Full Description
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"
Contents
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.
