The 3 rd Clinical Research Training Course



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The 3 rd Clinical Research Training Course Organized By: 07-08 February 2014 Radisson Blu, Jeddah, In Collaboration With: Event Venue: Main : 11 CMEs Hour Diamond Sponsor Silver Bronze Support Registration Fee: Registration: SAR3,750 Symposium Secretariat: Telephone: (+966) 11 462 2515 Mobile: (+966) 53 390 0411 E Mail: slca.lca.sts@gmail.com For Registration Please Visit:

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,. 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 Executive Committee 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, FAARC Executive Director, CRTC2014 Senior Clinical Respiratory Specialist King Faisal Specialist Hospital and Research Centre Nagham R. Sheblaq, BSc. Pharma, CCRP Clinical Research Supervisor-Oncology Department Ms. Sally Qaryouti Administration Office for Chairman of Oncology Department Ministry of King Abdul Aziz Medical City, Riyadh Ms. Hanan El Desouky Administration Office for Chairman of Oncology Department Ministry of King Abdul Aziz Medical City, Riyadh 1

General Information 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: 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 Prof. Ali Hajeer Professor of Immunology Chairman, Department of Basic Medical Sciences College of Medicine, KSAU-HS Nagham R. Sheblaq, BSc. Pharma, CCRP Clinical Research Supervisor- Oncology Department 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 Fazal Hussain, MD, MPH Research Unit, Oncology Centre King Faisal Specialist Hospital & Research Center 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 Rabab Mohamed Gaafar Professor Medical Oncology National Cancer Institute, Cairo University Cairo, Egypt Dr. Abdul Salam Biostatistician King Abdullah International Medical Research Center Scientific Program Day 1: February 07, 2014 Time Topic Presenter 07:30-08:00 Registration Session 1: 08:00-09:30 Moderators: Dr. Samia Al Amoudi, - Dr. Wasil Jastaniah, Jeddah, Dr. Huda Abdulkareem, 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, 09:00-09:30 How to define your research question?-clinical Research Objective 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, 13.00-13:45 Study Procedure Requirements (Study Setting/ Eligibility Criteria/ Work Plan) 13:45-1430 Statistical Design of Clinical Research/ Sample Size Calculation 14:30-15:00 Break Dr. Rabab Gaafar, Cairo, Egypt Dr. Fazal Hussain, Dr. Abdul Salam, Al Hasa, 15:00-16:00 Breakout Session 2 - Assignment: Write Study Procedure/ Study Design/ Sample Size Sections 20:30 Dinner 07:30-08:00 Registration Day 2: February 08, 2014 Session 3: 08:00-10:00 Moderators: Dr. Adnan Hebshi, Jeddah, - Dr. Adda Bounedjar, Algeria Dr. Ahmed Al Shehri, Jeddah, 08:00-08:45 08:45-09:30 Data Management & Documentation (Designing Case Report Form-CRF Documentation) Ethical Consideration During Clinical Trial (Consent Form Component) Dr. Fazal Hussain, Ms. Nagham Sheblaq, 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, - Dr. Hamed Hussaini, Dr. Sulaiman Al Ghamdi, 13:00-13:45 Good Clinical Practice (GCP) Overview Ms. Nagham Sheblaq, Riyadh, 13:45-14:30 Research Team Members Roles and Responsibilities Dr. Abdul Rahman Jazieh, 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 2 3

Group Team Leaders 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 * Dr. Ali Hajeer will provide guidance for basic science proposal Our Main Diamond Sponsor Silver Bronze Support 4 5

The 3 rd Clinical Research Training Course 07-08 February 2014 Radisson Blu, Jeddah, CONTACT P. O. Box 106911 Riyadh 11676 Tel. #: +966 11 4679066 or +966 11 2488966 Fax #: +966 11 4679496 or +966 11 2487431 Email: slca.lca.sts@gmail.com Saudi Lung Cancer Association (SLCA)/ Saudi Thoracic Society 2014, All Rights Reserved