Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP CTR for ALL – a high-level overview of the EU CTR This 15-20 minute course is ideal for those needing a short, high-level introduction to the EU CTR. It covers the main changes to working practices and highlights some of the new important requirements. Content includes: • When the CTR applies. • What the CTR brings that’s new. • Heads-up on the new trial authorization process. • Significant changes to trial conduct. • Modifications, notifications and reports. • How the CTR affects the Trial Master File. EU CTR Click for product demo 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. EU CTR Click for product demo Managing and Reporting Serious Breaches of the EU CTR This 30-minute, on-demand course overviews the requirements of the EU Clinical Trial Regulation (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. EU CTR Click for product demo
RkJQdWJsaXNoZXIy ODI0NjI3