Dokuz Eylül University Information Package / Courses Catalog

Description of Individual Course Units

Course Unit Code	Course Unit Title	Type Of Course	D	U	L	ECTS
KIA 5005	CLINICAL TRIALS I	COMPULSORY	2	2	0	12

Offered By

CLINICAL DRUG RESEARCH

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR MUKADDES GÜMÜŞTEKIN

Offered to

CLINICAL DRUG RESEARCH
TRANSLATIONAL MEDICINE

Course Objective

To evaluate practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines

Learning Outcomes of the Course Unit

1	to know and to be able to implement the national and international regulations in conducting clinical trials
2	to know and to be able to implement clinical trial design
3	to know and to be able to implement the fundamental biostatistical concepts in clinical trials
4	to be able to write clinical trial protocol synopsis
5	to know the responsibilities of clinical trial s parties

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week	Subject	Description
1	General concepts of Clinical Trials
2	Planning clnical trials (control group selection, randomisation, placebo use, inclusion/exclusion criterias)
3	Planning in clinical trials/incorrect planning results (control group selection, randomisation, placebo use, inclusion/exclusion criterias)
4	Planning and design in clinical trials I (Experimental studies, parallel design trials, cross pass trials, factorial trial design, consecutive design trials )
5	Planning and design in clinical trials II (observational studies: cohort studies, case-control studies, cross-sectional studies)
6	The aim of the clinical trials, hypotesis, measurement scales, endpoints, surragate endpoints
7	Fundemental biostatistical concepts in clinical trials I
8	Descriptive statistic
9	Parametric, nonparametric analysis selection
10	Parametric, nonparametric analysis selection
11	Estimating sample size in clinical trials
12	Survival analysis
13	Preperation of Clinical Trial protocol summary
14	Preperation of Clinical Trial protocol summary

Recomended or Required Reading

Textbook(s)/References/Materials:
Clinical Trials Handbook : Design and Conduct. Meinert, Curtis L. 2012. http://site.ebrary.com/lib/deulibrary/detail.action docID=10608725
Fundamentals of Clinical Trial. Friedman LM, Furberg CD, DeMets DL. 2010. http://link.springer.com/book/10.1007%2F978-1-4419-1586-3

Yerli kaynaklar :
Klinik Farmakolojinin Esasları ve Temel Düzenlemeler Prof Dr S O Kayaalp 5. Baskı, 2012
Klinik Araştırmalar Kitabı-2014 Editörler: Prof Dr H Akan, Dr H Ilbars, N Ömeroğlu Çetinkaya. Bilimsel Tıp Yayınevi, Ankara, 2014.

Planned Learning Activities and Teaching Methods

All the strategies are located Assesment methods and Total work load

Assessment Methods

SORTING NUMBER	SHORT CODE	LONG CODE	FORMULA
1	PRF	PERFORMANCE
2	FIN	FINAL EXAM
3	FCG	FINAL COURSE GRADE	PRF * 0.40 + FIN*0.60
4	RST	RESIT
5	FCGR	FINAL COURSE GRADE (RESIT)	PRF * 0.40 + FCGR*0.60

*** Resit Exam is Not Administered in Institutions Where Resit is not Applicable.

Further Notes About Assessment Methods

None

Assessment Criteria

To be succesful in final exam and, to present a topic in course outline as a homework

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

gumustekinm@gmail.com, Tel: 4123906

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities	Number	Time (hours)	Total Work Load (hours)
Lectures	14	2	28
Practice (Reflection)	14	2	28
Preparations before/after weekly lectures	14	9	126
Preparation for final exam	1	40	40
Preparing assignments	14	6	84
Final	1	2	2
TOTAL WORKLOAD (hours)			308

Contribution of Learning Outcomes to Programme Outcomes

PO/LO	PO.1	PO.2	PO.3	PO.4	PO.5	PO.6	PO.7	PO.8	PO.9	PO.10
LO.1	5	5	4	2	5	4	2	3	4	3
LO.2	5	5	5	3	3	4	3	3	3	3
LO.3	5	3	4	5	3	3	3	2	3	2
LO.4	5	5	5	5	5	3	2	5	2	3
LO.5	5	5	4	2	5	3	2	5	2	3

COURSE UNIT TITLE

DEGREE PROGRAMMES

Description of Individual Course Units

Offered By

Level of Course Unit

Course Coordinator

Offered to

Course Objective

Learning Outcomes of the Course Unit

Mode of Delivery

Prerequisites and Co-requisites

Recomended Optional Programme Components

Course Contents

Recomended or Required Reading

Planned Learning Activities and Teaching Methods

Assessment Methods

Further Notes About Assessment Methods

Assessment Criteria

Language of Instruction

Course Policies and Rules

Contact Details for the Lecturer(s)

Office Hours

Work Placement(s)

Workload Calculation

Contribution of Learning Outcomes to Programme Outcomes

CONTACT INFORMATION