ATMP - Clinical Trials Information System (CTIS)

Clinical Trials Information System (CTIS) (CTIS)

Clinical Trials Information System [ENGLISH]

CTIS (Clinical Trials Information System) is an EU-wide web portal and database for clinical trials where applications are submitted. The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission.

Clinical Trials Information System (CTIS) [SWEDISH]

CTIS (Clinical Trials Information System) är en EU-gemensam webbportal och databas för kliniska prövningar där ansökningshandlingar skickas in.

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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