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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

CONTRIBUTION OF THE COURSE UNIT TO THE PROGRAMME LEARNING OUTCOMES

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
Total Workload of the Course Unit 96
Workload (h) / 25.5 3,8
ECTS Credits allocated for the Course Unit 4,0