Brookwood Global Products Brochure 2020

• KEY FACTS • To evaluate the training, contact us by email info@brookwood-global.com @ NIS, Practical Aspects (Module 2) Content includes: • Setting up and running NIS • Planning • Impact of EU and US requirements • Choosing a design • Role of SCOPE; GRACE principles • Cross-sectional, case-control and cohort studies • Protocol content and development • Declaration of Helsinki and NIS • ENCePP guidance • Study milestones • Consent in NIS • Study conduct • Analysis of data • Codes of conduct and agreements • Scientific independence • Monitoring • MAH oversight obligations • NIS and safety reports; risk management plans • Data privacy • Study report • Publication of results • Training • Documentation and archives • Glossary of terms • Short quiz Designed around an air journey to different parts of the real world to learn about key elements of running NIS. NIS