COURSE UNIT TITLE

: CLINICAL TRIALS IN CANCER RESEARCH

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
OKE 5009 CLINICAL TRIALS IN CANCER RESEARCH ELECTIVE 3 0 0 6

Offered By

CANCER APIDEMIOLOGY

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR HÜLYA ELLIDOKUZ

Offered to

Canser Epidemiology
CANCER APIDEMIOLOGY

Course Objective

ethics and history In clinical research, Phase 1 clinical trials, Phase 2 clinical trials, Phase 3 clinical trials, Phase 4 clinical trials, clinical trial design issues: sample size, clinical trial design issues: masking, randomization, protocol preparation in clinical research, suitability of study and final assessment criteria, the sponsor's responsibilities In clinical trials, monitoring In clinical trials, audit In clinical trials, Special topics in analysis of clinical research: PP, ITT, Special topics topics in analysis of clinical research: safety analysis, presentation and reporting in clinical trials.

Learning Outcomes of the Course Unit

1   Acquire basic epidemiology, clinical and genetic cancer epidemiology knowledge and ability to practice of the epidemiological techniques.
2   Be able to understand cancer epidemiology at the molecular level.
3   Be able to use evidence in their practices
4   Acquire level of foreign language knowledge in the literature has followed
5   Be able to prepare studies and appropriate informed consent is the field of epidemiology and oncology
6   Capable of studies involving different disciplines makes the group work.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Ethics and history in clinical research
2 Phase 1 clinical trials
3 Phase 2 clinical trials
4 Phase 3 clinical trials
5 Phase 4 clinical research
6 Design issues in clinical research: sample size
7 design issues In a clinical trial: masking, randomization
8 protocol preparation In clinical trials, suitability of study and final assessment criteria
9 The responsibilities of investigators in clinical research
10 the sponsor's responsibilities In clinical trials
11 Monitoring in clinical research
12 audit In clinical trials
13 Special topics in analysis of clinical research: PP, ITT
14 Special topics in analysis of clinical research: safety analysis
15 Presentation and reporting in clinical research
16 General evaluation

Recomended or Required Reading

1.Cancer Epidemiyology Principles and Methods.(Internationel Agency for Research on Cancer) WHO
2.Textbook of Cancer Epidemiyology (Hans-Abu Ademi, David Hunter, Dimitrios Trichopoulor) 2002, Oxford University.
3. Sağlıkta Araştırma Teknikleri ve Analiz Yöntemleri (Prof.Dr.Gazanfer Aksakoğlu)

Planned Learning Activities and Teaching Methods

Theoretical Lectures, the topics in-class activities (presentations and assignments) to consolidate and discussion and home work

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 which will evaluate with exam and homework.

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

To be announced.

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 16 2 32
Tutorials 16 2 32
Preparations before/after weekly lectures 15 1 15
Preparation for midterm exam 1 10 10
Preparation for final exam 1 19 19
Preparing assignments 10 4 40
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.9
LO.15
LO.25
LO.35
LO.45
LO.55
LO.65