klinik araştırma
clinical trial
A scientific evaluation of medicinal products in humans, conducted with TİTCK and ethics committee approval.
TİTCK RG 32203 md.3 · EU CTR 536/2014 md.2
TİTCK RG 32203 · EU CTR 536/2014 · ICH E6(R3)
Regulatory Glossary
The canonical terminology we use across our clinical research content. Every term is aligned with the Turkish Clinical Trials Regulation (RG 27.05.2023/32203) and EU Regulation 536/2014.
araştırma merkezi
trial site
The center where a clinical trial is conducted under the investigator’s responsibility.
TİTCK RG 32203 md.3 · ICH GCP 1.71
İİÜ — Araştırma Amacıyla Kullanılan Tıbbi Ürün
investigational medicinal product (IMP)
A medicinal product being tested or used as a reference, including placebo, in a clinical trial.
TİTCK RG 32203 md.3 · EU CTR 536/2014 md.2
esaslı değişiklik
substantial modification
Any change to an authorised trial dossier with significant impact on participant rights, safety or wellbeing, or on trial conduct; requires ethics and TİTCK approval.
TİTCK RG 32203 md.3 · EU CTR 536/2014 md.2
ciddi ihlal
serious breach
Non-compliance with a significant impact on participant safety/rights or data integrity; triggers expedited reporting.
EU CTR 536/2014 md.2 · TİTCK
Şüphelenilen Beklenmeyen Ciddi Advers Reaksiyon (SUSAR)
suspected unexpected serious adverse reaction (SUSAR)
A serious, unexpected adverse reaction suspected to be related to the IMP; reported within 7/15 days via the National SUSAR Module.
EU CTR 536/2014 md.2 · TİTCK Ulusal SUSAR Modülü duyurusu (2026)
bilgilendirilmiş gönüllü olur formu (BGOF)
informed consent form (ICF)
The form informing the volunteer and documenting freely-given participation; must be in Turkish.
TİTCK RG 32203 md.3 · ICH GCP 1.28
katılımcı (gönüllü)
participant (volunteer)
An individual who takes part in a clinical trial on the basis of informed consent.
ICH GCP 1.57-1.58 · TİTCK RG 32203
destekleyici
sponsor
The individual or company responsible for the initiation and management of a trial.
TİTCK RG 32203 md.3 («destekleyici») · EU CTR 536/2014 md.2
araştırmacı
investigator
The physician responsible for the conduct of the trial at a site (principal investigator) or a team member.
TİTCK RG 32203 md.3 · EU CTR 536/2014 md.2
etik kurul
ethics committee
An independent body protecting participant rights and safety; centrally assigned by TİTCK.
TİTCK RG 32203 md.3 · EU CTR 536/2014 md.2
tetkik
audit
A sponsor’s or CRO’s internal/vendor quality review — not a regulatory authority action. (Retired the legacy İKU Dergisi translation “denetleme”.)
ICH GCP 1.6
denetim izi
audit trail
A secure, computer-generated record tracking who changed what and when in electronic records.
FDA 21 CFR Part 11 · İKU
denetim
inspection
A GCP inspection by a competent authority (TİTCK/FDA/EU member state).
TİTCK Risk Bazlı GCP Denetimleri Kılavuzu
izleme
monitoring
The sponsor’s oversight of trial conduct, data collection and reporting.
ICH GCP 1.38 · İKU
İyi Klinik Uygulamaları (İKU)
good clinical practice (GCP)
The international ethical and scientific quality standard for designing, conducting and reporting trials.
ICH E6(R3)
farmakovijilans
pharmacovigilance
The science of collecting, monitoring, assessing and acting on drug safety data.
GVP · TİTCK
biyoeşdeğerlik
bioequivalence
Studies demonstrating similar bioavailability of test and reference products at the same molar dose.
TİTCK BY/BE Kılavuzu
AB Klinik Araştırmaları Yönetmeliği (536/2014)
Regulation (EU) No 536/2014 (CTR)
The EU regulation governing the authorisation and supervision of clinical trials.
EU CTR 536/2014
CTIS — Klinik Araştırma Bilgi Sistemi
CTIS (Clinical Trials Information System)
The single EU portal for trial applications and result reporting (EMA).
EMA · EU CTR 536/2014
KAP — Klinik Araştırma Portalı
KAP (Clinical Trials Portal)
TİTCK’s public database of records for clinical trials within its mandate.
TİTCK (titck.gov.tr/kap)
KAM — Klinik Araştırma Modülü
Clinical Trials Module (KAM)
The EBS-integrated, e-signed trial submission module used across the trial lifecycle.
TİTCK · EBS (ebs.titck.gov.tr)
Yıllık Güvenlilik Raporu (DSUR)
Development Safety Update Report (DSUR)
The annual safety summary for an investigational product (ICH E2F); distinct from the annual progress report.
ICH E2F · TİTCK
advers reaksiyon
adverse reaction
A harmful, unintended response for which a causal relationship with the product is at least a reasonable possibility.
TİTCK SUSAR duyurusu (2026) · ICH E2A
düşük müdahaleli klinik araştırma
low-intervention clinical trial
A trial where an authorised product is used per SmPC and additional procedures do not exceed routine practice.
EU CTR 536/2014 md.2
katılımcı kaydı (gönüllü alımı)
enrollment (recruitment)
The process of including eligible participants in a trial.
ICH GCP
dağıtık klinik araştırma
decentralized clinical trial
A trial model where part of the processes run outside the site (at home, via digital tools).
EMA/HMA recommendation paper · ICH E6(R3) Annex 2
TİTCK — Türkiye İlaç ve Tıbbi Cihaz Kurumu
TİTCK (Turkish Medicines and Medical Devices Agency)
The national competent authority under the Ministry of Health.
titck.gov.tr
Подходящие термины не найдены.
How is this glossary maintained?
This glossary is the public face of the controlled vocabulary used across our Türkiye Regulatory Hub guide and all legislation commentary articles. Terms are updated as regulations change.
The Türkiye Clinical Trial Regulatory Hub →