General Information:

Venue: Research Centre Building, 3^rd Floor, Room 304.

Entry requirements:

To be accepted into the course, candidates must:

-          Hold at least an Associate’s Degree in the health care related fields.

-          Has a working experience in clinical care or clinical research.

-          Be fluent in spoken and written English.

Who should attend: 

• Persons currently working, or interested in working, in the various fields of clinical research including: physicians, nurses, pharmacists, clinical coordinators, research ethics committee members, and research administrators.

Educational Objectives:

• Upon successful completion of the course, participants shall have an in depth understanding of globally accepted scientific, statistical, ethical, and regulatory guidelines for the conduct of clinical research as well as various clinical trial procedures from pre-study activities to study completion. Participants should be able to write a simple clinical research proposal, critically appraise a clinical research paper, carry out the diverse clinical research functions, apply ethical decision-making, effectively serve on research ethics committees, and perform compliance measures for clinical trials.

Content:

The course is intensive and condensed, given in English, and comprises of two parts.

Part I: Pre-course (4 weeks)

A very important preparatory part that consists of four, weekly reading and homework assignments sent via e-mail. Participants are expected to complete/submit assignments in a timely manner.

Part II: Course (2 weeks)

This part is held in room 304, Research Centre, KFSH&RC, Riyadh, Saturday to Wednesday from 8:30 am to 5 pm. It consists of lectures, workshops, student group presentations, and multiple choice questions (MCQ) review sessions. The following topics are covered:

•  Historical events and important documents in medical research.
•  Remuneration in research.
• Philosophical approaches to ethics (relativism, pluralism, who counts, rights/respect, utilitarianism, egoism, ethics of care, justice, virtue, common good) and their applications in clinical Research.
• Research fraud and misconduct.
• Conflict of interests.
•  Pre-study, study initiation, and clinical study activities.
• Clinical study methods.
• Clinical study designs.
• Sample size determination.
• Statistical concepts in clinical research (hypothesis testing, common statistical tests, clinical importance & statistical significance, confidence intervals, correlation & causation, interaction, measurement scales, errors & bias, relative risk, odds ration and survival analysis).
•  Case report forms.
• Drug development process/bioequivalence studies.
• Local and international clinical research regulatory organizations.
• Clinical research professionals organizations.
• Diagnostic tests study (sensitivity, specificity, predictive values, etc).
• The informed consent process.
• The research ethics committees.
• Amendment and reports.
• Privacy and confidentiality.
• Intellectual property.
• Writing a clinical Research proposal.
• Data safety and monitoring committees.
• Registering clinical trials.

Performance Grading

Performance grading is based on timely completion of the precourse assignments, group presentations, and a two parts written examination. ³ 88% attendance is required to sit for the exam. 

Accreditation & Certificates

• Accredited by SCHS and AACME
• Certificate of Attendance:  All participants will receive a certificate of attendance indicating the accrued SCHS CME hours. A separate AACME attendance certificate will be sent via Academic Affairs, KFSH&RC, few weeks after completing the course.  Students passing the course’s exam will received a certificate for successful completion of the course.

Registration/Visa & Forms

• Fee:  Two Thousand Five Hundred Saudi Riyals (SR 2,500). The fee does not cover accommodations or transportation.
•  How to apply: 
• Complete the attached application form (or a copy thereof).
• Include a CV summary or a brief letter describing experience in clinical research, if any.
• Deposit the course fee of SR 2,500 in the CCSEE at Al-Rajhi Bank, account number 1146080100740049. Proof of deposit must be forwarded to the CCSEE along with the application form.
• Fax or email the application form, proof of deposit, and CV summary/letter to the CCSEE.
• Requirement must be received by the CCSEE no later than 16 September 2009 (26 Ramadan 1430).

For applicants from outside the Kingdom of Saudi Arabia, please complete the VISA BIO-DATA Information Sheet. Visas will not be process until full payment of the registration fee and completed forms are received.

•             To expedite visa processing, please send a COPY OF PASSPORT PHOTO PAGE showing your full name, passport#, nationality, date of birth, place of issue and validity.
•            Please send required information by email, fax or airmail to address shown below.  This information must be received in our office not later than 15^th August 2009 for processing.  Please note that the Ministry of Interior requires a religion be indicated.  “None” is not acceptable.

The number of seats is limited. Interested candidates are encourage to apply as early as possible.

Please contact the CCSEE to confirm the availability of seats before deposition of fee.

Accommodation

Not provided.

Contact Us:

Marivic G. Ventura

Centre for Clinical Studies and Empirical Ethics

Research Centre Building, 2^nd Floor, Room 203

Tel. No.:  +966-1-4424582

Fax No.:  +966-1-4424971

Email: mventura@kfshrc.edu.sa /ccr@kfshrc.edu.sa