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dc.contributor.authorMagnin, Anette
dc.contributor.authorIversen, Valentina Cabral
dc.contributor.authorCalvo, Gonzalo
dc.contributor.authorCecetkova, Beata
dc.contributor.authorDale, Ola
dc.contributor.authorDemlova, Regina
dc.contributor.authorBlasko, George
dc.contributor.authorKeane, Fionnuala
dc.contributor.authorKovács, Gabor G.
dc.contributor.authorLevy-Marchal, Claire
dc.contributor.authorMonteiro, Emilia
dc.contributor.authorPalmisano, Lucia
dc.contributor.authorPella, Daniel
dc.contributor.authorPortoles, Antonio
dc.contributor.authorRascol, Olivier
dc.contributor.authorSchmied, Caecilia
dc.contributor.authorTay, Fabian
dc.contributor.authorvon der Leyen, Heiko
dc.contributor.authorOhmann, Christian
dc.date.accessioned2020-02-19T07:32:23Z
dc.date.available2020-02-19T07:32:23Z
dc.date.created2020-01-16T09:07:28Z
dc.date.issued2019
dc.identifier.citationTrials. 2019, 20 616-?.nb_NO
dc.identifier.issn1745-6215
dc.identifier.urihttp://hdl.handle.net/11250/2642429
dc.description.abstractBackground Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. Methods To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. Results The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. Conclusions There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.nb_NO
dc.language.isoengnb_NO
dc.publisherBioMed Centralnb_NO
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleEuropean survey on national training activities in clinical researchnb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.description.versionpublishedVersionnb_NO
dc.source.pagenumber616-?nb_NO
dc.source.volume20nb_NO
dc.source.journalTrialsnb_NO
dc.identifier.doi10.1186/s13063-019-3702-z
dc.identifier.cristin1774368
dc.description.localcodeOpen Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.nb_NO
cristin.unitcode194,65,35,0
cristin.unitcode194,65,25,0
cristin.unitnameInstitutt for psykisk helse
cristin.unitnameInstitutt for sirkulasjon og bildediagnostikk
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode1


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