1.    Clinical Trials Evaluation division: 

  • Develop rules and regulations for the conditions and mechanism of implementation of clinical trials.
  •  Evaluation of clinical trial files to be conducted in Saudi Arabia.
  •  Update the Guidelines and Guidance for  clinical trials.
  •  Meet all the requirements, standards and regulations for conducting clinical trials in accordance with the World Health Organization to get the highest global standards in the implementation of clinical trials in the region.
  •  Evaluation of ADRs & SUSARs for clinical trials.
  •  Evaluation of “Compassionate use applications”.
  •  Participate in evaluation of importation and exportation applications regarding clinical trials.

  

2.    Saudi Clinical Trials Registry (SCTR) division: 

  • Create a database for all registered clinical trials in Saudi Arabia.
  • Registration of researchers in medicinal field in Saudi Arabia (individuals and companies).
  • Receiving clinical trial applications from companies and individual researchers, review applications and scheduling appointments to receive CT files for evaluation.
  •  Receiving amendments, termination and close up reports for clinical trials.
  •   To make the database for clinical trials registered in the Kingdom a reference to the public, patients and health care providers.
  •  Increase the awareness of researchers to the registration of clinical trials.
  •  Data analysis and preparation of reports and statistics to contribute in the implementation of the Drug sector and CT department missions.

 (For more information regarding Saudi Clinical Trials Registry please click HERE)

  

3.    Clinical Trials Centers, CROs and GCP inspectors division:

  •  Monitoring and follow-up of clinical trial centers and implement inspection visits on clinical trial sites to ensure that the researchers and research institutes are committed to all parts mentioned in the study protocol in addition to the fulfillment of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations.
  • Ensure the safety of participants / volunteers in any clinical trial conducted in the Kingdom.
  • Cooperation with the research institutes, medical research centers and pharmaceutical companies to strengthen research experience in the field of clinical studies.
  •  Ensure that all clinical trial sites in the Kingdom are registered at the Saudi Food and Drug Authority.
  •  Follow the work of contract research organizations (CROs) and Clinical Trials Monitoring Centers (CTMCs).
  •  Update regulations related to the good clinical practices.