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This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitizationin data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally.
From the foreword by Ratan Tata, India This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology
Covers all aspects of historical and conceptual framework of quality assurance with step by step notes on implementation Provides all aspects of quality assurance with personalized experimental examples Presents easy to follow algorithms and key points in each chapter
Auteur
Akshay Anand works as a Professor at Neuroscience Research Lab, Department of Neurology, and Prof in Charge, CCRYN Collaborative Center for Mind Body INterventions by Yoga, PGIMER, Chandigarh. He is an Adjunct Professor, Centre for Phenomenology and Cognitive Sciences, Department of Philosophy, Punjab University, Chandigarh and an Editor in Chief of Annals of Neurosciences and Integrative Medicine Case Reports (JIMCR) and a former EIC of Integrative Medicine International. He has 203 publications in International peer reviewed Journals (including 30 Policy research commentaries) besides filing four patent applications. He has mentored 14 PhD students and completed 20 research grants and remains profusely funded by various national funding agencies, advising various editorial, policy and scientific enterprises across 30 countries. His research interests range from understanding of neuronal cell survival mechanisms using in vitro, in vivo, genetic, and alternative approaches (mindfulness techniques) to discovering biomarkers of Neuro degenerative disorders for clinical applications. His research lab is the only research lab in India to voluntarily operationalize a voluntary Quality Assurance regimen duly recognized by the Quality Council of India. He serves as a Visiting Professor of the Kyoto University of Medicine and S-VYASA, Bengaluru and earlier also served with Lesya Ukrainian Eastern European National University, Lutsk and Sri Sri Institute of Advanced Research, Bengaluru as its Visiting Professor/Visiting Scientist. Dr Anand was nominated for India's prestigious Padma Award, 2020 besides being honored by UT Police for exemplary work in advancement of Yoga research. He has been awarded for ICMR Amrut Mody Unichem Prize-2012, Annual PGI faculty award-2013, 2014, Sardar Vallabhbhai Patel Foundation 9th International Prestigious Sardar Patel Award, 2014, Scopus Young Scientist Award Runner up, National Academy of Sciences India, New Delhi, 2012, ICMR Shakuntala Amir Chand Award (2010), Young Scientist Award from DAE (2005), Retina Research Foundation/Joseph M. and Eula C. Lawrence Award (2003). He is also an Advisory Board Member, Harvard University, Boston, USA and an advisor of Research Activities in Sivananda Yoga Vedanta Academy, Bhubaneswar. He also a Member of Academic and Administrative Committee, Center of Phenomenology and Cognitive Sciences-2021. His academic social activities like PM's Clean India program and "yoga scholars PGIMER" have cultivated an increased sense of preventive healthcare among his students, colleagues, and science practitioners.
Contenu
1 Historical Overview of Quality Assurance in Biological Research.- 2 Conceptual framework of research data auditability.- 3 Management of skilled human resources by Youth Oriented Good Laboratory Practices (YOG).- 4 Operationalization of research SOPs for PhD scholars.- 5 Creating Data Recording Sheets (DRS) in quality management system.- 6 The value of Master Schedules in benchmarking research productivity.- 7 Logsheets and the Academic Progress of PhD Students.- 8 Instigation and adherence to the quality assurance program to avoid academic conflicts.- 9 Data fraud and essence of data verifiability.- 10 The role of document control and archiving records in laboratory management.- 11 Academic Social Responsibility and Quality Assurance in the developing world a framework for implementation.- 12 Good Laboratory Practices: Lab orientations, meetings and value of communication.- 13 Role of data digitization on data integrity.