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Clinical Informatics & Medical Statistics Research Center

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Clinical Trials Research Program

 


Clinical Trials Research Program

1、The purpose
       The biotechnology pharmaceutical industry is the key direction of national health and national economic development. In order to break through the bottleneck of biotechnology pharmaceutical development, clinical research of translational medicine has emerged. The main focus is on connecting basic research to clinical trials (Bench to Bedside). Therefore, under the "Building Biomedical Science and Technology Island Project" led by the Executive Yuan, the Department of Health and the Ministry of Economic Affairs will promote the research on the connection and integration of new drug research and development stages, and strengthen the clinical trial environment construction verification and accelerate the clinical energy industrialization. Therefore, the cultivation of relevant clinical research talents should be more in line with the needs of industries (such as pharmaceutical companies, Contract Research Organization (CRO) and medical institutions, etc.) to shorten the gap between industry and education. In clinical practice, the Clinical Research Administration (CRA) and the Clinical Research Coordinator (CRC; Clinical Research Nurses, CRN), regardless of the initial preparation, process control, and communication of clinical trials Coordination, executive management, scientific and complete assurance of test data, subject safety protection, computer data analysis and management play an indispensable role. However, there are currently no more than 160 colleges and universities in China that have set up clinical research-related courses or departments to cultivate clinical research talents that are urgently needed in the society. Therefore, the "Clinical Trials Research Program" has been set up. Through the integration and planning of the courses currently offered by the various departments of the medical school, together with the newly introduced clinical trials, clinical research management, clinical trial data processing practices, clinical trials, and experimental design, drug epidemiology and medical technology assessment, advanced clinical trials and other courses. To cultivate the clinical research talents and manpower needed in the relevant industries in Taiwan.

2、The target
        This course provides courses related to clinical research, which will enable students to have a deeper understanding of the industry and invest in clinical research areas, such as Clinical Research Administration (CRA) and Clinical Research Coordinator (CRC). Increase students' chances of employment after graduation. After completing this course, you will be able to understand:
  1. Clinical research practice
  2. Clinical research regulatory affairs
  3. Clinical research management and control
  4. Clinical research implementation and monitoring
  5. Design and implementation of clinical trials for drugs and medical devices
  6. Clinical research data processing and analysis
  7. How to ensure the scientific and completeness of research data
  8. How to complete clinical research plans and reports

 

3  Basis: According to the Chang Gung University course setting principle

4、  Set-up department
       The course is planned by 
Graduate Institute of Clinical Medical Sciences」、「School of Nursing andClinical Informatics and Medical Statistics Research Center.
All university departments and postgraduate of the university can optional .

 
5、Practice credits:「Clinical Trials Research Programmust be repaired 14 credits.

6、Program principalJr-Rung Lin,Ph.D. (Ext3756, E-mailjr@mail.cgu.edu.tw)
 
7、Course Title

I.    Clinical Research Administration(CRA) and the Clinical Research Coordinator(CRC) common compulsory basic courses

Course Title

Credits

Department

Statistics related courses(Required course)

2

All departments of the school

Research Methods related courses

2

All departments of the school

Epidemiology related courses

2

All departments of the school

Clinical Pharmacy

2

All departments of the school

Pharmacology

2

All departments of the school

Health Care Ethics

2

All departments of the school

Biochemistry

2

All departments of the school

Biochemical Engineering

2

All departments of the school

Biomedical Engineering

2

All departments of the school

Must choose 2 courses(At most 6 credits)

II. Clinical Research Administration(CRA) and the Clinical Research Coordinator(CRC) common elective courses

Course Title

Credits

Department

Introduction to Clinical Trials

2

Graduate Institute of Clinical Medical Sciences

Experimental Designs

2

Graduate Institute of Clinical Medical Sciences

Clinical TrialA Practical Approach

2

Graduate Institute of Clinical Medical Sciences

Advanced Clinical Trial Seminar

3

Graduate Institute of Clinical Medical Sciences

Health Technology Assessment

2

Graduate Institute of Clinical Medical Sciences

Statistical Analysis of Clinical Trial Data

3

Graduate Institute of Clinical Medical Sciences

Longitudinal Data Analysis

2

Graduate Institute of Clinical Medical Sciences

Advanced Clinical Trial

3

Graduate Institute of Clinical Medical Sciences

Pharmacoepidemiology

2

Graduate Institute of Clinical Medical Sciences

Must take 4 courses( At least 8 credits)