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Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS KIA 5004 CLINICAL RESEARCH MANAGEMENT ELECTIVE 1 0 0 4

Offered By

CLINICAL DRUG RESEARCH

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR MUALLA AYLIN ARICI

Offered to

CLINICAL DRUG RESEARCH

Course Objective

To desing and conduct the clinical trials; to be able to implement data management in clinical trials; to be able to supervise drug safety in clinical trials

Learning Outcomes of the Course Unit

1   To know and to be able to implement the national and international regulations in conducting clinical trials 2   to know the responsibilities of participants in clinical trials 3   To know and to be able to implement data management in clinical trials 4   To be able to prepare case report forms 5   To be able to prepare case report forms 6   To be able to supervise drug safety 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 Good Clinical Practice for clinical trials, essential study documents 2 Getting started: organization, communication; trial registration 3 Multicenter trial protocol implementation: visit schedule, standard operating procedures 4 Clinical center and patient recruitment; randomization, allocation concealment 5 FDA regulations 6 IND applications, IRB interactions and HIPAA compliance 7 National regulations in clinical trials 8 Designing a trial database, data management, and case report forms 9 Masking procedures, study drug packaging and distribution 10 Clinical center performance 11 Assessing adherence to protocol: trial interventions and other study procedures 12 Clinical trial adverse event monitoring 13 Preparation of clinical trial protocol I 14 Preparation of clinical trial protocol II 15 Final evaluations

Recomended or Required Reading

Basic and Clinical Pharmacology. B.Katzung. Appleton & Lange. 13th ed. 2011. Clinical Pharmacology. PN Bennet, MJ Brown. 10th ed.2008. Principles of Clinical Pharmacology. AJ Atkinson. 2007 Klinik Farmakolojinin Esasları ve Temel Düzenlemeler Prof Dr S O Kayaalp 5. Baskı, 2012

Planned Learning Activities and Teaching Methods

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA 1 PRF PERFORMANCE 2 FCG FINAL COURSE GRADE PRF

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)

Dokuz Eylul University School of Medicine Department of Pharmacology

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours) Lectures 14 2 28 Preparations before/after weekly lectures 14 4 56 Preparing presentations 1 16 16 TOTAL WORKLOAD (hours) 100

Contribution of Learning Outcomes to Programme Outcomes

PO/LO PO.1 PO.2 PO.3 PO.4 PO.5 PO.6 PO.7 PO.8 PO.9 PO.10 LO.1 5 5 5 5 5 5 5 5 5 5 LO.2 5 5 5 5 5 5 5 5 5 5 LO.3 5 5 5 5 5 5 5 5 5 5 LO.4 5 5 5 3 5 5 3 5 5 5 LO.5 5 5 5 5 5 5 5 5 5 5 LO.6 5 5 5 5 5 5 5 5 5 5