Who we are:
The Clinical Research Department (CRD) at KFSH&RC was established in December 2020 under the patronage of KFSH&RC leadership to promote and facilitate prospective clinical trial activities at KFSH&RC and provide an access for our patients to be enrolled and treated on cutting edge international prospective clinical trials. The department will serve as a centralized bureau to coordinate and supervise the conduct of prospective clinical trials initiated by the institution’s investigators (investigator-initiated trials) or supported by the industry (sponsored-trials). As a centralized office, the department will be the starting point to conduct prospective clinical trials at KFSH&RC. The CRD offers the physical space and experienced multidisciplinary support staff to conduct and complete prospective clinical research at KFSH&RC.
We provide “one-stop-shop” assistance and coordination services for Phase II-IV (soon will include phase I) prospective clinical trials spreading over all sub-specialties of KFSH&RC. The CRD is responsible for reviewing, submitting and following all prospective clinical-trial proposals in compliance with standard guidelines. The CRD will follow and communicate with all the appropriate stakeholders to expedite the submission/approval process. Clinical Research Department at KFSH&RC is committed to protecting the rights, dignity, welfare, and privacy of human subjects.
All clinical research overseen and conducted at KFSH&RC irrespective of funding must be reviewed by the hospital IRB and then to go through local regulators.
Vision:
To be recognized as a leading global research institute running cutting edge hi-tech and advanced therapeutics trials offering world class clinical solutions and to offer access for the patients to a novel, affordable, safe and effective healthcare solutions and innovative treatments to improve the health and wellness of people everywhere.
Mission:
- Provide an opportunity for our patients to safely participate in cutting edge national and international research
- Promote and facilitate prospective clinical trial activities at KFSH&RC and KSA
- To promote novel gene therapy that offer hope for people with certain diseases
- To enhance the quality of clinical trials in Saudi Arabia
Our Services:
- Offer advice and directions (for PIs and sponsors) on the conduct of prospective clinical trials at KFSH&RC
- Assess and discuss the feasibility of prospective clinical trials at KFSH&RC
- Plan and set up prospective clinical trials
- Protocol development
- Execute all the communications between the sponsor, the PI and IRB to expedite the process
- For investigator-initiated prospective clinical trials the Clinical Research Department will be in charge of SFDA submission and follow up on the behalf of the PI
- Subject recruitment
- Project coordination
- Data management
- Investigational drug management
- Site monitoring
- Safety reporting
- Quality assurance
- File progress reports
- Final report submission
- Data archiving according to study requirements
Clinical Trial Package preparation and requirements
KFSH&RC Forms:
Other requirement:
- Study Protocol (not a synopsis)
- Case report form (electronic CRF completion guide)
- Subjects “Questionnaires” or “Thank You” cards or Patient Materials
- Subject Insurance certificate
- National Committee of Bio Ethics (NCBE) Form
- Financial Disclosure Forms (FDFs)
- Letter List of documents
- If there is any Subject Information form (Bilingual EN & AR)
- Investigator Brochures
Donation and volunteering:
- Volunteers are an integral part of the research process. Many different types of people take part in clinical research. Some are healthy, while others may have illnesses. People volunteer for clinical studies help doctors and researchers learn more about disease and improve health care for people in the future.
- For more information regarding the protection of human subjects participating in research and to volunteer in clinical trials at KFSH&RC, please contact us by: Phone: +966114647272 Ext: 73324. Or email us at: clinicaltrialsunit@kfshrc.edu.sa.
Contact Information:
Email: Clinical-research@kfshrc.edu.sa.
Email: clinicaltrialsunit@kfshrc.edu.sa.
Phone: +966114647272 Ext: 73324.