GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
GOOD CLINICAL PRACTICE AND SCIENTIFIC ETHICS/TFRL-5130
Course Title: GOOD CLINICAL PRACTICE AND SCIENTIFIC ETHICS
Credits 3 ECTS 9
Course Semester 3 Type of The Course Compulsory
COURSE INFORMATION
 -- (CATALOG CONTENT)
 -- (TEXTBOOK)
 -- (SUPPLEMENTARY TEXTBOOK)
 -- (PREREQUISITES AND CO-REQUISITES)
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- COURSE OBJECTIVES
 -- COURSE LEARNING OUTCOMES
To be able to define preclinical and clinical research processes on the way from molecule to drug and to evaluate scientific, economic and legal steps.
To be able to explain ethical concepts and principles in clinical research and to interpret ethical problems
To comprehend the content of national and international regulations
Describe the role and responsibility of a pharmacologist in a clinical trial
To be able to prepare a clinical research project and submit it to the "Clinical Research Ethics Committee" with all annexes (Informed consent form, case report form ...)
To be able to evaluate a scientific clinical research project within the discipline of pharmacology from an ethical and scientific point of view

 -- MODE OF DELIVERY
  The mode of delivery of this course is Face to face
 --WEEKLY SCHEDULE
1. Week  Clinical research of medicinal products for human use (Phase 1,2,3,4)
2. Week  GCP Guidline
3. Week  GCP Guidline
4. Week  GCP Guidline
5. Week  Clinical research terminology practive
6. Week  Declaration of Helsinki
7. Week  Volunteers and ethics, IC (Informed consent form)
8. Week  Ministry of Health, Regulation on Clinical Trials
9. Week  Ministry of Health, Regulation on Clinical Trials
10. Week  Bioavailability / bioequivalence studies Observational drug studies
11. Week  Clinical investigations of health declaration products
12. Week  Informed concent
13. Week  Discussion of the application file of the ethics committee
14. Week  Evaluation of the application file of the ethics committee and exam
15. Week  
16. Week  
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
0
0
 Assignment
0
0
 Application
20
0
 Projects
40
0
 Practice
0
0
 Quiz
0
0
 Percent of In-term Studies  
60
 Percentage of Final Exam to Total Score  
40
 -- WORKLOAD
 Activity  Total Number of Weeks  Duration (weekly hour)  Total Period Work Load
 Weekly Theoretical Course Hours
14
3
42
 Weekly Tutorial Hours
0
 Reading Tasks
10
3
30
 Searching in Internet and Library
10
2
20
 Material Design and Implementation
6
4
24
 Report Preparing
10
4
40
 Preparing a Presentation
6
4
24
 Presentation
6
3
18
 Midterm Exam and Preperation for Midterm Exam
0
 Final Exam and Preperation for Final Exam
5
3
15
 Other (should be emphasized)
6
2
12
 TOTAL WORKLOAD: 
225
 TOTAL WORKLOAD / 25: 
9
 Course Credit (ECTS): 
9
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1
2X
3X
4X
5
6X
7X
8X
9X
10
11X
12X
13X
14X
 -- NAME OF LECTURER(S)
   (ALL FACULTY OF MEDICINE PHARMACOLOGY)
 -- WEB SITE(S) OF LECTURER(S)
   ()
 -- EMAIL(S) OF LECTURER(S)
   (culuoglu@yahoo.com cimenkrs@gmail.com zaferguney@yahoo.com sbarun99@hotmail.com edilekoz@gmail.com soilhan@Hotmail.com gokcesevimozturk@hotmail.com )