KAP
Clinical Trials Portal
The public database holding records of clinical trials within TİTCK's mandate. The primary source for searching authorised trials and following the Turkish research landscape.
Official source
TİTCK · KAP · KAM — the English-Language Guide
The Türkiye Clinical Trial Regulatory Hub: TİTCK & KAP
TİTCK's clinical trial ecosystem — the KAP database, the KAM submission module, the National SUSAR system and the ethics pathway — is published mostly in Turkish. This hub explains the framework in English, step by step, for international sponsors: the application pathway, documents, timelines and the 2026 agenda.
Why Türkiye
A fast, inspectable regulatory framework at the crossroads of Eurasia
Türkiye offers international sponsors an ICH/GCP-aligned authority, a parallel-approval architecture and start timelines shorter than Western Europe's.
1.Parallel approvals, faster calendar
TİTCK and the ethics committee evaluate in parallel; a clean dossier is typically approved in 4–6 weeks in practice.
2.A lighter dossier burden
Türkiye requires neither an IMPD nor an EU-style QP release; scientific documents such as the protocol and investigator's brochure can be submitted in English.
3.A broad patient pool
A large, heterogeneous patient population, a strong investigator network and rapid enrollment in multi-center trials.
4.An inspectable framework
ICH/GCP-aligned legislation, risk-based GCP inspections and Trust Practices that accept foreign competent-authority inspection reports.
The TİTCK Digital Ecosystem
Four official components — explained in English here
Türkiye's clinical trial infrastructure is consolidated in one digital ecosystem: from registry to submission, safety reporting to legislation.
KAM · EBS
Clinical Trials Module · Electronic Application System
The submission module where clinical trial applications are standardised and finalised with e-signature — used across the entire lifecycle of a trial.
Official sourceNational SUSAR Module
Structured safety reporting
The structured, electronic reporting system for suspected unexpected serious adverse reactions (SUSARs), aligned with international standards.
Official sourceLegislation & Guideline Library
Regulations, guides, forms
The Clinical Trials Regulation, the KAD-KLVZ-02 (applications) and KAD-KLVZ-03 (ethics committees) guides, application forms and GCP resources.
Official sourceThis hub is an independent English-language summary prepared by Omega CRO and is not official legal advice. The authoritative source is the Turkish Medicines and Medical Devices Agency (TİTCK) — use the official links above for current regulations, guides and forms. Timelines reflect ranges observed in practice and vary with each dossier.
The Application Pathway
Six steps from preparation to close-out
A TİTCK submission is not a moment but a disciplined lifecycle. Each step maps to a distinct competency in Omega's regulatory team.
1
Feasibility & dossier preparation
Site selection and feasibility; Turkish patient-facing documents (informed consent form, protocol summary), the trial budget per TİTCK's budget format, and the clinical trial insurance policy.
2
Project set-up on KAP/KAM
The sponsor representative opens the project; sponsor, CRO, principal investigator and sites are registered; protocol, brochure, consent form, GMP and analysis certificates, CVs and the budget are uploaded.
3
E-signed submission, parallel review
The submission is finalised with e-signature. TİTCK runs the scientific-regulatory review while the assigned Clinical Research Ethics Committee runs the ethics review in parallel.
4
Deficiency letters & clock-stop
TİTCK raises administrative or scientific deficiencies through the portal; at that moment the clock stops and restarts when your response is uploaded. Response discipline decides your timeline.
5
Approval
The dual approval completes: the TİTCK suitability letter plus the ethics committee approval decision. Site initiation, IMP shipment (through a licensed depot) and enrollment can then begin.
6
Lifecycle management
Substantial amendments are approved before implementation; SUSARs are reported within 7/15 days; annual progress reports go to TİTCK and the ethics committee; close-out is notified.
Documents & Timelines
What goes in the dossier, how the clock runs
| Milestone | Typical timeline | Notes |
|---|---|---|
| Submission validation | On e-signature day | Finalised via KAM with e-signature; an unsigned submission is not official. |
| First review feedback | ~30–35 days | Typical target for standard pharmaceutical trials; ATMP and biosimilar studies may run longer. |
| Practical approval time | 4–6 weeks | Observed in practice for complete, consistent dossiers that receive no deficiency letter. |
| Deficiency response window | As stated in the letter | Typically ~30 days, extendable depending on the case; missed deadlines can end in rejection. |
| Ethics committee track | Concurrent with TİTCK | TİTCK waits for the positive ethics opinion before final permission; applying concurrently saves time. |
| Document | Language | Key note |
|---|---|---|
| Protocol + Turkish summary | EN accepted; summary in TR | Final ICH-GCP-compliant version; must be consistent with the ICF and brochure. |
| Investigator's Brochure (IB) | EN | Current edition; safety updates trigger amendments. |
| Informed Consent Form (ICF) | TR mandatory | All patient-facing material must be in Turkish; overly technical wording is a frequent rejection cause. |
| Clinical trial insurance policy | TR | Mandatory for commercial Phase I–IV trials; protects participants from trial-related injury. |
| GMP certificate & certificate of analysis | EN | An IMPD and EU QP release are not required in Türkiye — less dossier burden and a shorter start. |
| Trial budget + budget approval form | TR | Per TİTCK's budget format; should transparently cover ethics fees and logistics. |
| Investigator CVs | EN/TR | With GCP training records and experience; evidence of team competence. |
| Ethics committee proof / approval letter | TR | For parallel applications, proof of submission is uploaded; the approval is added once issued. |
Always verify the document set and formats against the current TİTCK guides (KAD-KLVZ-02/-03).
