dc.date.accessioned | 2020-07-09T18:28:52Z | |
dc.date.available | 2020-07-09T18:28:52Z | |
dc.date.created | 2020-01-30T16:20:08Z | |
dc.date.issued | 2019 | |
dc.identifier.citation | Bernabe, Rosemarie de la Cruz van Thiel, Ghislaine JMW Breekveldt, Nancy S Gispen, Christine C Van Delden, Johannes JM . Regulatory sanctions for ethically relevant GCP violations. Drug Discovery Today. 2019, 24(11), 2116-2119 | |
dc.identifier.uri | http://hdl.handle.net/10852/77698 | |
dc.description.abstract | Although EU inspectors and clinical assessors are mandated to identify and act upon ethical issues, regulators lack guidance on how this can be done. Hence, we propose a four-step regulatory approach on ethically relevant GCP violation findings. The first step is identification of the ethical issue. Next is analysis [i.e., identifying the gravity (intensity or severity) and the magnitude (amount and duration) of the ethics violation as well as the responsible person(s) or entity or entities]. The third step is evaluation, (i.e., the process of deliberating to determine the significance of the ethics violation, with the intention of identifying the most reasonable sanction and/or corrective or reparative action). Last is decision-making or the process of choosing and implementing a regulatory course of action. | en_US |
dc.language | EN | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Regulatory sanctions for ethically relevant GCP violations | en_US |
dc.type | Journal article | en_US |
dc.creator.author | Bernabe, Rosemarie de la Cruz | |
dc.creator.author | van Thiel, Ghislaine JMW | |
dc.creator.author | Breekveldt, Nancy S | |
dc.creator.author | Gispen, Christine C | |
dc.creator.author | Van Delden, Johannes JM | |
cristin.unitcode | 185,52,13,0 | |
cristin.unitname | Senter for medisinsk etikk | |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |
dc.identifier.cristin | 1786990 | |
dc.identifier.bibliographiccitation | info:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Drug Discovery Today&rft.volume=24&rft.spage=2116&rft.date=2019 | |
dc.identifier.jtitle | Drug Discovery Today | |
dc.identifier.volume | 24 | |
dc.identifier.issue | 11 | |
dc.identifier.startpage | 2116 | |
dc.identifier.endpage | 2119 | |
dc.identifier.doi | https://doi.org/10.1016/j.drudis.2019.07.001 | |
dc.identifier.urn | URN:NBN:no-80807 | |
dc.type.document | Tidsskriftartikkel | en_US |
dc.type.peerreviewed | Peer reviewed | |
dc.source.issn | 1359-6446 | |
dc.identifier.fulltext | Fulltext https://www.duo.uio.no/bitstream/handle/10852/77698/2/Regulatory%2Bsanctions%2Bfor%2Bethically%2Brelevant%2BGCP%2Bviolations.pdf | |
dc.type.version | PublishedVersion | |