An overview of planning and running NIS studies.

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.