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blindning

blinding [ENGLISH]

Procedure in which one or more parties involved in the trial (potentially including trial participants) are kept unaware of which study arm each participant has been assigned to.

blindning [SWEDISH]

Procedur inom randomiserade kliniska studier där studiepersonal och de som arbetar med datainsamling, validering och analys av studieresultatet samt i vanliga fall studiedeltagarna hålls ovetande om vilken av behandlingsalternativen som studiedeltagaren ges. Blindningen bryts efter det att studieutfallet analyseras. Syftet med blindning är att renodla experimentet och reducera risk för bias i tolkningen av utfallet.

2024-01-29

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 https://www.asgct.org/education/more-resources/glossary
  2. 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. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  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 https://toolkit.ncats.nih.gov/glossary-2/

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