Organization : Saudi Food & Drug Authority
Type of Facility : Saudi Clinical Trials Registry
Country: Saudi Arabia
Website : https://sctr.sfda.gov.sa/Home.aspx
Saudi Clinical Trials Registry :
The Saudi Clinical Trials Registry (SCTR) is the entity that houses a formal record for all CTs data in Saudi Arabia.
It is responsible for ensuring the completeness and accuracy of the information contained in the register, and that the formal record of an internationally agreed minimum amount of information about a clinical trial is published on a publicly-accessible website.
Security and Confidentiality of Data:
All data submitted online will be protected and encrypted via the SCTR security infrastructure.
Guidance for SCTR Phase IV :
1. Visit SCTR webpage. sctr.sfda.gov.sa/
2. Log in SCTR using your Username & Password.
3. If you don’t have a username please Create a new account.
4. if forget your password use (forgot your password ) button
FAQs:
Q . What is the SCTR?:
A. The Saudi Clinical Trials Registry (SCTR) is the entity that houses a formal record for all CTs data in Saudi Arabia. It is responsible for ensuring the completeness and accuracy of the information contained in the register, and that the formal record of an internationally agreed minimum amount of information about a clinical trial is published on a publicly-accessible website.
Q . Who should use the SCTR?:
A. All the companies that are interested in conducting any clinical trial in Saudi Arabia.
Q. When I can login or access the SCTR?:
A. You can login or access anytime during the day & night.
Q. What are the required information & documents for Clinical Trial registration?:
A. Please, refer to the “Clinical Trail Memo” for more information.
Q. How to submit an application?:
A. To submit an application, you will have to do the following:
** Choose the appropriate application.
** Complete all the required information.
** Then, you can submit the application.
** Afterwards, choose the available appointment to hand the drug file over to the drug registration building
Note that you can save the application at any section and complete it later. Also, you can edit any information in the application before submitting It.
Q. What happens after taking an appointment?:
A. On the appointment day you have to be on time and to bring with you all the required documents.
Q. Can I postpone my appointment that I have chosen?:
A. No you cannot modify it after you complete the registration process.
Q. What happens if I missed my appointment?:
A. you should notify Clinical Trial Department and login to SCTR and reschedule a new appointment.
Q. Who to contact if I need assistance?:
A. For help please send an email to ct.drug AT sfda.gov.sa Or call Clinical Trial Department on the following number: 0112038222 EXT. 5720 , 5391, 5792 , 5774 or 2342.