allvarlig oönskad händelse

allvarlig oönskad händelse (SAE)

serious adverse event [ENGLISH]

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

allvarlig oönskad händelse [SWEDISH]

Avvikelser i hälso- och sjukvården kan vara av olika karaktär och allvarlighetsgrad. Det kan handla om allt från mindre störningar i det dagliga arbetet som inte leder till att patienter skadas, till händelser som medför en vårdskada där patienten avlider.

2024-01-29

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Resources and references

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

1. American Society of Gene and Cell Therapy Glossary https://www.asgct.org/education/more-resources/glossary
2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
9. Toolkit For Patient Focused Therapy Development Glossary https://toolkit.ncats.nih.gov/glossary-2/

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