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Course Description
This course teaches the globally accepted guidelines and practices necessary to conduct research that is of the highest attainable ethical, scientific, and safety standards. The information presented will prepare the
students to perform a variety of clinical research activities while protecting human research subjects and advancing valid clinical research. Through lectures, discussions, independent studies, workshops, and hands-
on practical experience, students will gain the required knowledge and skills to participate effectively and efficiently in planning, conducting, coordinating, monitoring, and auditing clinical trials.
This course comprise of a didactic (Part I) and a hands-on (Part II) component:
Part I: Two weeks (approximately 80 hours) of classroom and application instructions / workshops. This component is held Saturday to Wednesday from 9 am to 5 pm for two consecutive weeks.
Optional
Part II: An elective internship of up to four –weeks. This will be offered to students who successfully complete Part I one of the course. The internship will be scheduled and designed to
accommodate the time schedules, objectives, needs, and prior clinical research related experiences of individual students.
Course Objectives:
At the conclusion of this course, students shall have/be able to:
- An in-depth understanding of globally accepted scientific, ethical, and regulatory guidelines and practices for the conduct of clinical research.
- An in-depth understanding of the various clinical trial procedures from pre-study activities to study completion.
- Adequate practical skills and hands-on experience to carry out the various functions necessary to coordinate a clinical research study.
- List the major steps in the drug development process.
- Apply ethical decision making.
- Perform compliance measures for clinical trials
Who Should Attend this Course?
Persons currently working, or interested in working, in the various fields of clinical research including: investigators, coordinators, nurses, pharmacists, data managers, research ethics committee members, and
hospital /research administrators,
Course entry requirements
- To be accepted into the course, candidates must hold at least an Associate's Degree or a Bachelor's Degree in science, nursing, medicine, health sciences, pharmacy, or related fields ORhave two years full-time
experience, or 3500 hours part-time experience during the last five years, in clinical research in any capacity.
- Candidates must be fluent in spoken and written English.
Venue
Research Center Third Floor, Classroom #304
Time
0900-1700 daily from Saturday to Wednesday for two weeks.
SCHS Accreditation
This course is accredited by the Saudi Council For Health Specialties (SCHS). The numbers of CMEs are 30 Hours, Council Eligibility Number (3646/3/2003),
and Date (10/11/1423).
AACME Credit Designation Statement
The American Academy of Continuing Medical Education (AACME) is the sponsor of the continuing medical education portion for this symposium.
AACME designates this continuing medical education activity for a maximum of "42.50" hours in Category 1 credit of the Physician's Recognition Award.
Each physician must claim only those hours of credit that he/she actually spent in the educational activity.
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If you need further information, please contact:
Eman Al Gaai, RPh, CCRP, or
Marilyn Lockyer, RN, CCRP
Centre for Clinical Research
MBC 03, Research Centre
King Faisal Specialist Hospital and Research Center
B. O. Box 3354 Riyadh 11211
Saudi Arabia
Telephone 966-1-442-4986
Email: ccr@kfshrc.edu.sa
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