Non-interventional studies - Practical Aspects

Non-interventional studies - Practical Aspects
Product Code: Practical Aspects - Non-interventional studies
Availability: In Stock
Price: £80.00

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* Non Interventional Studies:



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Non-interventional studies, Practical Aspects (Module 2) – interactice, personalized, narrated and read-only tracks ideal for those who need a generic but more in-depth knowledge of running NIS (takes approx. 45 mins)

Fantastic rates available for groups of 5 or more participants - contact us for details

Content includes

  •  Setting up and running non-interventional studies
  •  Planning
  •  Impact of EU, 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
  •  Analysis of data
  •  Study conduct
  •  Codes of conduct, 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
  •     Short Quiz

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