Non-interventional studies - Practical Aspects

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.

Click here to see our Introductory video

For details of packages for training larger groups contact us at info@brookwood-global.com

Click here for brochure

 

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