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misstänkt oväntad biverkning (SUSAR)

suspected unexpected adverse drug reaction [ENGLISH]

Unexpected incident that is suspected to be associated with the acquisition, testing, processing, storage or distribution of cells or tissues that, at any dose, could result in death or life-threatening, disabling or incapacitating illness, the transmission of communicable disease or might result in, or prolong, hospitalization.

misstänkt oväntad biverkning [SWEDISH]

Oväntad incident som misstänks vara associerad med förvärv, testning, bearbetning, lagring eller distribution av celler eller vävnader som, oavsett dos, kan resultera i dödsfall eller livshotande, invalidiserande eller invalidiserande sjukdom, överföring av smittsamma sjukdomar eller kan leda till, eller förlänga, sjukhusvistelse.


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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