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

  E-mail: dsms@tmu.edu.tw


Members

Chun Yang

Director

Tel: 02-6620-2589 #15302
E-mail: sheep456789@tmu.edu.tw

1. Administrative Management and Strategic Planning for the Office of Human Research
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

Information Operations

Chia-Hua Sung

Administration Staff

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

1. Schedule Management for the Dean of the Office of Human Research
2. Website Management of the Office of Human Research
3. Management of the Human Research Audit System (HRAS)
4. Management of the Clinical Trial Management System (CTMS)
5. Management of Human Research Committee Meetings
6. Management of the official documents of the Office of Human Research

Ko-Hsin Hsu

Administration Staff

Tel: 02-6620-2589 #15321
E-mail: san5203386@tmu.edu.tw

1. Data Management for the Office of Human Research
2. Analysis of Clinical Trial Landscape
3. Management of the Clinical Trial Management System (CTMS)
4. Liaison for the Clinical Trial Management System (CTMS)
5. REDCap System Setup and Maintenance

Audit Operations

Wan-Rong Shieh

Administration Staff

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

1. Audit of Cases at Taipei Medical University Hospital and Shuang Ho Hospital
2. Schedule Management for Vice Dean
3. Management of Facilities and Equipment for the Office of Human Research
4. Human Research Education and Training
5. Project Management of Clinical Trial Incentive Payments
6. Project Management for Optimization of Clinical Trial Fee Standards

Shang-Ting Tsai

Administration Staff

Tel: 02-6620-2589 #15322
E-mail: 113078@w.tmu.edu.tw

1. Audit of Cases at Taipei Medical University and Taipei Municipal Wanfang Hospital
2. Support for Human Research Education and Training
3. Management of Office of Human Research Meetings
4. Execution of Tasks Related to Meetings of the Center for Human Research Protection (CHRP)


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