Drug Development & Regulation

Good Clinical Practice GCP

TRİyi Klinik Uygulamalar
Also known as:ICH-GCP · ICH E6

An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials, ensuring that participants' rights, safety and well-being are protected and that trial data are credible.

In depth

GCP is codified in the ICH E6 guideline and rooted in the ethical principles of the Declaration of Helsinki. Core requirements include prior ethics committee approval and regulatory authorization, freely given informed consent, qualified investigators, a protocol and quality management system maintained by the sponsor, monitoring and audit, accurate source documentation, protection of confidentiality and timely reporting of serious adverse events.

In Turkey, clinical trials of medicines require ethics committee approval and authorization by TİTCK, and GCP principles are incorporated into national regulations and guidance.

Clinical pearl

Pharmacists in trial units have GCP-defined responsibilities for investigational products: storage, dispensing, accountability records and maintenance of the blind.

TRIn Turkish

İyi Klinik Uygulamalar

Klinik araştırmaların tasarlanması, yürütülmesi, kaydedilmesi ve raporlanmasına yönelik uluslararası etik ve bilimsel kalite standardıdır; gönüllülerin haklarının, güvenliğinin ve esenliğinin korunmasını ve araştırma verilerinin güvenilirliğini sağlar.

İKU, ICH E6 kılavuzunda tanımlanmıştır ve Helsinki Bildirgesi'nin etik ilkelerine dayanır. Temel gereklilikler arasında etik kurul onayının ve düzenleyici otorite izninin önceden alınması, özgür iradeyle verilmiş bilgilendirilmiş onam, yetkin araştırmacılar, destekleyici tarafından sürdürülen protokol ve kalite yönetim sistemi, izleme ve denetim, doğru kaynak belgeleme, gizliliğin korunması ve ciddi advers olayların zamanında bildirilmesi yer alır.

Türkiye'de ilaç klinik araştırmaları etik kurul onayı ve TİTCK izni gerektirir; İKU ilkeleri ulusal mevzuata ve kılavuzlara aktarılmıştır.

Araştırma birimlerindeki eczacıların araştırma ürünlerine ilişkin İKU kapsamında tanımlı sorumlulukları vardır: saklama, dağıtım, ürün sayım ve takip kayıtları ile körlüğün korunması.

Diğer adları:İKU · İyi Klinik Uygulamaları
Updated 24.09.2026 0 views Educational reference — verify against current sources before clinical use.

Read next

Informed ConsentBilgilendirilmiş Onam

A person's voluntary agreement to take part in research or to undergo treatment, given after receiving and understanding adequate information about its purpose, procedures, risks, benefits and alternatives.

 Phase I Clinical TrialFaz I Klinik Araştırma

The first stage of testing an investigational drug in humans, usually in a small number of healthy volunteers, designed mainly to assess safety, tolerability, pharmacokinetics and, where possible, pharmacodynamics.

 Randomized Controlled TrialRandomize Kontrollü Çalışma

A prospective experimental study in which participants are allocated by chance to an intervention or a control (placebo, usual care or an active comparator) and followed up to compare outcomes.

 Serious Adverse EventCiddi Advers Olay

An adverse event that results in death, is life-threatening, requires or prolongs hospitalisation, causes persistent or significant disability, is a congenital anomaly, or is otherwise medically important.

 Good Manufacturing Practiceİyi İmalat Uygulamaları

The part of pharmaceutical quality assurance that ensures medicines are consistently manufactured and controlled to the quality standards appropriate to their intended use and required by the marketing authorization.

 Adverse EventAdvers Olay

Any untoward medical occurrence in a patient or clinical-trial subject given a medicinal product, whether or not it is considered causally related to the treatment.