GCP E6(R3) Training + Certificate (English language)

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 issued after our training is recognized by Sponsors. Each participant, upon completing the course and meeting the passing requirements, will receive a personalized certificate of completion. COURSE STRUCTURE The training consists of 9 modules: Introduction Meet the Team Site Activation First Patient and Informed Consent Attention SAE! Monitoring Visit Audit and Site Closure Data Governance GCP R3 Glossary Additionally: A list of differences between GCP R2 and R3, and a slide alignment script with ICH E6(R3). The training will guide you through the GCP principles at different stages of a clinical trial. In practice, you will learn how GCP principles are applied! WHY IS IT WORTH IT? THOUGHTFUL STRUCTURE 6 modules guide the participant through the entire life cycle of a clinical trial, from study start-up to site closure. EACH MODULE COMBINES THEORY WITH PRACTICE by discussing the 11 principles of GCP R3 using specific, real-life examples from clinical research sites: situations related to patient recruitment, informed consent, monitoring, event reporting, and audits. This way, participants not only learn the regulations but also see how ICH GCP R3 principles work in daily practice and how they support participant protection and data quality.