Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example

Haslacher, Helmuth; Bayer, Michaela; Fiegl, Heidi; Gerner, Marlene C.; Hofer, Philipp; Korb, Melanie; Neururer, Sabrina; Perkmann, Thomas; Plattner, Katharina; Sargsyan, Karine; Steiner, Eberhard; Stumptner, Cornelia; Walter, Ingrid; Wieser, Monika; Wutte, Andrea; Wagner, Oswald; Zatloukal, Kurt

doi:10.1515/cclm-2019-0491

Cited by 5 publications

(4 citation statements)

References 7 publications

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“…The assumption of the audit was based on an accessible process called “ friendly audit ”; a similar formula is also presented in BBMRI.de audit system ( 15 ). Also the QM audit process is being noticed in other partner countries from BBMRI-ERIC such as Austria ( 16 ) and Finland. Audits were performed as on-site and remote meetings.…”

Section: Methodsmentioning

confidence: 99%

Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

et al. 2022

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In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of the project was the verification of the current status of QMS in the Polish biobanking institutions and the implementation of common solutions. The main goal was to indicate the current QMS level and determine the starting points for QMS development for each biobank of the Polish Biobanking Network (PBN). Within 3 years, 35 audit visits were performed. The current status and the level of QMS implementation in each biobank were assessed. Five hundred and seventy recommendations were prepared. The data was analyzed using Fischer Exact test to determine whether or not a significant association was observed. Three areas of analysis were covered: (1) BBMRI.pl status, (2) QMS implementation level and (3) private/public party, respectively. The results were discussed within 15 areas. Concluding remarks showed that some differences were observed in the case of subgroups analysis. There is convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between the QMS implementation level in BBMRI.pl Consortium biobanks and PBN biobanks are observed. Nevertheless, the consortium members are obliged to prepare other biobanks willing to enter the PBN as Members/Observers or which already are in the PBN, so that they can meet the requirements of the quality management system that will enable efficient management of biobanking processes in these units. That is why some actions within BBMRI.pl projects are organized to help the whole biobanking community in Poland implement the harmonized solution.

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Section: Methodsmentioning

confidence: 99%

Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

et al. 2022

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“…Примерами наиболее успешно функционирующих как в научном, так и в экономическом аспекте биобанков являются биобанк Университетской клиники г. Грац (Австрия), сохраняющий биологические образцы уже более 30 лет и успешно реализующий научные программы по онкологии на самом высоком уровне [43,44], а также онкологический биобанк Международного агентства Франции по исследованию рака [45].…”

Section: исследования в онкологии с привлечением ресурса биобанковunclassified

Biobanks in oncology: global experience and Russian reality

et al. 2020

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One of the integral components of modern large-scale research projects in the field of medicine are biobanks. The main objective of this infrastructure is the professional collection of biological samples that can be studied with respect to a wide range of molecular biological parameters and will not lose their information value over a long storage period. These samples are made informative not only by correctly conducted preanalytical preparation at the stage of taking samples and placing them in storage, but also by detailed information support (the so-called annotated samples). The sample annotation is the fully collected personal, clinical and laboratory data about a patient. An important point of the biobank infrastructure is compliance with regulatory legal acts and ethical standards, including the procedure for signing an informed consent by a patient about voluntary donation of biological samples and the use of personal data. All this ensures the implementation of the main objective of creating biobanks the wide and uninterrupted availability of collections of biological material for researchers and developers and compliance with specific scientific tasks. This review is devoted to biobanking issues, as well as to the description and analysis of the currently existing oncological biobank infrastructure, both globally and within the Russian Federation.

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“…In biomedical research, irreproducible results are increasingly recognized as a major threat for scientists and the public and causing significant losses of private and public investments in research. Recent investigations have revealed that unreliable results are caused to a large extent by poor biological reagents and reference materials [ 1 – 4 ].…”

Section: Introductionmentioning

confidence: 99%

Pediatric biobanks and parents of disabled children associations opinions on establishing children repositories in developing countries

Gramatiuk¹,

Bagmut

Шеремет

et al. 2021

JMedLife

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Pediatric biobanks are an indispensable resource for the research needed to bring advances in personalized medicine into pediatric medical care. It is unclear how or when these advances in medical care may reach children, but it is unlikely that research in adults will be adequate. We conducted the screening for a hypothetic problem in various European and American pediatric biobanks based on online surveys through e-mail distribution based on the Biobank Economic Modeling Tool (BEMT) questionnaire model. Participants in the survey had work experience in biobanking for at least 3 years or more. Contact information about the survey participants was confirmed on the social networks profiles (LinkedIn), as well as on generally available websites. First, we tried creating a model which can show the pediatric preclinical and basic clinical phase relationship and demonstrate how pediatric biobanking is linked to this process. Furthermore, we tried to look for new trends, and the final goal is to put the acquired knowledge into practice, so medical experts and patients could gain usable benefit from it. We concluded that leading positions must take into account ethical and legal aspects when considering the decision to include children in the biobank collection. However, communication with parents and children is essential. The biobank characteristics influence the biobank's motives to include children in the consent procedure. Moreover, the motives to include children influence how the children are involved in the consent procedure and the extent to which children are able to make voluntary decisions as part of the consent procedure.

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Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example

Cited by 5 publications

References 7 publications

Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

Biobanks in oncology: global experience and Russian reality

Pediatric biobanks and parents of disabled children associations opinions on establishing children repositories in developing countries

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