Data Safety Managing Section

About DSMS

Office of Human Research includes the Data Safety Management Section (DSMS), which is primarily responsible for the quality audit of human research and the protection of research subjects' rights at Taipei Medical University and its affiliated hospitals. This section ensures compliance with human research protocols, standard operating procedures, and relevant regulations, actively implementing the Human Subjects Research Act.

Mission

  Human Research Audit

We are responsible for auditing and monitoring risks in human research cases, ensuring that violations are promptly identified and addressed through random inspections. This effectively maintains compliance standards and reduces risks.

  Administrative Management for the Human Research Office

We manage the single administrative contact point for the Human Research Office, handling document management and report generation, while assisting with the implementation and management of clinical trial systems. This ensures overall administrative efficiency.

  Departmental Project Management

We assist in managing clinical trial incentive programs and fee standardization projects, ensuring that all projects stemming from clinical trials are successfully executed and meet their objectives.


Contact

  Email: dsms@tmu.edu.tw


Members

Chun Yang

Te-Yu Kao

Director

Tel: 02-6620-2589 #16313
Email: sheep456789@tmu.edu.tw

1. Execute administrative tasks for the Ministry of Health and Welfare’s “Innovative Excellence Program for Clinical Trials” Project
2. Budget Coordination Management for the Office of Human Research
3. Planning and Organizing Major Events for the Office of Human Research
4. Overall Management of Data Safety Managing Section

1st Substitute: Chia-Hua Sung
2nd Substitute: Wan-Rong Shieh

Chia-Hua Sung

Administration Staff

Tel: 02-6620-2589 #15303
Email: kakas@tmu.edu.tw

1. Manage the Office of Human Research website
2. Administer the Human Research Audit System (HRAS)
3. Manage the Clinical Trial Management System (CTMS) for real-time trial oversight
4. Schedule, execute, and manage meetings of the Human Research Committees

1st Substitute: Wan-Rong Shieh
2nd Substitute: Te-Yu Kao, Director

Wan-Rong Shieh

Administration Staff

Tel: 02-6620-2589 #15304
Email: kaoru45200@tmu.edu.tw

1. Manage schedules for the Dean of the Office of Human Research
2. Responsible for the audit of human research projects at TMU Hospital and Shuang Ho Hospital
3. Conduct training programs on human research auditing
4. Manage official communication and correspondence for the Office of Human Research
5. Maintain and manage facilities and equipment of the Office of Human Research

1st Substitute: Shang-Ting Tsai
2nd Substitute: Te-Yu Kao, Director

Shang-Ting Tsai

Administration Staff

Tel: 02-6620-2589 #15322
Email: 114042@tmu.edu.tw

1. Responsible for the audit of human research projects at TMU and Wan Fang Hospital
2. Support human research education and training activities
3. Schedule, execute, and manage internal meetings of the Office of Human Research
4. Coordinate meeting-related tasks for the Center for Human Research Protection (CHRP)

1st Substitute: Wan-Rong Shieh
2nd Substitute: Chia-Hua Sung



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