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EudraCT (EudraCT)

European Union Drug Regulating Authorities Clinical Trials [ENGLISH]

The European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC. EMA Glossary of Regulatory Terms: A database that includes information on clinical trials taking place in the European Union and clinical studies conducted worldwide in accordance with a paediatric investigation plan. A subset of the data is publicly accessible via the European Clinical Trials Register.

EudraCT [SWEDISH]

The European Clinical Trials Database över alla interventionella kliniska prövningar av läkemedel som börjar i Europeiska unionen från 1 maj 2004 och framåt. EudraCT-databasen har upprättats i enlighet med direktiv 2001/20/EC. EMA:s ordlista med regulatoriska termer: En databas som innehåller information om kliniska prövningar som äger rum i Europeiska unionen och kliniska studier som genomförts över hela världen i enlighet med en pediatrisk undersökningsplan. En delmängd av data är allmänt tillgänglig via European Clinical Trials Register.

2024-01-29

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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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