CLINICAL STUDY EVALUATION PROGRAMME COURSE DESCRIPTION

Code	Name of the Course Unit	Semester	In-Class Hours (T+P)	Credit	ECTS Credit
TTP206	CLINICAL STUDY EVALUATION	4	3	2	4

GENERAL INFORMATION
Language of Instruction :	Türkçe
Level of the Course Unit :	, TYY: + , EQF-LLL: , QF-EHEA:
Type of the Course :	Zorunlu
Mode of Delivery of the Course Unit	-
Coordinator of the Course Unit
Instructor(s) of the Course Unit
Course Prerequisite	No

OBJECTIVES AND CONTENTS
Objectives of the Course Unit:	Tıbbi ilaç ve tıbbi cihazların klinik saha çalışmalarının yapılmasında, değerlendirilmesinde yapılacak uygulamaların genel durumunu belirtmeyi amaçlamaktadır.
Contents of the Course Unit:	Klinik çalışma, tıbbi cihazın amaçlanan kullanımı ve klinik çalışma planı”na uygun olarak yapılması gerekenleri içermektedir.

KEY LEARNING OUTCOMES OF THE COURSE UNIT (On successful completion of this course unit, students/learners will or will be able to)
Klinik araştırmanın protokol, diğer mevzuata uygun biçimde yürütülmesini amaçlar.
Kalite güvencesi ve kalite kontrol sistemlerinin bulunmasını ve uygulanmasını sağlamak üzere Standart Çalışma Yöntemlerinin belirlenmesinden ve araştırmanın dahili denetiminin yürütülmesini sağlamaktadır.

WEEKLY COURSE CONTENTS AND STUDY MATERIALS FOR PRELIMINARY & FURTHER STUDY
Week	Preparatory	Topics(Subjects)	Method
1	Literatür Tarama	Klinik Çalışma ve Değerlendirmeye Giriş	Yüz Yüze Eğitim
2	Literatür Tarama	Araştırmanın Yürütülmesi ile İlgili Sorumlulukları	Yüz Yüze Eğitim
3	Literatür Tarama	Araştırma Ürünü ile İlgili Sorumlulukları	Yüz Yüze Eğitim
4	Literatür Tarama	Veriler ve Kayıtlarla İlgili Sorumlulukları	Yüz Yüze Eğitim
5	Literatür Tarama	Sözleşmeli Araştırma Kuruluşu ile İlgili Sorumlulukları	Yüz Yüze Eğitim
6	Literatür Tarama	Klinik İlaç Araştırmalarında Monitorizasyon (İzleme)	Yüz Yüze Eğitim
7	Literatür Tarama	İzleyicilerin Seçimi ve Özellikleri	Yüz Yüze Eğitim
8	-	ARA SINAV	-
9	Literatür Tarama	Klinik İlaç Araştırmalarında Kalite Kontrolü ve Kalite Güvencesi	Yüz Yüze Eğitim
10	Literatür Tarama	Klinik İlaç Araştırmalarının Neden Olduğu Zararların Karşılanması	Yüz Yüze Eğitim
11	Literatür Tarama	Biyoetik Kurullarının Yapılanma Sürecine Bakış	Yüz Yüze Eğitim
12	Literatür Tarama	Avrupa Konseyi ve İnsanlar Üzerindeki Tıbbi Araştırmalar	Yüz Yüze Eğitim
13	Literatür Tarama	Klinik Araştırma Etik Kurullarının Görevleri ve İşleyişi	Yüz Yüze Eğitim
14	Literatür Tarama	Öğrenci Sunumları - Soru Cevap	Yüz Yüze Eğitim
15	-	Genel Tekrar	Yüz Yüze Eğitim
16	-	FİNAL	-
17	-	FİNAL	-

SOURCE MATERIALS & RECOMMENDED READING

ASSESSMENT
Assessment & Grading of In-Term Activities	Number of Activities	Degree of Contribution (%)	Description

Level of Contribution
0	1	2	3	4	5

KNOWLEDGE
Theoretical
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	To follow and comprehend the legal regulations, professional standards and practices in the field						5
2	To be able to use basic knowledge and skills related to the field, to interpret and evaluate the data and to realize the problems that may occur and to propose solutions.					4
3	To be able to access, evaluate and apply scientific knowledge in line with theoretical and practical knowledge acquired in the field.	0
4	To be able to work on basic level projects related to the field, to take responsibility individually and in team work and to solve problems.						5
5	To be able to make health, safety and risk assessment related to the field and to take precautions against dangers.					4

