Manual Of Biobank Quality Management
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Manual Of Biobank Quality Management
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Author : Agnieszka Matera-Witkiewicz
language : en
Publisher: Springer Nature
Release Date : 2023-02-14
Manual Of Biobank Quality Management written by Agnieszka Matera-Witkiewicz and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-14 with Science categories.
This pioneering handbook serves as an essential tool for any biobanking entity to create, implement and continuously improve their Quality Management System (QMS). Written in a concise and highly readable manner all biobanking related QMS aspects, ranging from legal aspects to safety matters, are addressed according to the best knowledge in compliance with the dedicated Biobanks ISO standards. Following a practical approach by making use of FAQ and common practice sections this book guides the readers through this complex field in an easy-to understand way. The guidelines are convergent not only with ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible, among others with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices. Aimed at both biobank employees and other stakeholders (e.g. public bodies, political bodies, hospitals, pharmaceutical industry, funders) at any level of experience the book serves as valuable source for self-education and teaching. The manual complies to the principles of responsibility, openness, and transparency and can be used by any biobanking unit regardless of the biological material the biobank operates with and independent of their associated biobank network. On behalf of a group of specialists and experts in the area of biobanking, regarding Quality Management Systems (QMS), Ethical, Legal and Societal Issues (ELSI) and IT solutions, the authors present with this book a significant achievement based on activities within the project, European Research Infrastructure BBMRI-ERIC „Quality Standards for Polish Biobanks” Handbook (QSPB).
Biobanking Of Human Biospecimens
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Author : Pierre Hainaut
language : en
Publisher: Springer Nature
Release Date : 2021-08-25
Biobanking Of Human Biospecimens written by Pierre Hainaut and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-25 with Medical categories.
Over the past 25 years, biobanks of human specimens have become a cornerstone for research on human health and have empowered the “omics “revolution that characterizes biomedical science in the XXIst Century. Today, biobanking of human specimens is a critical component of the interface between clinical practice and translational research, supporting the discovery and validation of new biomarkers of disease etiology, risk, early detection, diagnosis, prognosis, prediction and relapse. With the development of personalized medicine, biobanking of cryopreserved specimens has become standard practice in order to investigate genetic, transcriptomic, proteomic, metabolomics and immunological biomarkers useful to inform caregivers for therapeutic decisions. Data generated from biobanked specimens represent a rapidly growing and highly valuable resource, participating in the emergence of Big Data Medicine. With the development of large computing capabilities and artificial intelligence, data associated with biobanked specimens constitute a unique resource for the discovery and validation of new biomarkers and therapeutically actionable targets. Interconnecting, interoperating and sharing this data have become major issues for national health systems, raising enormous stakes as well as major societal, legal and cybersecurity challenges in terms of compliance with the protection of personal sensitive information. This book project is the second part of an initiative launched in 2012 to produce a published corpus of knowledge encompassing all aspects of human biobanking as a central practice for research and medicine. The first volume, published in 2017, is entitled: Human Biobanking: Principles and Practice. This first volume compiled a series of high level contributions overseeing the main developments that carried the progression of human biobanking as a research and biotechnological field over the past two decades. This new book project will constitute de facto Volume 2 of the same initiative, under the title: Biobanking of Human Biospecimens: lessons from 25 years of biobanking experience. Hence, the two volumes will share the same generic title (Biobanking of Human Biospecimens), with different subtitles, making clear that the two volumes are interrelated while highlighting their specificities in terms of what they actually cover. As a result, the two books are “twins” but can also be used independently of each other. The overarching aim of the two volumes of Biobanking of Human Biospecimens is to provide a published “one-stop shop” for state-of-the-art information on what constitutes the field of human biobanking, from conception of a biobank, standard operating procedures, ethical and societal aspects, governance, networking, interoperability and economic sustainability. This inclusive publication concept meets the needs of a vast readership, including scientists, doctors and technical staffs who are directly involved in biobanking operations, scientists in other disciplines that heavily rely on biobanking (such as genomics or proteomics), stakeholders and policy makers, and of course students for whom biobanking is becoming an important part of the training curriculum. So far, there has been a lack of major textbooks on biobanking. Documentation for biobanking is widely available through numerous publications, regulatory documents published by International or Governmental Agencies, and sets of recommendations essentially accessible through the Internet. However, it is difficult to access a single, top-of-the shelf reference that provides at a glance a large coverage of all aspects of human biobanking. Fulfilling this need is the main origin of the concept for this back-to-back publication project. To our knowledge, there is currently no other publication project with the same breath and scope as this one in the field of biobanking.
