{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,18]],"date-time":"2026-01-18T05:00:12Z","timestamp":1768712412932,"version":"3.49.0"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T00:00:00Z","timestamp":1572307200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T00:00:00Z","timestamp":1572307200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n              <jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-019-3702-z","type":"journal-article","created":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T20:44:07Z","timestamp":1572468247000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["European survey on national training activities in clinical research"],"prefix":"10.1186","volume":"20","author":[{"given":"A.","family":"Magnin","sequence":"first","affiliation":[]},{"given":"V. Cabral","family":"Iversen","sequence":"additional","affiliation":[]},{"given":"G.","family":"Calvo","sequence":"additional","affiliation":[]},{"given":"B.","family":"\u010ce\u010detkov\u00e1","sequence":"additional","affiliation":[]},{"given":"O.","family":"Dale","sequence":"additional","affiliation":[]},{"given":"R.","family":"Demlova","sequence":"additional","affiliation":[]},{"given":"Gy.","family":"Blasko","sequence":"additional","affiliation":[]},{"given":"F.","family":"Keane","sequence":"additional","affiliation":[]},{"given":"G. L.","family":"Kovacs","sequence":"additional","affiliation":[]},{"given":"C.","family":"Levy-Marchal","sequence":"additional","affiliation":[]},{"given":"E. C.","family":"Monteiro","sequence":"additional","affiliation":[]},{"given":"L.","family":"Palmisano","sequence":"additional","affiliation":[]},{"given":"D.","family":"Pella","sequence":"additional","affiliation":[]},{"given":"A.","family":"Portol\u00e9s P\u00e9rez","sequence":"additional","affiliation":[]},{"given":"O.","family":"Rascol","sequence":"additional","affiliation":[]},{"given":"C.","family":"Schmid","sequence":"additional","affiliation":[]},{"given":"F.","family":"Tay","sequence":"additional","affiliation":[]},{"given":"H.","family":"von der Leyen","sequence":"additional","affiliation":[]},{"given":"C.","family":"Ohmann","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2019,10,29]]},"reference":[{"key":"3702_CR1","doi-asserted-by":"publisher","first-page":"179","DOI":"10.4103\/picr.PICR_106_18.","volume":"9","author":"M Konwar","year":"2018","unstructured":"Konwar M, Bose D, Gogtay NJ, Thatte UM. Investigator-initiated studies: Challenges and solutions. Perspect Clin Res. 2018;9:179\u201383. \n                    https:\/\/doi.org\/10.4103\/picr.PICR_106_18.","journal-title":"Perspect Clin Res"},{"key":"3702_CR2","doi-asserted-by":"publisher","unstructured":"Madeira C, Santos F, Kubiak C, Demotes J, Monteiro EC. Transparency and accuracy in funding investigator-initiated clinical trials: a systematic search in clinical trials databases. BMJ Open. 2019. \n                    https:\/\/doi.org\/10.1136\/bmjopen-2018-02339\n                    \n                  .","DOI":"10.1136\/bmjopen-2018-02339"},{"key":"3702_CR3","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1016\/j.conctc.2016.08.002.","volume":"4","author":"C Madeira","year":"2016","unstructured":"Madeira C, Pais A, Kubiak C, Demotes J, Monteiro EC. Investigator-initiated clinical trials conducted by the Portuguese Clinical Research Infrastructure Network (PtCRIN). 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Portugal clinical scholars research training. 2019. \n                    https:\/\/postgraduateeducation.hms.harvard.edu\/certificate-programs\/custom-programs\/portugal-clinical-scholars-research-training\n                    \n                  . Accessed 23 Apr 2019."},{"key":"3702_CR18","unstructured":"National University of Ireland Galway. MSc (Clinical Reserach) \u2013 Full-Time or Part-Time. 2018. \n                    http:\/\/www.nuigalway.ie\/taught-postgraduate-courses\/clinical-research.html\n                    \n                  . Accessed 15 Sep 2018."},{"key":"3702_CR19","unstructured":"University College Dublin School of Medicine. MSc Clinical & Translational Research - Full Time. 2012. \n                    http:\/\/www.ucd.ie\/medicine\/studywithus\/graduatestudies\/clinicalresearch\/mscclinicaltranslationalresearch-fulltime\/\n                    \n                  . 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Training Opportunities. 2019. \n                    https:\/\/www.scto.ch\/en\/education-and-careers\/training.html\n                    \n                  . Accessed 26.030.2019."},{"key":"3702_CR24","unstructured":"Universidade Nova De Lisboa. Nova Medical School. Master in Clinical Research Management - MEGIC. \n                    http:\/\/www.nms.unl.pt\/main\/index.php?option=com_content&view=article&id=2346:master-in-clinical-research-management-megic&catid=2:uncategorised&Itemid=482&lang=pt\n                    \n                  . Accessed 15 Mar 2019."},{"key":"3702_CR25","unstructured":"Universit\u00e4t Leipzig Medizinische Fakult\u00e4t. M.Sc. Clinical Research & Translational Medicine. \n                    https:\/\/www.zks.uni-leipzig.de\/Masterstudium-Clinical-Research\n                    \n                  . Accessed 15 Mar 2019."},{"key":"3702_CR26","unstructured":"Universit\u00e4t Duisburg-Essen Akademisches Beratungszentrum. Pharmaceutical Medicine (M.Sc.). 2019. \n                    https:\/\/www.uni-due.de\/studienangebote\/studiengang.php?id=82\n                    \n                  . Accessed 15 Mar 2019."},{"key":"3702_CR27","unstructured":"Universit\u00e4tsklinikum Heidelberg Medizinische Biometrie und Informatik. Msc Medical Biometry. 2019. \n                    https:\/\/www.klinikum.uni-heidelberg.de\/Profil.100261.0.html\n                    \n                  . Accessed 26 Mar 2019."},{"key":"3702_CR28","unstructured":"Dresden International University. Clinical Research (MSc). 2019. \n                    https:\/\/www.di-uni.de\/studium-weiterbildung\/medizin\/clinical-research\n                    \n                  . Accessed 15 Mar 2019."},{"key":"3702_CR29","unstructured":"Centrial Kooperationspartner des Universti\u00e4tsklinikum T\u00fcbingen. 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