Health regulation in the UAE is split by emirate, and trial oversight has been moving to a federal body. Capture is a self-serve EDC with EU and US hosting that teams can test free before they settle the local data questions.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
United Arab Emirates
Key points for studies in the UAE
Regulation
For a multicentre study the practical map is: the EDE for the product and trial authorisation, the ethics committee of the emirate where each site sits, and the health authority that licenses the facility. Sponsors with sites in more than one emirate should plan for more than one ethics decision. The sources are law-firm and industry guides, not regulator texts, so treat each point as a lead to confirm.
What any of these bodies will want from a data system is a clear description of what is collected and how it is protected. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which suits the protocol and ethics package. Every field change carries a timestamp, the user, the old and new value and the reason, and the trail cannot be edited through the interface. See audit trail software for clinical trials.
Before you choose an EDC, ask the relevant authority whether trial data from your sites may be stored or processed outside the UAE, and in which cases. The answer may differ by emirate and by data type (identifiable health data, genomic data, coded data). If in-country storage is required, a platform without a UAE region will not meet it. Capture does not offer one.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Who does what
| Step | Who | What is needed | Where Capture helps |
|---|---|---|---|
| Trial and product authorisation | Emirates Drug Establishment | Protocol, product information, import permit | Blank eCRF PDF of the approved forms. |
| Ethics approval | Committee of the emirate (for example DSREC in Dubai) | Protocol, consent, investigator details | eConsent record with countersignature and signed PDF. |
| Facility and site start-up | DHA, DoH or MOHAP-licensed facility, principal investigator | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Data handling | Sponsor, CRO, data protection counsel | Hosting, transfer and retention decisions | EU or US hosting, role-based access, PII segregation. |
| Ongoing oversight | Sponsor monitors, authorities | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources and may be out of date. Confirm each step with the relevant authority.
Set up visits, forms and checks free, share the blank eCRF PDF with your ethics committee, and pay only when real participants enrol.
Data protection
A federal personal data protection decree-law, health-sector data rules and emirate-level standards (DoH Abu Dhabi has a healthcare data privacy standard, per sources) may all apply to a trial, and how they interact is a question for counsel. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For sponsors who also fall under the GDPR the Frankfurt region may suit; see GDPR compliant clinical trial software and HIPAA vs GDPR for clinical trial data.
In Capture, site coordinators see participant names while researchers see coded IDs, and row-level security enforces that at the database. Data is encrypted with AES-256 at rest and TLS in transit. Whether a coded-data study with identifiers held only at the site meets a local data rule is a question for the authority, not this page.
Consent
Capture eConsent takes the participant on-screen signature, confirmed by a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported, and each signature is hashed to the exact document content. The signed PDF carries timestamps and the audit trail. Language support is not claimed here, so confirm what is available before planning Arabic or English-and-Arabic screens.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Wider context
Studies in the UAE are often part of a Gulf or Middle East programme. Neighbouring guides: Saudi Arabia, Turkey and Egypt. For another market where committee review precedes the regulator, see Mexico. For running sites across borders, read multi-site clinical trial management.
Sources describe the Emirates Drug Establishment as overseer of trials of medical products, with MOHAP, DHA and DoH Abu Dhabi as health authorities and ethics committees at emirate level. The framework has been changing, so confirm with the authorities.
Sources describe ethics review at emirate level. A study with sites in several emirates should expect more than one decision. Confirm with each committee.
This depends on the data type and the emirate. One source reports restrictions on genomic data in Abu Dhabi. Ask the relevant authority and counsel. Capture hosts in the EU and the USA only.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). Capture has no UAE data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what an inspector looks at.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Arabic screens.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Saudi Arabia
Gulf neighbour.
Clinical trial software in Turkey
Regional market.
Clinical trial software in Egypt
North Africa and Middle East.
Clinical trial software in Mexico
Committees before the regulator.
HIPAA vs GDPR for trial data
Which regime applies to you.
GDPR compliant clinical trial software
Processor and hosting questions.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.