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datamonitoreringskommitté (DMC)

Data Monitoring Committee [ENGLISH]

An independent group of experts that monitors the conduct, safety and validity of an ongoing clinical trial through a periodic review of unblinded data from the trial, and advises the trial sponsor throughout on whether the trial should be continued, modified or ended.

datamonitoreringskommitté [SWEDISH]

Oberoende expertgrupp som övervakar/utvärderar och säkerställer säkerheten och effektivitet av den inventention som ges samt förfarandet av en klinisk studie. Ger fortlöpande rekommendationer till studiens sponsor avseende avbrytande, paus eller fortsättande av studien utifrån tillgängliga data.


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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