TB910003 Basic and Advanced Training on Methodology for Clinical Research

Hiroshima University Syllabus

Japanese

Academic Year 2022Year School/Graduate School Graduate School of Biomedical and Health Sciences (Doctoral Course)

Lecture Code TB910003 Subject Classification Specialized Education

Subject Name 臨床研究の基礎および実践

Subject Name
（Katakana）リンショウケンキュウノキソオヨビジッセン

Subject Name in
English Basic and Advanced Training on Methodology for Clinical Research

Instructor TANAKA JUNKO,NISHIKAWA MASAKO,KONO YOICHI,FUKUMA SHINGO,YOSHIMURA KENICHI,NAGASHIMA SHINTARO,KO KO,AKITA TOMOYUKI,SUGIYAMA AYA

Instructor
(Katakana) 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,ヨシムラ　ケンイチ,ナガシマ　シンタロウ,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
In principle, Lecture 1-12 will be conducted face-to-face.
Lecture 13-15, group work (face-to-face or online:teams)

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
Program
Criterion referenced
Evaluation

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 (10/4) Basic biostatistics I (Tomoyuki Akita/ Junko Tanaka)
（face-to-face）
Lesson 2 (10/11) Basic biostatistics II (Tomoyuki Akita)（face-to-face）
Lesson 3 (10/18) Basic biostatistics III (Kenichi Yoshimura)（on-demand）　
Lesson 4 (10/25) Practice in Data analysis (Tomoyuki Akita/Shintaro Nagashima)（face-to-face）
Lesson 5 (11/8) Topics in Epidemiology & Biostatistics (Tomoyuki Akita)（face-to-face）
Lesson 6 (11/15) Medical research and drug development (Yoichi Kohno)（face-to-face）　
Lesson 7 (11/22) Designing Clinical Research Project (Shingo Fukuma)（face-to-face）
Lesson 8 (12/29) Basic observational study (Ko Ko)（face-to-face）
Lesson 9 (12/6) Basic clinical trials (Masako Nishikawa)（on-demand）　
Lesson 10 (12/13) Planning of clinical trials I (Masako Nishikawa)（on-demand）
Lesson 11 (12/20) Planning of clinical trials Ⅱ (Tomoyuki Akita)（face-to-face）
Lesson 12 (1/10) Ethical guidelines for clinical research (Shintaro Nagashima/Tomoyuki Akita)（e-learning）
Lesson 13 (1/17) Practice in protocol of clinical trial and epidemiological study, Part 1(Kenichi Yoshimura/ Natsuko Tamura/ Ko Ko/Tomoyuki Akita)（face-to-face or Teams）
Lesson 14 (1/24) Practice in protocol of clinical trial and epidemiological study, Part 2(Kenichi Yoshimura/ Natsuko Tamura/ Ko Ko/ Tomoyuki Akita)（face-to-face or Teams）
Lesson 15 (1/31) Presentation of protocol of clinical trial and epidemiological study(Kenichi Yoshimura/ Natsuko Tamura/ Ko Ko/ Tomoyuki Akita)（face-to-face or Teams）

3 times reports and final presentation

Text/Reference
Books,etc. Handout,
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
Class,etc. 　

(More Details) Lecture 1-5: Lecture using Slide and practice of JMP
Lecture 6-12: Lecture using Slide
Lecture 13-15: Group work

Learning techniques to be incorporated 　

Suggestions on
Preparation and
Review 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.

Before starting the lecture, please visit the following website, and submit application form of JMP (campus license) and get it.
https://cimr.hiroshima-u.ac.jp/rinsho/jmp

Completing or taking the course "Exercises and Seminar on Medical Statistics Using Statistical Software (3T)" is recommended.

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 6 (Japanese), Lecture 8,9,10(English), Lecture 1,2,3,4,5,7,11,12 (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.

Academic Year	2022Year	School/Graduate School	Graduate School of Biomedical and Health Sciences (Doctoral Course)
Lecture Code	TB910003	Subject Classification	Specialized Education
Subject Name	臨床研究の基礎および実践
Subject Name （Katakana）	リンショウケンキュウノキソオヨビジッセン
Subject Name in English	Basic and Advanced Training on Methodology for Clinical Research
Instructor	TANAKA JUNKO,NISHIKAWA MASAKO,KONO YOICHI,FUKUMA SHINGO,YOSHIMURA KENICHI,NAGASHIMA SHINTARO,KO KO,AKITA TOMOYUKI,SUGIYAMA AYA
Instructor (Katakana)	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,ヨシムラ　ケンイチ,ナガシマ　シンタロウ,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 In principle, Lecture 1-12 will be conducted face-to-face. Lecture 13-15, group work (face-to-face or online:teams)
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 Program
Criterion referenced Evaluation
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 (10/4) Basic biostatistics I (Tomoyuki Akita/ Junko Tanaka) （face-to-face） Lesson 2 (10/11) Basic biostatistics II (Tomoyuki Akita)（face-to-face） Lesson 3 (10/18) Basic biostatistics III (Kenichi Yoshimura)（on-demand）　 Lesson 4 (10/25) Practice in Data analysis (Tomoyuki Akita/Shintaro Nagashima)（face-to-face） Lesson 5 (11/8) Topics in Epidemiology & Biostatistics (Tomoyuki Akita)（face-to-face） Lesson 6 (11/15) Medical research and drug development (Yoichi Kohno)（face-to-face）　 Lesson 7 (11/22) Designing Clinical Research Project (Shingo Fukuma)（face-to-face） Lesson 8 (12/29) Basic observational study (Ko Ko)（face-to-face） Lesson 9 (12/6) Basic clinical trials (Masako Nishikawa)（on-demand）　 Lesson 10 (12/13) Planning of clinical trials I (Masako Nishikawa)（on-demand） Lesson 11 (12/20) Planning of clinical trials Ⅱ (Tomoyuki Akita)（face-to-face） Lesson 12 (1/10) Ethical guidelines for clinical research (Shintaro Nagashima/Tomoyuki Akita)（e-learning） Lesson 13 (1/17) Practice in protocol of clinical trial and epidemiological study, Part 1(Kenichi Yoshimura/ Natsuko Tamura/ Ko Ko/Tomoyuki Akita)（face-to-face or Teams） Lesson 14 (1/24) Practice in protocol of clinical trial and epidemiological study, Part 2(Kenichi Yoshimura/ Natsuko Tamura/ Ko Ko/ Tomoyuki Akita)（face-to-face or Teams） Lesson 15 (1/31) Presentation of protocol of clinical trial and epidemiological study(Kenichi Yoshimura/ Natsuko Tamura/ Ko Ko/ Tomoyuki Akita)（face-to-face or Teams） 3 times reports and final presentation
Text/Reference Books,etc.	Handout, 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 Class,etc.
(More Details)	Lecture 1-5: Lecture using Slide and practice of JMP Lecture 6-12: Lecture using Slide Lecture 13-15: Group work
Learning techniques to be incorporated
Suggestions on Preparation and Review	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. Before starting the lecture, please visit the following website, and submit application form of JMP (campus license) and get it. https://cimr.hiroshima-u.ac.jp/rinsho/jmp Completing or taking the course "Exercises and Seminar on Medical Statistics Using Statistical Software (3T)" is recommended.
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 6 (Japanese), Lecture 8,9,10(English), Lecture 1,2,3,4,5,7,11,12 (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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