Population Biobank Studies A Practical Guide
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Author : Zhengming Chen
language : en
Publisher: Springer Nature
Release Date : 2020-12-09
Population Biobank Studies A Practical Guide written by Zhengming Chen and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-09 with Medical categories.
This book describes some of the key epidemiological principles, scientific approaches and quality assurance frameworks required to design and conduct biobank studies in various settings. Using examples from contemporary biobanks, the book addresses the design features and practical procedures needed in order to launch and manage biobank studies, including consent and regulatory approval, the organisation of field work, management of data and biological samples, follow-up and verification of disease outcomes, development of IT systems for data collection, quality assurance and study management. Over the last two decades, several large biobank studies have been initiated in different populations, intended to greatly enhance the development of precision medicine. Contemporary biobank studies are extremely large and complex, and involve several decades of follow-up. Such studies pose major challenges in terms of ensuring rapid recruitment, obtaining high-quality data, minimising loss to follow-up, reliably classifying disease outcomes, and optimising the use of the biological samples collected. In this regard, the key to success lies not in planning the perfect study, but in planning the most appropriate, reliable, sustainable and future-proof study given the practical constraints of available resources, time and capacity. The authors of this handbook are epidemiologists, clinicians, software engineers, and laboratory and data scientists with extensive experience in conducting large biobank studies. The eight chapters can be read separately or together, and provide readers with essential information on how to design, implement and manage these studies. The state-of-the-art, innovative and scalable approaches and methodologies presented here are intended to stimulate the development of further population-based and hospital-based biobank studies in diverse populations.
Advances In Biobanking Practice Through Public And Private Collaborations
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Author : Elena Salvaterra
language : en
Publisher: Bentham Science Publishers
Release Date : 2017-07-10
Advances In Biobanking Practice Through Public And Private Collaborations written by Elena Salvaterra and has been published by Bentham Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-10 with Medical categories.
Advances in Biobanking Practice Through Public and Private Collaborations presents an analysis of methods and current models of partnership between public and private organizations designed to improve biobanking practices in European countries. Chapters describe the state-of-the-art of public-private collaborations in biobanking on a global scale, innovative approaches to public-private partnership the role of a quality management system in biobanking collaborations, quality standard criteria specifically shaped for tumor biobanks, theoretical and practical access conditions to biobanks, the general legal framework governing biobanks at national, European and international levels and a concrete public-private partnership model for managing sample requests. The contributions in this book include examples of established biobanking institutions (such as Spanish National Cancer Research Centre, National Institute of Health, Italy, and 3C-R, France among others) which serve to give readers a concrete perspective on current biobanking practices and relevant legal and ethical issues that shape the field. This book is an ideal handbook for all medical researchers, healthcare professionals and biobanking stakeholders seeking information about international biobanking practices and business models.
Artificial Intelligence And Machine Learning For Digital Pathology
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Author : Andreas Holzinger
language : en
Publisher: Springer Nature
Release Date : 2020-06-24
Artificial Intelligence And Machine Learning For Digital Pathology written by Andreas Holzinger and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-24 with Computers categories.
Data driven Artificial Intelligence (AI) and Machine Learning (ML) in digital pathology, radiology, and dermatology is very promising. In specific cases, for example, Deep Learning (DL), even exceeding human performance. However, in the context of medicine it is important for a human expert to verify the outcome. Consequently, there is a need for transparency and re-traceability of state-of-the-art solutions to make them usable for ethical responsible medical decision support. Moreover, big data is required for training, covering a wide spectrum of a variety of human diseases in different organ systems. These data sets must meet top-quality and regulatory criteria and must be well annotated for ML at patient-, sample-, and image-level. Here biobanks play a central and future role in providing large collections of high-quality, well-annotated samples and data. The main challenges are finding biobanks containing ‘‘fit-for-purpose’’ samples, providing quality related meta-data, gaining access to standardized medical data and annotations, and mass scanning of whole slides including efficient data management solutions.
