ATMP - certifierat referensmaterial

certifierat referensmaterial (CRM)

certified reference material [ENGLISH]

Reference material with one or more specific properties that have been characterized using a metrologically valid procedure, accompanied by a certificate issued by an authoritative body that reports the specified property values with associated uncertainties and traceabilities.

certifierat referensmaterial [SWEDISH]

Referensmaterial med en eller flera specifika egenskaper som har karakteriserats med hjälp av ett metrologiskt giltigt förfarande, åtföljt av ett certifikat utfärdat av ett auktoritativt organ som redovisar de angivna egenskapsvärdena med tillhörande osäkerheter och spårbarhet.

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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