The 3 rd Clinical Research Training Course

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Organized By:

Event Venue:

In Collaboration With: Diamond Sponsor Diamond

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The 3

rd

Clinical

Research

Training Course

Main Sponsors:

Registration Fee:

Registration: SAR3,750 Symposium Secretariat: Telephone: (+966) 11 462 2515 Mobile: (+966) 53 390 0411

E Mail: [email protected] For Registration Please Visit: www.slca-sts.com

07 - 08 February 2014

Radisson Blu, Jeddah, Saudi Arabia

11

CMEs Hour

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Executive

Committee

Ms. Hanan El Desouky

Administration Office for

Chairman of Oncology Department Ministry of National Guard Health Affairs King Abdul Aziz Medical City, Riyadh

Riyadh, Saudi Arabia

Prof. Abdul Rahman Jazieh, MD, MPH

Chairman, CRTC2014

Chairman, Saudi Lung Cancer Association Chairman, Oncology Department Professor, King Saud University for Health Sciences

National Guards Health Affairs

Sami Khatib, MD

Co-Chairman, CRTC2014 Secretary General of AMAAC

(Arab Medical Association Against Cancer)

Amman, Jordan

Adda Bounedjar, MD

Algeria Hassan S. Alorainy, BsRC, RRT, FAARCExecutive Director, CRTC2014 Senior Clinical Respiratory Specialist

King Faisal Specialist Hospital and Research Centre

Nagham R. Sheblaq, BSc. Pharma, CCRP

Clinical Research Supervisor-Oncology Department

National Guard Health Affairs

Ms. Sally Qaryouti

Administration Office for

Chairman of Oncology Department Ministry of National Guard Health Affairs King Abdul Aziz Medical City, Riyadh

Welcome Message

-

Chairman

Dear Delegates and Collegues,

It is our pleasure to welcome the participants in the 3rd Clinical Research Training Course 2014,

07-08 February, Jeddah, Saudi Arabia.

In this workshop, participants will learn the proper design of research study with direct tutoring

and hands on experience.

At the end of the course, participants should have a draft of research proposal that we hope it

will be translated into a real life project.

Many thanks to our speakers, moderators and instructors for their efforts and time spent to make

this event worthwhile.

We hope that you enjoy and learn from this experience and have a fruitful meeting.

Best of Luck

Prof. Abdul Rahman Jazieh, MD, MPH

Chairman, CRTC2014

Chairman, Saudi Lung Cancer Association Chairman, Oncology Department

Professor, King Saud bin Abdulaziz University for Health Sciences Ministry of National Guard- Health Affairs

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Objective:

• To educate participants about the principles of good clinical trial design and provide them

with the necessary tools required to conduct trials that are relevant to the region.

• Each participant will develop a draft protocol for their own clinical research project.

Target Audience:

• Physician from all specialties.

• All health care professionals with interest in clinical research.

Workshop Instructors:

• Senior Investigators.

• Clinical Research Logistic Experts.

• Biostatisticians.

Workshop Theme:

• The workshop will last for two days.

• Participants will be divided to three groups; each group will have three experts to help them

in writing their assignment during the breakout session.

• One on one statistical consultation will be available.

Requirements:

• Each participant has to fill a proposal template prior to the workshop.

• Participants should bring their own laptop.

Faculty:

Day 1: February 07, 2014

Time

Topic

Presenter

07:30 - 08:00 Registration

Session 1: 08:00 - 09:30

Moderators: Dr. Samia Al Amoudi, Riyadh, Saudi Arabia - Dr. Wasil Jastaniah, Jeddah, Saudi Arabia Dr. Huda Abdulkareem, Riyadh, Saudi Arabia

08:00 - 08:30 Overview / Phases of Clinical Research Dr. Hani Tamim, Beirut, Lebanon 08:30 - 09:00 Searching the Literature/ Reference Formatting Dr. Ali Hajeer, Riyadh, Saudi Arabia 09:00 - 09:30 How to define your research question?-Clinical Research _Objective Dr. Rabab Gaafar, Cairo, Egypt 09:30 - 10:00 Break

10:00 - 12:00 Breakout Session 1_Assignment:_{Write Background/ Study Rational / Study Objective Sections} 12:00 - 13:00 Prayer • Lunch Break

