diagnostic industry.