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Link rowid title DOI URL created subject references-count is-referenced-by-count ISSN container-title ▼ abstract author_number orcids names award_numbers funder_names funder_dois
52 ["DEVELOPMENT AND ESTABLISHMENT OF A QUALITY-FRAMEWORK FOR THE LENA PROJECT"] 10.1136/archdischild-2015-310148.72 http://dx.doi.org/10.1136/archdischild-2015-310148.72 2015-12-15T08:07:33Z ["Pediatrics, Perinatology, and Child Health"] 0 0 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Background</jats:title><jats:p>The LENA (Labeling of Enalapril from Neonates up to Adolescents) project has been initiated to improve the healthcare of children with heart failure by an enalapril orodispersible mini-tablet. The LENA consortium combines academic clinical research centers, SMEs (small and medium-sized enterprises) and a patient/parent advocacy organization. The objective of the project requires to comply with respective GxP regulations like Good Manufacturing Practice (GMP), Good Clinical (Laboratory) Practice (GCP/“GCLP”1) and Good Vigilance Practice (GVP). The project team is comprised of sub-teams experienced in paediatric clinical practice, medicines development, clinical research and project management, but not all team members work in an appropriate quality framework. Aim: To establish a well-documented, efficient quality system applying a new approach for ensuring quality in all trial aspects by combining existing organization-related quality system elements of the project partners with newly developed SOPs and overarching, integrating trial-specific elements to ensure a reliable quality environment for the LENA Phase I clinical trial.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Based on the network-structure of the project organization, a strategy based on a team approach with joint responsibilities for the quality conduct of the project was pursuit, forming a QM Team consisting of the project leader, the leaders for pharmaceutical and clinical development and an external quality expert. The team compiled a quality manual and an organizational chart displaying the sub-teams and their responsibilities. Another responsibility of the team is the integration of existing SOPs and Work Instructions as well as the creation of procedures at the project level and furthermore the verification of appropriate qualification of all staff involved in the project through CVs, job descriptions and training records.</jats:p></jats:sec><jats:sec><jats:title>Resul… 7 [] ["Agnes M. Ciplea", "Karl Kleine", "Bj\u00f6rn B. Burckhardt", "Stephanie L\u00e4er", "J\u00f6rg Breitkreutz", "Lucie \u0160patenkov\u00e1", "Ingrid Klingmann"] [""] [""] [""]

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   [title] TEXT,
   [DOI] TEXT,
   [URL] TEXT,
   [created] TEXT,
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   [references-count] TEXT,
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