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20:14 Nov 4, 2014 |
English to Dutch translations [PRO] Medical - Medical (general) / research | |||||||
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| Selected response from: Ron Willems Netherlands Local time: 22:47 | ||||||
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2 | onderzoeksleider |
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UK |
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Discussion entries: 5 | |
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chief investigator onderzoeksleider Explanation: dit klinkt me redelijk in de oren, maar ik weet niet of het ook in deze specifieke context wordt gebruikt. PS site = centrum, meen ik |
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58 mins peer agreement (net): +1 |
Reference: UK Reference information: Chief Investigator A senior individual must be designated as the Chief Investigator for any research undertaken in or through the NHS or social services, which involves participants or their organs, tissue or data. Main responsibilities: •The Chief Investigator is the individual who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the Chief Investigator takes responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the lead at each site Principal Investigator The Principal Investigator is the person responsible individually, or as the leader of researchers at a particular site, for the conduct of a study. Main responsibilities: •submit proposals for ethical review •obtain Sponsorship approval •conduct research according to agreed protocol & in accordance with legal requirements •ensure participant welfare •record keeping •adverse event reporting •dissemination of results http://www.cardiff.ac.uk/racdv/resgov/governance/responsibil... -------------------------------------------------- Note added at 1 hr (2014-11-04 21:28:27 GMT) -------------------------------------------------- The Chief Investigator This is the person with overall responsibility for the research and all COREC applications must be submitted by the Chief Investigator. The Principal investigator/Local Leads A senior individual must be designated as the principal investigator for each site where research is undertaken in or through the NHS or when using NHS patients’ organs, tissue or data. The Principal investigator will take responsibility for the conduct of the research at their site and is accountable for this to their employer, and, through them, to the sponsor of the research and to the care organisation(s) within which the research takes place, or through which participants, their organs, tissue or data are accessed. http://www.kirklees.nhs.uk/uploads/tx_galileodocuments/Chief... -------------------------------------------------- Note added at 2 hrs (2014-11-04 22:19:27 GMT) -------------------------------------------------- Welke stappen moeten worden doorlopen om het UMC Utrecht als deelnemend centrum toe te voegen aan een onderzoek dat door een andere METC is beoordeeld? 1. Onderzoeksverklaring ◦ Als het UMC Utrecht lokaal deelnemend centrum is, wordt door de lokale onderzoeker via het afdelingshoofd een onderzoeksverklaring (OV) aangevraagd. ◦ De OV moet samen met de lokaal te gebruiken documenten door de onderzoeker naar de centrale hoofdonderzoeker gestuurd worden, ter beoordeling aan de Toetsende Commissie (TC). ◦ Het besluit van de TC over deelname van het UMC Utrecht gaat naar de centrale hoofdonderzoeker. Deze stelt de lokale onderzoeker in het UMC Utrecht hiervan op de hoogte met een kopie van het besluit. ◦ De lokale onderzoeker vraagt de RvB van het UMC Utrecht via het METC-secretariaat toestemming voor uitvoering in het UMC Utrecht (zie stap 2). ◦ Daarop kan de RvB schriftelijk toestemming geven aan de lokale onderzoeker om het onderzoek in het UMC Utrecht uit te voeren, wat voorwaarde is om de studie te mogen starten (zie stap 2). http://www.umcutrecht.nl/nl/Subsites/Medisch-Ethische-Toetsi... |
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Note to reference poster
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