PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research · SOCIAL QUESTIONS|health|medical science
- imscrúdú cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- klinische Untersuchung | klinische Prüfung
- de
- Definition systematische Untersuchung an einem oder mehreren menschlichen Probanden, die zwecks Bewertung der Sicherheit oder Leistung eines Produkts durchgeführt wird Reference Vorschlag für eine Verordnung über Medizinprodukte, Art.2 Nr.33; COM(2012)0542 final CELEX:52012PC0542/DE
- Comment entspricht der klinischen Prüfung (EN clinical trial) bei Arzneimitteln IATE:1686971 ; NICHT dasselbe wie "klinische Bewertung" (EN "clinical evaluation") IATE:3545137
- clinical investigations | clinical investigation
- en
- Definition any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device Reference Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices [..], CELEX:32017R0745/EN
- Comment Please note that in general usage, clinical investigation is a broader concept which in addition to medical devices covers also, e.g. in the USA, investigational new drug and investigational device exemption studies. Ref.: a) FDA. Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf [11.6.2012] b) FDA. Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER) http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/InvestigationalNewDrugINDorDeviceExemptionIDEProcess/default.htm [11.6.2012] c) FDA. Device Advice: Investigational Device Exemption (IDE) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm [11.6.2012]
- investigation clinique
- fr
- Definition toute investigation systématique impliquant un ou plusieurs participants humains destinée à évaluer la sécurité ou les performances d'un dispositif Reference Règlement (UE) 2017/745 relatif aux dispositifs médicaux (art. 2, point 45)