Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 7 • ONLINE TRAINING • GCP Refresher for Sponsors This GCP refresher course for sponsors and service providers is an interactive quiz game with 55 questions. Takes around 45 minutes. • This course is for those who have previously undertaken comprehensive E6(R3) training and are now in need of a refresher. The course is not a substitute for basic training in E6(R3) • Questions cover a wide range of GCP topics based on ICH E6(R3) Principles and Annex I • 11 levels of slightly increasing difficulty – complete them all to pass • 5 questions at each level – must get 4 correct to proceed (80%) • Feedback given for incorrect answers, with opportunity to review and repeat the level • Compulsory ‘Did You Know?’ sections to enhance learning • Resources to read form part of the course. GCP GCP GCP GCP has changed – what’s new in ICH E6(R3) This 45-minute online course aims to update sponsor and service provider personnel who already have current GCP training in place. It covers the new requirements introduced by the latest E6(R3) Annex 1 guideline. It emphasizes the need for a risk proportionate approach to trial management that focuses on the rights, safety and well-being of participants and the reliability of trial data. It identifies some of the trickier new requirements faced by sponsors, service providers and investigators. GCP for All Administrators, assistants, documentation specialists and other non-technical staff might not need to know GCP in all its detail, they should be aware of the principles that facilitate participant protection, the collection and reporting of reliable clinical trial data and the maintenance of essential records. GCP for All provides the basic training they will need. • Short, quick and easy to read course covers the key principles that non-technical staff should be aware of. • Aims to enhance GCP knowledge at a basic level and highlight key principles. • Links are given in resources to a bookshelf containing the ICH E6(R3) guidelines and two booklets covering the Principles and GCP and the Declaration of Helsinki TransCelerate 4 4 For details of packages for training larger groups contact us at info@brookwood-global.com
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