Contact us directly for the best group rates. info@brookwood-global.com • ONLINE TRAINING • GCLP Regs RM MD NIS CDM PV GDPR GCP Non-interventional Studies, General Principles (Module 1) Interactive, personalized, narrated and readonly tracks, suitable for both inexperienced and experienced staff. Provides a generic core basic training (takes approx. 35 mins). Content includes: • What are non-interventional studies (NIS)? • Why perform NIS? • Definition of NIS • Declaration of Helsinki • Rules governing NIS • Data protection • Requests by regulators • PAS, PASS, PAES explained • NIS in pharmacovigilance • Pharmacovigilance inspections • Abbreviations explained • Glossary of terms • Short quiz. NIS Click for product demo NIS, Practical Aspects (Module 2) Designed around an air journey to different parts of the real world to learn about key elements of running NIS. 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. NIS Click for product demo NIS Essentials for Investigators This training provides an understanding of the general obligations of researchers when undertaking NIS. Topics include: • Definition of non-interventional • Types of study • Key factors affecting NIS • Ethics and consent • Health authority approval • Data privacy • Protocol and its content • Current medical practice • Safety data collection • Study contracts • Data access • Study reports • Publication of results • Glossary of terms and abbreviations • Short quiz. NIS Click for product demo
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