Turkish trials need two favourable decisions, one from an accredited ethics committee and one from TITCK, and the KVKK rewrote its cross-border transfer rules in 2024. Capture gives Turkish teams a self-serve EDC to build and test free, hosted in the EU or US.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Turkey
Key points for studies in Turkey
Regulation
In Turkey the ethics committee and TITCK review in parallel, and both must conclude favourably before a trial starts. The committee looks at the protocol, consent documents, investigator suitability and participant protections. TITCK looks at the investigational product dossier, GCP compliance and safety. Applications are submitted through EBS, and the clinical trial regulation for medicinal products sets the documents required.
Plan the package early. Capture gives you a blank eCRF PDF with a cover page, form index and visit-by-form matrix, and every approved form printed empty. That helps both the committee and TITCK see exactly what data the trial collects. For Turkish-language consent and participant information, your team prepares and has approved the text. Capture stores whatever approved wording you enter and records which version each participant signed. This page makes no claim about built-in Turkish language support, so ask in a demo what is available.
Safety reporting is a recurring theme. Turkey has its own reporting arrangements for suspected unexpected serious adverse reactions, including a national module that one guide dates to May 2026, which we could not verify. Set out safety timelines in your plan and check them with TITCK. In Capture a serious event raises a routed safety alert and the SAE form carries the fields your safety team needs. See SAE reporting timelines guide and adverse event reporting software.
Where the sponsor has no representative resident in Turkey, applications are reported to go through a contracted research institution in Turkey, which then acts as a point of contact with TITCK. Choose that partner before you build the study, because their template expectations, monitoring approach and data access needs affect forms and roles.
weeks
Free sandbox
Data protection
Health data is special category data under KVKK, so processing needs a specific legal basis and technical and organisational safeguards. Commentary notes that data collected under a trial protocol can be reused in later research if it complies with the law, and that use beyond the protocol needs consent that the participant can withdraw at any time.
Law No. 7499, published in the Official Gazette in March 2024, replaced the earlier transfer regime in Article 9. Sources describe three tiers: transfer on the basis of an adequacy decision by the Personal Data Protection Board; transfer with appropriate safeguards, such as a standard contract published by the Board, binding corporate rules or a written undertaking, some of which need the Board permission; and limited exceptional cases. The standard contract has to be notified to the Authority within five business days of signing, and failing to notify can itself draw an administrative penalty. Sources differ on the effective date, so confirm it and the current standard contract text.
For a sponsor using Capture, the question is which of those mechanisms covers transfer from Turkish sites to an EU or US hosted system, and who signs it. Ask Turkish counsel, document the answer in the clinical trial agreement and in participant information, and keep identities at the site: coordinators see participant names, researchers see coded IDs, enforced by row-level security, with AES-256 at rest and TLS in transit. See GDPR compliant clinical trial software and HIPAA vs GDPR clinical trial data.
Create forms, edit checks and a blank eCRF PDF for the committee package in the free sandbox.
Reported durations
These are reported, not guaranteed. Use them only to size your plan and check with TITCK.
| Step | One law-firm alert | Other guides | What to do |
|---|---|---|---|
| Ethics committee review | About 12 business days if complete | 2 to 4 weeks | Submit a complete package and track questions. |
| TITCK review | About 22 business days if complete | 4 to 6 weeks | Respond to deficiency letters quickly. |
| Application route | EBS electronic system | EBS electronic system | Create accounts early; sponsor or institution files. |
| Sponsor without Turkish representative | Contracted research institution files | Same | Choose the institution before study build. |
| KVKK standard contract | Notify the Authority within 5 business days of signing | Same | Add to the contracting checklist. |
Data quality
When a site enters a value that breaks a rule, Capture raises an auto-query straight away. Calculated fields such as BMI and eGFR appear read-only during entry, and source data verification can be set per field. That keeps Turkish site data clean in real time and gives monitors a short list of queries to review.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Turkish research
Turkey has large university hospitals and city hospitals in Istanbul, Ankara and Izmir, a sizeable generic and biotech sector, and a patient pool that makes it a common part of European, Middle Eastern and global trials. Investigator-initiated studies from universities run alongside industry trials.
For multi-country studies, one study configuration across sites helps: multi-site clinical trial management and clinical trial randomization software cover site-level numbering, stratification and shared definitions. For neighbours with different regimes see Saudi Arabia and Germany.
Before you start
Sponsor or contracted institution registered, with the package prepared.
Accredited committee identified and submission made in parallel with TITCK.
Consent, participant information and questionnaire text translated and approved by your team.
Transfer mechanism chosen with counsel, and any standard contract notified within five business days.
Timelines and recipients set for SUSARs and SAEs, checked with TITCK.
Local partner chosen if the sponsor has no Turkish representative.
TITCK, the Turkish Medicines and Medical Devices Agency, reviews the product dossier, and an accredited clinical research ethics committee reviews the protocol and participant protections. Both must be favourable. Confirm current requirements with TITCK.
The electronic application system through which clinical trial applications are submitted. Check access and accounts with TITCK or your contracted institution.
Law No. 7499 rewrote Article 9 on transfers abroad into an adequacy, appropriate safeguards or exceptions structure, with a standard contract that must be notified to the Authority within five business days of signing. Sources differ on the effective date, so ask Turkish counsel.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Document the transfer basis in your contracts and participant information.
This page makes no claim about Turkish language support. Prepare approved Turkish materials with your own translators and ask in a demo what is available.
No. Capture is self-serve. If the sponsor needs a representative or contracted institution in Turkey, appoint one separately.
No regulator 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 Saudi Arabia
SFDA and the PDPL.
Clinical trial software in Germany
An EU hosting neighbour.
SAE reporting timelines guide
Plan safety clocks.
Query management software
Auto-queries and resolution.
Randomization software
Stratified by site or country.
GDPR compliant clinical trial software
Transfer principles for EU hosting.
Build and test your Turkish study free. Pay only at go-live.