Clinical Research Department

 

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:

 

Provided by the Sponsored Companies:

  • Study Protocol (not a synopsis)
  • Case report form (electronic CRF completion guide)
  • Investigator Brochures
  • 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)

 

 

Contact Information:

Email: Clinical-research@kfshrc.edu.sa

Email: clinicaltrialsunit@kfshrc.edu.sa

Phone:  +966114647272 Ext: 73324