Saudi trials run through the SFDA, an IRB registered with the national bioethics committee and a young data protection law with a stated preference for data staying in the Kingdom. Capture hosts in the EU and the US, so the transfer question comes first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Saudi Arabia
Key points for studies in Saudi Arabia
Regulation
The SFDA regulates clinical trials of medicinal products in Saudi Arabia and publishes guidance on conducting drug clinical trials. The application is made electronically, and the Saudi Clinical Trials Registry holds the official record of drug studies in the country. Industry sources advise setting up registry accounts before you begin preparing the application.
One secondary source states that sponsors without a legal entity in Saudi Arabia must apply through an SFDA-licensed Saudi CRO. If that applies to you, the CRO is the submission and oversight partner, and the EDC choice is yours or the CRO choice. Capture works as a self-serve platform the sponsor or CRO configures, with no local partner of its own. Confirm the requirement directly with the SFDA, since guidance changes.
Inspections and monitoring will look at records. Expect questions on who entered what, when and why. Capture records every change with timestamp, user, old value, new value and reason for change in an append-only audit trail, and edit checks raise queries automatically. For what to show an inspector see audit trail software for clinical trials and risk-based monitoring and SDV software.
University hospitals, ministry hospitals and private hospitals typically have their own IRBs, registered with the NCBE under the research ethics law and its implementing regulations. A multi-site study usually needs approval from each institution or a recognised arrangement between them. Ask each site research office which IRB applies, and whether the NCBE needs notification if samples will be sent abroad. See how to get IRB approval for a package list.
Data protection
Saudi Arabia enacted the Personal Data Protection Law by royal decree, with implementing regulations and a separate regulation on transfers outside the Kingdom, supervised by the Saudi Data and AI Authority (SDAIA). Commentary on the healthcare sector notes that health data is sensitive personal data, and that the legitimate interests basis does not apply to it. That raises the bar on consent and purpose for research.
On transfers, the draft executive regulations that we found described a starting position that personal data should be stored and processed in the Kingdom, with transfers abroad allowed when conditions are met or when the controller applies for approval, and a notice period of at least 30 days for an application. Another source says a university collaboration form requires standard contractual clauses for transfers. These are secondary and partly draft sources, so check the final text and any health-sector rules before relying on them.
For Capture the position is plain. Data is hosted in Frankfurt or N. Virginia. If a Saudi institution or the SFDA requires trial data to remain in the Kingdom, or if counsel concludes that the transfer conditions cannot be met, Capture should not be used for that data. If the transfer is permitted, document the basis in consent and in the agreements, use coded IDs for sponsor-side users (site coordinators see names, researchers see coded IDs), and rely on encryption (AES-256 at rest, TLS in transit).
Sites
4
Hosting
EU or US
Items open
3
Build the forms and export the blank eCRF PDF for the SFDA and IRB package in the free sandbox.
Planning
| Task | Who usually owns it | Note for the data system |
|---|---|---|
| SFDA application and registry | Sponsor, or the Saudi CRO if the sponsor has no local entity | The blank eCRF PDF shows what will be collected. |
| IRB submission and NCBE matters | Principal investigator with the site research office | Consent PDF with signatures and audit trail. |
| Import of investigational product | Sponsor or CRO with the importer | Kit and shipment records stay with supply logistics. |
| Data protection assessment | Sponsor with Saudi counsel and the site | Document hosting, access roles and transfer basis. |
| Safety reporting | Investigator and sponsor safety team | SAE alerts and timelines set in the safety plan. |
| Monitoring | CRA or sponsor monitor | Field-level SDV flags, queries and audit trail. |
Roles differ by study. Confirm with the SFDA and your Saudi CRO.
Consent
Capture eConsent records the participant signature on screen, verified with a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported. Each signature is hashed to the document content and the signed consent exports as a PDF with timestamps and audit trail. The consent wording, and whether electronic consent is acceptable at a given site, are for your IRB to decide. Prepare any Arabic versions with your own translators.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Saudi research
Saudi Arabia is investing heavily in its life sciences and healthcare sector, with major hospitals in Riyadh, Jeddah and the Eastern Province running industry and investigator-initiated studies, and a national registry that makes trials visible. Sponsors enter through a Saudi CRO or a local entity, often as part of a Gulf or Middle East programme.
A self-serve platform suits investigator-initiated and academic studies where a team wants to design its own eCRFs. See EDC for academic clinical trials and clinical trial software without a CRO. For large global sponsors, a Saudi site is one site among many: see multi-site clinical trial management and Turkey for another regional regime.
Before you start
Application pathway confirmed and accounts created in the Saudi Clinical Trials Registry.
Local representation confirmed if the sponsor has no Saudi legal entity.
NCBE-registered IRB at each site, with notification steps for samples leaving the Kingdom.
Final transfer regulations reviewed and a lawful basis documented, or a decision that data must stay in the Kingdom.
Consent and participant materials translated and approved by your team and the IRB.
Paper source and delayed entry planned for sites without reliable access, since Capture has no offline mode.
The SFDA approves drug trials, and an IRB registered under the research ethics law reviews each study. The Saudi Clinical Trials Registry holds the official record. Confirm current requirements with the SFDA.
A secondary source says sponsors without a legal entity in Saudi Arabia must apply through an SFDA-licensed Saudi CRO. Check this with the SFDA. Capture is not a CRO.
Draft executive regulations described a default of storing and processing in the Kingdom, with transfers allowed under conditions or with approval. Check the final regulations and the health-sector rules with Saudi counsel.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia) only. If your study must keep data in the Kingdom, Capture is not the right fit for that data.
This page makes no claim about Arabic or other language support. Ask in a demo what is available, and prepare approved Arabic materials with your own translators.
No. Capture is web based and needs a connection. Plan paper source and delayed entry for sites that cannot rely on a connection.
No regulator registers or approves EDC software of this kind. Capture provides an audit trail, e-signatures and access controls. Your validated use is what is assessed.
Yes. The free sandbox has every feature, with no credit card and no time limit.
Keep exploring
Clinical trial software in Turkey
TITCK and the KVKK.
Clinical trial software in India
CDSCO, CTRI and the DPDP Act.
GDPR compliant clinical trial software
Transfer principles for EU hosting.
Risk-based monitoring and SDV
Monitoring evidence.
How to get IRB approval
What committees ask for.
eConsent software
Verified electronic signatures.
Build and test your Saudi study free, and take the hosting question to counsel. Pay only at go-live.