Contact us directly for the best group rates. info@brookwood-global.com • ONLINE TRAINING • GCLP Regs RM MD NIS CDM PV GDPR GCP EU CTR Click for product demo EU CTR Click for product demo EU CTR Click for product demo Essential Guide to the EU CTR This 1-hour, on-demand course covers in more depth the main content and requirements of the EU CTR. Content includes: • Structure of the CTR and supporting guidelines • The Clinical Trial Information System (CTIS) • Interventional, non-interventional and low interventional trials • Authorization of a clinical trial • Notifications and templates • Substantial and non-substantial modifications • Site suitability statement • Informed consent requirements • Safety reporting • Serious breach reporting • Urgent safety measures • Summary of trial results • Trial Master File and document retention. Clinical Investigator Site Awareness: the EU CTR This short 20-minute course provides investigators and members of their team with a heads-up on what clinical trial staff need to know about the CTR. It highlights what is new and different, and what has changed from the previous EU requirements. Content includes: • Why the EU introduced the CTR • Scope of the CTR • New requirements relating to trial conduct • New consent requirements • Serious breaches and urgent safety measures • Changes to safety reporting requirements • Pre-trial information requirements • Retention of essential documents • Risk proportionate approaches to clinical trials • Changes for the sponsor. Managing and Reporting Serious Breaches of the EU CTR This 30-minute, on-demand course overviews the requirements of the CTR and the content of the European Medicines Agency guideline relating to the management and reporting of serious breaches of the Regulation, protocol and GCP. This training is suitable for all those involved in clinical trials in humans who may encounter a serious breach, including both sponsors and investigator site personnel, whether based in Europe or elsewhere. Content includes: • What is a reportable serious breach? • Definition of serious breaches: what the key words mean • Who should make a report and when • Examples of serious and non-serious breaches • Responsibilities of vendors and investigators.
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