Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 11 Essential Guide to the EU Clinical Trial Regulation This online, on-demand course covers in more depth the main content and requirements of the EU Clinical Trial Regulation (CTR). The course is interactive and takes around 1 hour. It also contains questions as an integral part of the course to check knowledge gained. Content includes: • Structure of the CTR and supporting guidelines • The Clinical Trial Information System (CTIS) – what is it? Functionality of the CTIS • Interventional, non-interventional and low interventional trials EU CTR • Authorization of a clinical trial – a single application • Notifications and templates • Substantial and non-substantial modifications • Conditions for conducting a clinical trial • Site suitability statement • Additional informed consent requirements • Consent for vulnerable patients • Safety reporting • Serious breach reporting • Urgent safety measures • Summary of trial results • Trial Master File and document retention. All of our CTR courses come with a link to our unique online bookshelf which contains useful documents relating to the CTR. This bookshelf is updated regularly and participants of courses have ongoing access to this. For details of packages for training larger groups contact us at info@brookwood-global.com The EU Clinical Trial Regulation It is important that both sponsors and investigators are aware of the requirements of the EU Clinical Trial Regulation 2014 No 536. Our four online courses offer training: • for those needing a high-level overview • for those needing more in-depth knowledge • for investigator site members who need awareness of how the CTR changes their responsibilities and working practices. FLAGSHIP ONLINE COURSE www.brookwood-global.com info@brookwood-global.com Stats COMING SOON Our new range of courses in Clinical Statistics GMP Stats
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