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non-interventional study [ENGLISH]

Type of observational study in which the participant is prescribed the medicinal product as usually permitted in the terms of the marketing authorization, in order to evaluate the product’s effectiveness, safety and tolerability under real-life conditions.

icke-interventionsstudie [SWEDISH]

Med icke-interventionsstudier avses alla studier och projekt som inte är kliniska pröv­ningar enligt Läkemedelsverket. I en icke-interventionsstudie inkluderas patienter baserade på ett eller flera urvalskrite­rier, t.ex. efter diagnos eller vilken behandling de står på.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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