Hiroshima University Syllabus

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Academic Year 2023Year School/Graduate School Graduate School of Biomedical and Health Sciences (Master’s Course)
Lecture Code TB011203 Subject Classification Specialized Education
Subject Name 臨床研究方法論
Subject Name
Subject Name in
Basic and Advanced Training on Methodology for Clinical Research
タナカ ジュンコ,ニシカワ マサコ,コウノ ヨウイチ,フクマ シンゴ,タムラ ナツコ,コ コ,アキタ トモユキ,スギヤマ アヤ
Campus Kasumi Semester/Term 1st-Year,  Second Semester,  Second Semester
Days, Periods, and Classrooms (2nd) Tues13-14:MED Rm 2
Lesson Style Seminar Lesson Style
(More Details)
Seminar, Practice
Lecture 1-12, face-to-face class (For students who can' t attend face-to-face, a video of the class is uploaded to moodle. If you are taking the course from moodle, please make sure to take the course and submit your assignment by the deadline stated in moodle. Those who have not submitted their assignments are considered absent.)

Lecture 13-15, group work (face-to-face or online:teams) No on-demand. If student cannot attend, contact to Dr. Akita.  
Credits 2.0 Class Hours/Week   Language of Instruction B : Japanese/English
Course Level 5 : Graduate Basic
Course Area(Area) 27 : Health Sciences
Course Area(Discipline) 01 : Medical Sciences
Eligible Students Master's course students
Keywords SDG_03
Special Subject for Teacher Education   Special Subject  
Class Status
within Educational
(Applicable only to targeted subjects for undergraduate students)
Criterion referenced
(Applicable only to targeted subjects for undergraduate students)
Class Objectives
/Class Outline
Student will be able to plan their research based on fundamental theories of medical research, epidemiological study and clinical trial. 
Class Schedule Lesson 1 (10/3) Basic biostatistics I  (Tomoyuki Akita/ Junko Tanaka)(face-to-face)
Lesson 2 (10/10) Medical research and drug development (Yoichi Kohno)(face-to-face) 
Lesson 3 (10/17) Basic biostatistics II (Tomoyuki Akita)(face-to-face)
Lesson 4 (10/24) Basic biostatistics III (Tomoyuki Akita)(face-to-face) 
Lesson 5 (11/7) Practice in Data analysis (Tomoyuki Akita)(face-to-face)
Lesson 6 (11/14) Topics in Epidemiology & Biostatistics (Tomoyuki Akita)(face-to-face)
Lesson 7 (11/21) Designing Clinical Research Project (Shingo Fukuma)(face-to-face)
Lesson 8 (12/28) Basic observational study (Ko Ko)(face-to-face)
Lesson 9 (12/5) Basic clinical trials (Masako Nishikawa)(on-demand) 
Lesson 10 (12/12) Planning of clinical trials I (Masako Nishikawa)(on-demand)
Lesson 11 (12/19) Planning of clinical trials Ⅱ (Tomoyuki Akita)(face-to-face)
Lesson 12 (1/9) Ethical guidelines for clinical research (Tomoyuki Akita)(face-to-face)
Lesson 13 (1/16) Practice in protocol of clinical trial and epidemiological study, Part 1(Aya Sugiyama/ Natsuko Tamura/ Ko Ko/Tomoyuki Akita)(face-to-face or Teams)
Lesson 14 (1/23) Practice in protocol of clinical trial and epidemiological study, Part 2(Aya Sugiyama/ Natsuko Tamura/ Ko Ko/ Tomoyuki Akita)(face-to-face or Teams)
Lesson 15 (1/30) Presentation of protocol of clinical trial and epidemiological study(Aya Sugiyama/ Natsuko Tamura/ Ko Ko/ Tomoyuki Akita)(face-to-face or Teams)

3 times reports and final presentation

Order of lecture may be changed.  
Michael Harris & Gordon Taylor. Medical Statistics Made Easy. Scion Pub Ltd
Aviva Petrie & Caroline Sabin. Medical statistics at a glance. Wiley-Blackwell 
PC or AV used in
(More Details) Lecture 1,3-6: Lecture using Slide and practice of JMP
Lecture 2,7-12: Lecture using Slide
Lecture 13-15: Group work 
Learning techniques to be incorporated  
Suggestions on
Preparation and
Active participation is required. 
Requirements Bring your PC.
Statistical soft is to be JMP(licensed in HU).
Last report is the application form of clinical trial or epidemiological study.
Please think about your theme.

Completing or taking the course "Exercises and Seminar on Medical Statistics Using Statistical Software (3T)" is recomended.  
Grading Method Attitude to Lecture,
Quiz after every lecture, 3 Reports(medical statistics, echics, research plan) 
Practical Experience  
Summary of Practical Experience and Class Contents based on it  
Message Basic exercises of Biostatistics (medical statistics).
Learn the basic terminology and clinical method used in clinical trials. 
Other Language
Handout of all lecture: Japanese and English (Both)
Explanation by lecturer: Lecture 2 (Japanese), Lecture 8,9,10(English), Lecture 1,3,4,5,6,7,11,12 (Japanese and English), Lecture 13-15 (Group work and presentation by student, therefore depend on student) 
Please fill in the class improvement questionnaire which is carried out on all classes.
Instructors will reflect on your feedback and utilize the information for improving their teaching. 
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