Session 2: 13:00 - 14:30

Moderators: Dr. Rabab Gaafar, Cairo, Egypt - Dr. Medhat Faris, Dammam, Saudi Arabia

13.00 - 13:45 Study Procedure Requirements _{(Study Setting/ Eligibility Criteria/ Work Plan)} Dr. Fazal Hussain, Riyadh, Saudi Arabia 13:45 - 1430 Statistical Design of Clinical Research/ Sample Size _Calculation Dr. Abdul Salam, Al Hasa, Saudi Arabia 14:30 - 15:00 Break

15:00 - 16:00 Breakout Session 2 - Assignment: Write Study Procedure/ Study Design/ Sample Size Sections 20:30 Dinner

Day 2: February 08, 2014

07:30 - 08:00 Registration

Session 3: 08:00 - 10:00

Moderators: Dr. Adnan Hebshi, Jeddah, Saudi Arabia - Dr. Adda Bounedjar, Algeria Dr. Ahmed Al Shehri, Jeddah, Saudi Arabia

08:00 - 08:45 Data Management & Documentation _{(Designing Case Report Form-CRF Documentation)} Dr. Fazal Hussain, Riyadh, Saudi Arabia 08:45 - 09:30 Ethical Consideration During Clinical Trial (Consent Form _Component) Ms. Nagham Sheblaq, _{Saudi Arabia} Riyadh, 09:30 - 10:00 Study Budget Dr. Munir Abuhelalah, Amman, Jordan 10:00 - 10:30 Break

10:30 - 12:00 Breakout Session 3 - Assignment: Develope CRF/ Consent Form/ Budget sections 12:00 - 13:00 Prayer • Lunch Break

Session 4: 13:45 - 15:15

Moderators: Dr. Peter Cahusac, Riyadh, Saudi Arabia - Dr. Hamed Hussaini, Riyadh, Saudi Arabia Dr. Sulaiman Al Ghamdi, Riyadh, Saudi Arabia

13:00 - 13:45 Good Clinical Practice (GCP) Overview Ms. Nagham Sheblaq, _{Saudi Arabia} Riyadh, 13:45 - 14:30 Research Team Members Roles and Responsibilities Dr. Abdul Rahman Jazieh, _{Saudi Arabia} Riyadh, 14:30 - 15:15 Clinical Research Lifecycle (Site Initiation/ Screening/ _{Recruitment/ Enrollment Monitoring/ Audit Visit)} Dr. Munir Abuhelalah, Amman, Jordan 15:15 - 16:00 Closing Remakrs and Certificate Distribution

Scientific

Program

General

Information

Fazal Hussain, MD, MPH

Research Unit, Oncology Centre King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia Prof. Ali Hajeer

Professor of Immunology Chairman, Department of Basic Medical Sciences

College of Medicine, KSAU-HS

Dr. Abdul Salam

Biostatistician

King Abdullah International Medical Research Center National Guard Health Affairs

Nagham R. Sheblaq, BSc. Pharma, CCRP

Clinical Research Supervisor-Oncology Department National Guard Health Affairs

Hani Tamim, PhD

Associate Professor, Department of Internal Medicine

Director, Biostatistics Unit, Clinical Research Institute

Director, Fellowship and Residency Research Program American University of Beirut Medical Center

Beirut, Lebanon Prof. Abdul Rahman

Jazieh, MD, MPH

Chairman of the Course & Scientific Committee Chairman of Oncology Department

Ministry of National Guard King Abdul Aziz Medical City

Dr. Munir Abuhelalah

Regional Director, Middle East and North Africa Global Center for Public Health and Disease Control, Ohio, USA

Assistant Professor of Epidemiology and Preventive Medicine, Mutah University

Karak, Jordan

Rabab Mohamed Gaafar

Professor Medical Oncology National Cancer Institute, Cairo University

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Group Team

Leaders

Our Main

Sponsors

Expertise*

Group A

Group B

Group C

Biostatistician

Dr. Hani Tamim Dr. Ahmed Gasemelseed Dr. Abdul Salam

Logistic Expert

Ms. Nagham Sheblaq Dr. Munir Abuhelalah Dr. Fazal Hussain

Clinical Expert

Dr. Rabab Gaafar Dr. Abdul Rahman Jazieh Dr. Sami Khatib

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Sponsor

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