KNOWLEDGE
Factual
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Identify problems related to the field, produce and present solutions.					4
2	To improve the professional knowledge and skills of the team and to evaluate the performances objectively.	0
3	To be able to manage technical and professional activities related to the field in complex and unforeseen situations.						5
4	To take responsibility as a team member.						5
5	To be able to use information related to the field in business environment and profession.	0
6	To have basic knowledge about the concepts and principles related to the field.						5
7	To be able to legalize the works in the field and to perform within the professional standards.					4

SKILLS
Cognitive
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Uses basic theoretical and practical knowledge related to the field, basic computer programs and related technologies.					4
2	Know and apply document management in the field	0
3	Has knowledge of computer programs, has knowledge of keyboard techniques effectively uses						5

SKILLS
Practical
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Has the ability to use the knowledge acquired in the field of business administration and management in decisions, practices and behaviors.	0
2	Has the ability to analyze, interpret and evaluate the information related to the field.	0
3	Interprets and evaluates data by using the basic knowledge and skills acquired in the field of health, identifies, analyzes and takes part in studies planned for solution.					4

OCCUPATIONAL
Autonomy & Responsibility
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Carries out a given task independently by using his / her basic knowledge in the field of health.						5
2	Work as a team member to solve complex and unpredictable problems encountered in health-related practices.	0
3	Manages the activities for the development of the employees under the responsibility of a project.					4
4	Acts in accordance with the laws, regulations, legislation and professional ethics rules related to her duties, rights and responsibilities as an individual.						5
5	In the field of Medical Promotion and Marketing, it monitors the events on the agenda of the society and the world and is sensitive to developments.						5

OCCUPATIONAL
Learning to Learn
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Evaluates the basic knowledge and skills acquired in the field of health with a critical approach.						5
2	Identify learning needs and guide learning.	0
3	Has the awareness of lifelong learning.	0

OCCUPATIONAL
Communication & Social
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Informs the related persons and institutions by using the basic knowledge and skills in the field of health, transfers their thoughts and solutions to problems in written and verbal form.					4
2	He / She shares his / her ideas and solutions for problems related to the field of health with experts and non-experts.	0
3	Contributes to projects and activities for the social environment in which he lives with the awareness of social responsibility.						5
4	Contributes to projects and activities for the social environment in which he lives with the awareness of social responsibility.	0
5	Uses information and communication technologies together with computer software at a basic level of at least European Computer Driving License required by the field.					4

OCCUPATIONAL
Occupational and/or Vocational
	Programme Learning Outcomes	Level of Contribution
		0	1	2	3	4	5
1	Acts in accordance with social, scientific, cultural and ethical values in the stages of collecting, interpreting, applying and announcing the results related to the field of health.						5
2	Acts in accordance with quality management and processes and participates in these processes.						5
3	Has sufficient awareness about individual and public health, environmental protection and occupational safety.					4
4	Acts in accordance with the laws, regulations, legislation and professional ethics rules related to her duties, rights and responsibilities as an individual.					4
5	Has experience of working with other health disciplines.						5

WORKLOAD & ECTS CREDITS OF THE COURSE UNIT
Workload for Learning & Teaching Activities
Type of the Learning Activites	Learning Activities (# of week)	Duration (hours, h)	Workload (h)
Ders	14	3	42
Derse Ön Hazırlık ve Ders Sonrası Pekiştirme	0	0	0
Arazi Çalışması	0	0	0
Grup Çalışması / Ödevi	1	1	1
Laboratuvar	0	0	0
Okuma	2	2	4
Ödev	2	1	2
Proje Hazırlama	0	0	0
Seminer	0	0	0
Staj	0	0	0
Teknik Gezi	0	0	0
Web Tab. Öğrenme	0	0	0
Uygulama	0	0	0
Yerinde Uygulama	0	0	0
Mesleki Faaliyet	0	0	0
Sosyal Faaliyet	0	0	0
Tez Hazırlama	0	0	0
Alan Çalışması	0	0	0
Rapor Yazma	0	0	0
Final Sınavı	1	1	1
Final Sınavı Hazırlığı	4	5	20
Ara Sınav	4	5	20
Ara Sınav Hazırlığı	3	2	6
Kısa Sınav	0	0	0
Kısa Sınav Hazırlığı	0	0	0
TOPLAM	31	0	96