Handbook Of Quality Assurance In Laboratory Medicine
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Author : Shubangi Tambwekar
language : en
Publisher: Wolters kluwer india Pvt Ltd
Release Date : 2015-01-01
Handbook Of Quality Assurance In Laboratory Medicine written by Shubangi Tambwekar and has been published by Wolters kluwer india Pvt Ltd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-01-01 with Medical categories.
Quality Assurance (QA) is an integral and very important part of laboratory medicine. Pathologists, microbiologists, biochemists and laboratory technicians all need to be proficient in this subject. QA is also mandatory for obtaining accreditation, which ensures a certain level of quality in services being provided. The subject of Quality Assurance (QA), though not new, is a relatively neglected entity and is looked at with some degree of apprehension. This book is addressed to those entrusted with implementing Quality Assurance (QA) in laboratory medicine; generally, these are persons with basic training as pathologists. This handbook is meant as a beginner and handy guide to Quality Assurance; all the basics of Quality Assurance have been incorporated to encourage the beginner to make a start.
Managing The Quality Of Biological Resources
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Author :
language : en
Publisher:
Release Date : 2013
Managing The Quality Of Biological Resources written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
The Laboratory Quality Assurance System
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Author : Thomas A. Ratliff
language : en
Publisher: Van Nostrand Reinhold Company
Release Date : 1990
The Laboratory Quality Assurance System written by Thomas A. Ratliff and has been published by Van Nostrand Reinhold Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990 with Technology & Engineering categories.
The Construction And Development Of Information System Of Clinical Biobank
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Author :
language : en
Publisher:
Release Date : 2017
The Construction And Development Of Information System Of Clinical Biobank written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with categories.
Background: Due to the rapid development of translational medicine research, the construction and application clinical Biobank has got increasing attention. The information system is the core of the Biobank, which plays an important role on sharing of clinical information and specimens. So the development of Clinical Biobank information system should based on supporting the overall process of operation, management and service.Methods: The multifunctional requirements of the clinical Biobank need powerful information system to tracking the full life cycle of biospecimen from collection, receive, transportation, processing, to storage and distribution. So, the function of information system should include management of Biospecimen, Clinical data, Molecular data, materials, personnel, equipment finance, and so on. Biospecimen management system should take sample as center, and Clinical data management take patients as center. Besides common data element standardization is the basic point of information system, which also has characters of flexibility, openness and safety. To construct the information system, the sample/data collection flow should be considered firstly. When the patient entering the hospital through the ADT(Admission, Discharge, Transfer System), doctors recruit them to differentresearch projects according to clinical phenotype and diagnosis , sign informed consent, and begin the sample collecting procedure with CPOE (Computerized Physician Order Entry). With the acquiring of clinical data and diagnosis from AIMS(Anesthesia Information Management System), EMR(Electronic Medical Record), PIS(Pathology Information System), clinical Biobank could access the quality of the biospecimen, then judge whether would bearchive.Results: Compared with the traditional Biobank which rely on manual input data, new generation Biobank are more focused on the quality and integrity of data. The information system joining the sample and data collection process with ADT, CPOE, EMR, LIMS, AIMS, PIS, PACS and MRMS could not only acquire automatically, but also guaranteethe reliability, timeliness and accuracy of the data.Conclusion: A powerful Biobank information system could realize the efficient management and promote comprehensive sharing of biospecimen, Clinical information and Molecular data, which would take advantage of the era of big data to support biomarkers detection, individualized medical treatment, drug research and development.
Biobanks As Essential Tools For Translational Research The Belgian Landscape
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Author : Sofie J. S. Bekaert
language : en
Publisher: Frontiers Media SA
Release Date : 2020-09-17
Biobanks As Essential Tools For Translational Research The Belgian Landscape written by Sofie J. S. Bekaert and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-09-17 with Medical categories.
This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact.