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 :	Turkish
Level of the Course Unit :	, TYY: + , EQF-LLL: , QF-EHEA:
Type of the Course :	Compulsory
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:	The aim of this course is to state the general status of the applications to be made and evaluated in clinical field studies of medical drugs and medical devices.
Contents of the Course Unit:	The clinical study includes the intended use of the medical device and what needs to be done in accordance with the clinical study plan.

KEY LEARNING OUTCOMES OF THE COURSE UNIT (On successful completion of this course unit, students/learners will or will be able to)
It aims to conduct clinical research in accordance with the protocol and other legislation.
It ensures the identification of Standard Working Methods and conducting internal audit of the research to ensure that quality assurance and quality control systems are available and implemented.

WEEKLY COURSE CONTENTS AND STUDY MATERIALS FOR PRELIMINARY & FURTHER STUDY
Week	Preparatory	Topics(Subjects)	Method
1	Literature Search	Introduction to Clinical Study and Evaluation	Face to Face
2	Literature Search	Responsibilities for conducting the research	Face to Face
3	Literature Search	Responsibilities of Research Product	Face to Face
4	Literature Search	Responsibilities Regarding Data and Records	Face to Face
5	Literature Search	Responsibilities of Contract Research Organization	Face to Face
6	Literature Search	Monitoring in Clinical Drug Research	Face to Face
7	Literature Search	Audience Selection and Characteristics	Face to Face
8	-	MID-TERM EXAM	-
9	Literature Search	Quality Control and Quality Assurance in Clinical Drug Research	Face to Face
10	Literature Search	Coverage of Damages Caused by Clinical Drug Research	Face to Face
11	Literature Search	Overview of the Structure of Bioethics Committees	Face to Face
12	Literature Search	Council of Europe and Medical Research on People	Face to Face
13	Literature Search	Duties and Functioning of Clinical Research Ethics Committees	Face to Face
14	Literature Search	Student Presentations - Question and Answer	Face to Face
15	Literature Search	An overview	Face to Face
16	-	FINAL EXAM	-
17	-	FINAL EXAM	-

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)
Lecture & In-Class Activities	14	3	42
Preliminary & Further Study	0	0	0
Land Surveying	0	0	0
Group Work	1	1	1
Laboratory	0	0	0
Reading	2	2	4
Assignment (Homework)	2	1	2
Project Work	0	0	0
Seminar	0	0	0
Internship	0	0	0
Technical Visit	0	0	0
Web Based Learning	0	0	0
Implementation/Application/Practice	0	0	0
Practice at a workplace	0	0	0
Occupational Activity	0	0	0
Social Activity	0	0	0
Thesis Work	0	0	0
Field Study	0	0	0
Report Writing	0	0	0
Final Exam	1	1	1
Preparation for the Final Exam	4	5	20
Mid-Term Exam	4	5	20
Preparation for the Mid-Term Exam	3	2	6
Short Exam	0	0	0
Preparation for the Short Exam	0	0	0
TOTAL	31	0	96