COURSE UNIT TITLE

: TRANSLATIONAL RESEARCH AND PHASE STUDIES

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
TRO 5009 TRANSLATIONAL RESEARCH AND PHASE STUDIES ELECTIVE 3 0 0 6

Offered By

Translational Oncology

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR HÜLYA ELLIDOKUZ

Offered to

Translational Oncology
Translational Oncology

Course Objective

The purpose of this course, translational clinical research is to learn the principles of ethics and management.
In this course, the creation of translational research questions, translational research design issues: masking, randomization, protocol preparation, study eligibility and the final evaluation criteria, responsibilities of translational research investigator's, pre-clinical to translational, clinical research ethics and history, Phase 1 clinical trials, Phase 2 clinical trials, Phase 3 clinical trials, Phase 4 clinical trials, equivalence studies, the sponsor's responsibilities in clinical research, monitoring and analysis of special topics in clinical research, the presentation and reporting in translational research will be discussed.

Learning Outcomes of the Course Unit

1   Be able to defines research questions in translational research.
2   Be able to know the translational research design.
3   Recognize and understand the clinical trials and phase study
4   Be able to know ethical principles in clinical research
5   Be able to know of the responsibility of investigator, and the sponsor.
6   Recognize and understand the research presentation and reporting.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 The creation of translational research question 1
2 The creation of translational research question 2
3 Design issues in translational research: masking, randomization, protocol preparation, study eligibility criteria and final evaluations
4 Clinical Validation
5 The responsibilities of researchers in translational research
6 The translation to preclinical study
7 Ethics and history in clinical research
8 Phase 1 clinical trials
9 Phase 2 clinical trials
10 Phase 3 clinical trials
11 Phase 4 clinical trials
12 Equivalence studies
13 The sponsor's responsibility In clinical trials and monitoring
14 Special topics in clinical trials about analysis
15 Translational research presentation and reporting.

Recomended or Required Reading

Molecular Biology of the Cell, 6th Edition. Ed. Bruce Alberts, Alexander Johnson, Julian Lewis, Martin Raff, Keith Roberts, Peter Walter. Garland Publishers
Essential Cell Biology - 4th Edition Bruce Alberts, Dennis Bray, Karen Hopkin, Alexander D Johnson, Julian Lewis, Martin Raff, Keith Roberts, Peter Walter Garland Publishers
The Biology of Cancer, 2nd Edition, Robert A. Weinberg, Garland Publishers
Molecular Biology of the Gene, 7th edition, James Watson, Alexander Gann, Tania Baker, Michael Levine, Stephan Bell, Richard Losick, Stephan Harrison Pearson Cold Spring harbor Laboratory Press.
Principles of Molecular Diagnostics and Personalized Cancer Medicine, Dongfeng Tan, henry Lynch, Wolters Kluwer, Lippincott Williams&Wilkins.
The Handbook of Biomarkers, Kewal Jain, Humana Press
Translational and Experimental Clinical Research, Daniel Schuster, William Powers, Lippincott Williams&Wilkins.

Planned Learning Activities and Teaching Methods

Lectures, the topics with classroom activities (presentations and homework assignments) to consolidate and discussion

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 MTE MIDTERM EXAM
2 PRF PERFORMANCE
3 FIN FINAL EXAM
4 FCG FINAL COURSE GRADE MTE * 0.20 +PRF * 0.20 + FIN* 0.60
5 RST RESIT
6 FCGR FINAL COURSE GRADE MTE * 0.20 +PRF * 0.20 +RST* 0.60


Further Notes About Assessment Methods

None

Assessment Criteria

1. The learner will clearly define outlined LO1, LO2, LO3, which will evaluate with exam.
2. The learner will recognize, LO4, LO5, LO6 will evaluate with homework, prepared presentations by themselves and exam.

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

hülya.ellidokuz@deu.edu.tr ; 0 232 412 58 01

Office Hours

Monday 11:00-12:00

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 15 3 45
Preparations before/after weekly lectures 15 3 45
Preparation for midterm exam 1 8 8
Preparation for final exam 1 10 10
Preparing assignments 4 5 20
Preparing presentations 2 10 20
Final 1 1 1
Midterm 1 1 1
TOTAL WORKLOAD (hours) 150

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10PO.11PO.12
LO.155555
LO.255555
LO.355555
LO.455555
LO.555555
LO.6555555

CONTACT INFORMATION
Dokuz Eylül Üniversitesi Cumhuriyet Bulvarı No: 144 35210 Alsancak / İZMİR
Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

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