GCP E6(R3) Training + Certificate in Polish
150,00 zł Seller exempt from VAT – gross prices equal net prices (Article 113 of the VAT Act)
TRANSCELERATE CERTIFICATION We are proud to announce that our training meets the minimum requirements specified on the TransCelerate website. As a result, the certificate of completion of our training is recognized by Sponsors. Each participant, after completing the course and meeting the passing requirements, will receive a personalized certificate of course completion. COURSE STRUCTURE The training consists of 9 modules:
- Introduction
- Meet the Team
- Site Activation
- First Patient and Informed Consent
- SAE Alert!
- Monitoring Visit
- Audit and Site Closure
- Data Governane
- GCP R3 Glossary
Dodatkowo: Spis różnic GCP R2 a R3 oraz Skrypt dopasowań slajdów do ICH E6(R3) Szkolenie przeprowadzi Cię przez zasady GCP na różnych etapach trwania badania. W praktyce poznasz zastosowanie zasad GCP! WHY IS IT WORTH IT?
- A WELL-DESIGNED STRUCTURE
6 modules guide the participant through the entire lifecycle of a clinical trial, from study start-up to site closure.
- EACH MODULE COMBINES THEORY WITH PRACTICE
discussing the 11 GCP R3 principles through concrete, real-life examples from a clinical research site: situations related to patient recruitment, informed consent, monitoring, event reporting, and audits. This way, participants not only learn the regulations but also see how the ICH GCP R3 principles function in everyday practice and how they support participant protection and data quality.
Marcel Stelmasiak –
The GCP R3 course is a well-designed training: up-to-date, clear, and practical. The materials clearly explain the changes introduced in ICH E6 R3 and allow you to quickly update your knowledge. The certificate of completion confirms your familiarity with the latest clinical research standards. I recommend it to anyone who works or plans to work in this field.
gmarcisz –
I recommend the GCP E6(R3) course created by ClinicalTrials4U. The course is prepared in a very accessible format and allows you to understand the responsibilities of all individuals and institutions involved in conducting a clinical trial—from study start-up to site closure. It also includes practical examples of situations and issues, along with suggested solutions.
Another advantage of the training is the presentation of the differences between GCP R2 and GCP R3, which makes the course suitable both for individuals who are just starting their work in clinical research and for those who already have experience in the field.
Karina Chmielarz-Sikorska (verified owner) –
Great course! At first glance it may seem extensive, but it truly covers the most important issues that everyone should know. Its biggest advantage is the references to everyday professional situations, as well as the highlighted changes and comparisons to previous versions of GCP. I recommend it to monitors, coordinators, and study site teams alike.
Marzena Czyżowicz (verified owner) –
The training is professional, clear, and aligned with current standards. The platform works seamlessly, and the online format allows you to learn quickly and efficiently at your own pace. Phone support is friendly and helpful. I highly recommend ClinicalTrials4U as a reliable training provider.
wmarchocka@gmail.com –
Treść kursu została przekazana w bardzo przystępny i zrozumiały sposób. Szczególnym
udogodnieniem było dodatkowe wyjaśnienie poszczególnych zagadnień, które nie zawsze
mogły być do końca czytelne.
Scenki z ośrodka klinicznego prezentujące autentyczne sytuacje mające miejsce w toku badań
są według mnie najlepszym sposobem na pokazanie kursantowi jak wygląda praca w branży.
Świetnym krokiem było przesunięcie teorii na dalszy plan na rzecz aspektów praktycznych.
Ukończenie kursu gwarantuje nie tylko certyfikat, ale i poczucie posiadania niezbędnej w
branży badań klinicznych wiedzy, co jest według mnie wartością bezcenną.
W moim odczuciu kurs przebiegł ekspresowo, a co najważniejsze, owocnie – pozytywny
wynik testu uzyskałam szybko i bezboleśnie.