1	Course Title:	CLINICAL TRIALS
2	Course Code:	TBY 6008
3	Type of Course:	Compulsory
4	Level of Course:	Third Cycle
5	Year of Study:	1
6	Semester:	1
7	ECTS Credits Allocated:	3
8	Theoretical (hour/week):	2
9	Practice (hour/week) :	0
10	Laboratory (hour/week) :	0
11	Prerequisites:	None
12	Recommended optional programme components:	None
13	Language:	Turkish
14	Mode of Delivery:	Face to face
15	Course Coordinator:	Prof. Dr. İLKER ERCAN
16	Course Lecturers:	Prof. Dr. İ. ERCAN
17	Contactinformation of the Course Coordinator:	Prof. Dr. İ. ERCAN ercan@uludag.edu.tr 2953888 Uludağ Üniversity, Faculty of Medicine, Department of Biostatistics, 16059, Nilüfer, BURSA
18	Website:	http://saglikbilimleri.uludag.edu.tr/anabilimdallari.php
19	Objective of the Course:	To provide the learning of basic concepts of the clinical trials.
20	Contribution of the Course to Professional Development

21

Learning Outcomes:

1 To conduct a clinical trial.;

22	Course Content:

Week	Theoretical	Practical
1	Basic Statistical Concepts
2	Basic Design Considerations
3	Randomization and Blinding
4	Designs for Clinical Trials
5	Designs for Clinical Trials in Oncology
6	Classification of Clinical Trials
7	Analysis of Continuous Data
8	Analysis of Categorical Data
9	Censored Data and Interim Analysis
10	Sample Size Determination
11	Issues in Efficacy Evaluation
12	Safety Assessment
13	Preparation and Implementation of a Clinical Protocol
14	Clinical Data Management

23	Textbooks, References and/or Other Materials:	1-Ozkaya G, Ediz B, Ercan I. Two-Stage Phase II Trials and Sample Size For Different Designs. Turkiye Klinikleri Journal of Biostatistics, 2012;4(2):70-80.(in Turkish). 2-Shein-Chung C, Jen-Pei L, Design and Analysis of Clinical Trials Concepts and Methodologies , John Wiley&Sons Inc, 2004. 3-Piantadosi S, Clinical Trials A Methodologic Perspective, John Wiley&Sons Inc, 1997.
24	Assesment

TERM LEARNING ACTIVITIES	NUMBER	PERCENT
Midterm Exam	0	0
Quiz	0	0
Homeworks, Performances	0	0
Final Exam	1	100
Total	1	100
Contribution of Term (Year) Learning Activities to Success Grade		0
Contribution of Final Exam to Success Grade		100
Total		100
Measurement and Evaluation Techniques Used in the Course
Information

25

ECTS / WORK LOAD TABLE

Activites	NUMBER	TIME [Hour]	Total WorkLoad [Hour]
Theoretical	14	2	28
Practicals/Labs	0	0	0
Self Study and Preparation	0	0	0
Homeworks, Performances	0	0	0
Projects	0	0	0
Field Studies	0	0	0
Midtermexams	0	0	0
Others	14	4	56
Final Exams	1	5	5
Total WorkLoad			89
Total workload/ 30 hr			2,97
ECTS Credit of the Course			3

26	CONTRIBUTION OF LEARNING OUTCOMES TO PROGRAMME QUALIFICATIONS
PQ1 PQ2 PQ3 PQ4 PQ5 PQ6 PQ7 PQ8 PQ9 PQ10 PQ11 LO1 4 4 4 5 3 0 0 0 0 0 0

LO: Learning Objectives

PQ: Program Qualifications

Contribution Level:

1 Very Low

2 Low

3 Medium

4 High

5 Very High