ATMP - prövningsprotokoll (SE ÄVEN STUDIEPROTOKOLL?)

prövningsprotokoll (SE ÄVEN STUDIEPROTOKOLL?)

trial protocol [ENGLISH]

An agreed plan issued by the sponsor of a clinical trial giving details of the objectives, design and organisation of the study.

prövningsprotokoll (SE ÄVEN STUDIEPROTOKOLL?) [SWEDISH]

Dokument som beskriver vilka syften den kliniska prövningen har, hur den är utformad och vilken metod som ska användas samt vilka statistiska överväganden som gjorts och hur prövningen är upplagd. Termen prövningsprotokoll inbegriper senare versioner och ändringar av prövningsprotokollet.

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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