COURSE UNIT TITLE

: PARTIES IN CLINICAL RESEARCH

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
KIA 5007 PARTIES IN CLINICAL RESEARCH COMPULSORY 2 2 0 12

Offered By

CLINICAL DRUG RESEARCH

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR AYŞE GELAL

Offered to

CLINICAL DRUG RESEARCH

Course Objective

To discuss the history of regulations related with ethical issues in clinical trials; to discuss the overview of clinical trials in Türkiye and in the world; to discuss the duty and responsibilities of ethical committees; to discuss the duty and responsibilities of researchers; to discuss the protection of volunteers and the responsibilities of sponsors, to discuss the duty and responsibilities of CROs.

Learning Outcomes of the Course Unit

1   to know and to be able to implement the international regulations in conducting clinical
2   to know and to be able to implement the national regulations in conducting clinical trials
3   to know and to evaluate the responsibilities of clinical trial s parties (investigator, sponsor, ethics committees)
4   to know and to be able to how to protect volunteers in clinical trials
5   to know and to be able to conduct the process of informed consent in clinical trials

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 International regulations in clinical trials
2 National regulations in clinical trials
3 The importance of clinical trials and the problems in our country
4 Ethics committees and evaluation of clinical trial applications
5 Non-interventional ethics committees and evaluation of clinical trial applications
6 The role of investigator in clinical trials
7 Protection of study subjects, obtaining informed consent
8 Advers event reportin in clinical trials
9 Quality management in clinical trials
10 The role of sponsor in clinical trials
11 The role of CRO in clinical trials
12 Auditing in clinical trials
13 Compassionate use programme
14 Presentation of homeworks

Recomended or Required Reading

Textbook(s):
1. Concise Guide to Clinical Trials. Hackshaw AK. 2009. (DEÜ Kütüphanesi) http://site.ebrary.com/lib/deulibrary/reader.action docID=10308186
2. Clinical Trials Handbook : Design and Conduct. Meinert, Curtis L. 2012. (DEÜ Kütüphanesi) http://site.ebrary.com/lib/deulibrary/detail.action docID=10608725
3. Fundamentals of Clinical Trial. Friedman LM, Furberg CD, DeMets DL. 2010. (DEÜ Kütüphanesi) http://link.springer.com/book/10.1007%2F978-1-4419-1586-3

Planned Learning Activities and Teaching Methods

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 PRF PERFORMANCE
2 FIN FINAL EXAM
3 FCG FINAL COURSE GRADE PRF * 0.40 + FIN*0.60
4 RST RESIT
5 FCGR FINAL COURSE GRADE (RESIT) PRF * 0.40 + FCGR*0.60


Further Notes About Assessment Methods

None

Assessment Criteria

To be succesful in final exam and, to present a topic in course outline as a homework

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

ayse.gelal@deu.edu.tr, Tel: 4123904

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 2 28
Tutorials 14 2 28
Preparations before/after weekly lectures 14 9 126
Preparation for final exam 1 40 40
Preparing assignments 14 5 70
Final 1 2 2
TOTAL WORKLOAD (hours) 294

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10
LO.15553542543
LO.25553543533
LO.35553533522
LO.45553532522
LO.55552532522

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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