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In the context of the Pediatric Clinical Research Infrastructure Network (PedCRIN) project, an easy\u2010to\u2010use tool has been developed to guide investigators and sponsors in managing specimens and associated data in compliance with the applicable European rules in the context of pediatric clinical trials. Key topics and research questions to properly manage biosamples and related data in the context of pediatric trials were identified by PedCRIN partners; the current European regulatory\/ethical and legal resources were searched for and analyzed; the items\/measures\/procedures to ensure regulatory compliance of a pediatric trial with regards to biosamples were defined. A checklist of the key items to be considered for the management of biological samples in pediatric clinical trials in compliance with the European applicable rules and legislation, was prepared. It is publicly available on the PedCRIN website <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/ecrin.org\/projects\/pedcrin\">https:\/\/ecrin.org\/projects\/pedcrin<\/jats:ext-link>. Five different topics were covered: consent and assent; minimizing harm and maximizing welfare; sampling volume; skills, training and facilities required for sampling; and long\u2010term storage of biological material. This exercise addressed a specific need in the field of pediatric research to implement ad hoc procedures for specimen handling. In fact, specific guidance on the management of biosamples in pediatrics is not available.<\/jats:p>","DOI":"10.1111\/cts.13489","type":"journal-article","created":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T11:29:35Z","timestamp":1675942175000},"page":"797-809","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["<scp>PedCRIN<\/scp> tool for the biosamples management in pediatric clinical trials"],"prefix":"10.1111","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2534-6783","authenticated-orcid":false,"given":"Viviana","family":"Giannuzzi","sequence":"first","affiliation":[{"name":"Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus  Valenzano Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9820-3890","authenticated-orcid":false,"given":"Lucia","family":"Ruggieri","sequence":"additional","affiliation":[{"name":"Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus  Valenzano Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2049-8929","authenticated-orcid":false,"given":"Rosa","family":"Conte","sequence":"additional","affiliation":[{"name":"Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus  Valenzano Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3755-0474","authenticated-orcid":false,"given":"Cristina","family":"Manfredi","sequence":"additional","affiliation":[{"name":"Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)  Pavia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7315-0857","authenticated-orcid":false,"given":"Mariagrazia","family":"Felisi","sequence":"additional","affiliation":[{"name":"Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)  Pavia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1505-8622","authenticated-orcid":false,"given":"Christine","family":"Kubiak","sequence":"additional","affiliation":[{"name":"The European Clinical Research Infrastructure Network (ECRIN)  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mihaela","family":"Matei","sequence":"additional","affiliation":[{"name":"The European Clinical Research Infrastructure Network (ECRIN)  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salma","family":"Malik","sequence":"additional","affiliation":[{"name":"The European Clinical Research Infrastructure Network (ECRIN)  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-0746","authenticated-orcid":false,"given":"Jacques","family":"Demotes","sequence":"additional","affiliation":[{"name":"The European Clinical Research Infrastructure Network (ECRIN)  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8778-3612","authenticated-orcid":false,"given":"Adriana","family":"Ceci","sequence":"additional","affiliation":[{"name":"Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus  Valenzano Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2636-9159","authenticated-orcid":false,"given":"Donato","family":"Bonifazi","sequence":"additional","affiliation":[{"name":"Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)  Bari Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,2,19]]},"reference":[{"key":"e_1_2_10_2_1","first-page":"695","article-title":"Pharmacokinetic studies in children: recommendations for practice and research","volume":"103","author":"Barker CIS","year":"2018","journal-title":"Arch Dis Child"},{"key":"e_1_2_10_3_1","unstructured":"DIRECTIVE 2004\/23\/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation procurement testing processing preservation storage and distribution of human tissues and cells."},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.4172\/2157-7552.1000116"},{"key":"e_1_2_10_5_1","unstructured":"Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples 2010 EMA\/INS\/GCP\/532137\/2010 GCP Inspectors Working Group."},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.56759\/rgxl7405"},{"key":"e_1_2_10_7_1","unstructured":"Committee for Medicinal Products for Human Use (CHMP).Role of pharmacokinetics in the development of medicinal products in the paediatric population;2006. 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