Ethics Committees
The dual lock: TİTCK suitability letter + ethics committee decision
TİTCK assesses scientific and regulatory suitability; the ethics committee assesses participant rights and safety — both approvals are required and run in parallel.
1
A dual-lock approval
Both the TİTCK suitability letter and the ethics approval are required; neither substitutes for the other.
2
Central assignment
Ethics pathways are centralised through TİTCK; sponsors are not left negotiating committee selection on their own.
3
Independent committees
Clinical Research Ethics Committees are independent bodies based at universities and Ministry of Health training-research hospitals.
4
Focus: participant rights
The committee scrutinises the ICF in detail; the risk-benefit balance, non-coercive participant payments and site adequacy carry the weight.
5
The governing guide
Ethics applications run under the KAD-KLVZ-03 guide and current forms; the process is tracked through the portal too.
The Omega difference: The same regulatory team runs ethics correspondence, ICF revisions and post-approval notifications — institutional memory never drops.
Our Ethics & Compliance approach
The Centre Landscape
Permitted Phase 1 and BA/BE capacity
Phase 1 Clinical Research Centres
TİTCK issues activity permits for Phase 1 centres and publishes the permitted list. Omega runs early-phase programmes on permitted Phase 1 capacity.
Bioavailability / Bioequivalence (BA/BE) Centres
BA/BE centres operate under TİTCK permits. Türkiye's strong generic and biosimilar ecosystem brings scale and speed to BA/BE programmes.
Ethics Committee & Centre Lists
TİTCK regularly publishes ethics committee lists and permitted centre information — the official basis for programme planning.
Permitted centre and ethics committee lists are published by TİTCK
The 2026 Agenda
The Turkish framework is updating — stay ahead of it
23 January 2026
Clinical Application Guideline update
A guideline update aligning trial conduct more tightly with international GCP expectations came into force.
14 November 2025
Trust (Reliance) Practices Guideline
When competent-authority GCP inspection reports are submitted, TİTCK does not run its own GCP inspection — the basis of faster, reliance-based approvals.
Through 2025
Investigator Meeting Guideline (Rev-02) and regulation amendment
Rev-02 took effect on 1 December 2025; the 5 June 2025 amendment updated licensing and record-retention processes.
15 December 2026
e-Ledger obligation
The e-Ledger transition completes for marketing authorisation holders — a key compliance date for sponsors and CROs operating in Türkiye.
Why Omega CRO
Not just readers of the guide — 29 years of walking this road
Since 1997
Türkiye's first CRO; offices in the US, Canada, Azerbaijan, Poland and Kosovo; 29 years of regulatory memory.
TİTCK + ethics submission experience
Submissions on KAP/KAM, deficiency responses, amendments, SUSAR XML reporting and annual reports — end-to-end regulatory operations.
Turkish documentation
ICFs and patient materials drafted in patient-readable Turkish by Regulatory Affairs and Medical Writing — closing the most frequent rejection cause.
Global compliance
With EU CTR 536/2014, CTIS notifications, FDA 21 CFR Part 11 EDC and ICH E6(R3)-aligned processes, Turkish data flows into your global dossiers seamlessly.
One roof
Central laboratory (HelixLab), licensed IMP depot (Omega Depot), pharmacovigilance, IWRS/EDC and home nursing (Omega Care) under one roof.
Scale
200+ full-time specialists; 50+ mid-to-large studies per year; 400+ investigator-initiated studies.
FAQ
Frequently Asked Questions
What is the difference between KAP and the Clinical Trials Module (KAM)?
KAP (kap.titck.gov.tr) is the public database holding records of trials within TİTCK's mandate — where you search authorised studies. KAM is the EBS-integrated submission module where applications are filed with e-signature and used across the trial lifecycle. In short: you submit through KAM; the visible record is tracked on KAP.
How long does TİTCK approval take?
For complete, consistent dossiers that receive no deficiency letter, practical approval is typically 4–6 weeks; first feedback for standard pharmaceutical trials targets ~30–35 days. When deficiencies are raised, the clock stops until your response is uploaded — response discipline therefore drives the timeline.
Do I need an IMPD or an EU QP release?
No. Turkish clinical trial applications require neither an IMPD nor an EU-style QP release document. The IMP's GMP certificate and certificate of analysis suffice — meaningfully lighter dossier preparation and a faster start.
Which documents must be in Turkish?
All patient-facing material — the informed consent form (ICF), patient brochure and digital engagement materials — must be in Turkish, as must the protocol summary. Scientific documents such as the protocol and investigator's brochure are accepted in English.
How does the ethics committee process work?
Türkiye uses a dual-lock system: both the TİTCK suitability letter and the ethics committee approval are required. The ethics review runs in parallel with TİTCK, committees are centrally assigned by TİTCK, and they are based at universities and Ministry of Health training-research hospitals.
What are the SUSAR reporting timelines?
Fatal or life-threatening SUSARs are reported to TİTCK within 7 days of the sponsor becoming aware; other SUSARs within 15 days. Foreign SUSARs involving the same investigational product are also in scope, submitted in structured format through the National SUSAR Module.
Does TİTCK accept foreign inspection reports?
Yes. Under the Trust Practices Guideline, GCP inspection reports issued by competent authorities such as FDA or EMA are accepted; absent violations of Turkish legislation, TİTCK does not run its own GCP inspection. Omega packages these reports into your TİTCK dossier — see our inspection readiness page for details.
Let us run this playbook for you
From the KAP/KAM submission to ethics approval, SUSAR reporting and the 2026 compliance calendar — we run Türkiye's regulatory process with 29 years of experience. In a 30-minute discovery call we'll map your programme's Türkiye roadmap.
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