Quality Assurance Implementation in Research Labs

✍ Scribed by Akshay Anand (editor)

• Publisher: Springer
• Year: 2021
• Tongue: English
• Leaves: 247
• Category: Library

✦ Synopsis

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, digitization in 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”

✦ Table of Contents

Foreword
Contents
About the Editor
1: Historical Overview of Quality Assurance in Biological Research
1.1 Introduction
1.2 Taylorian Era
1.3 The Era of Quality Control (the 1920s)
1.4 Quality Assurance (1950–1970)/Total Quality Management
1.5 International Organization for Standardization
1.6 Great Failures of Quality
1.7 Good Manufacturing Practices, Good Clinical Practices, and Good Laboratory Practices
1.7.1 Good Manufacturing Practices
1.7.2 Good Clinical Practices
1.7.3 Good Laboratory Practice
1.8 Origin of GLP in India
1.9 Quality Council of India
References
2: Conceptual Framework of Research Data Auditability
2.1 Introduction
2.2 Clinical Research Data Management (CRDM) and Conceptual Framework and QRMS
2.3 Essential Eight Quality Resources for Any Research Organization Are (5M, + 2E, + & 1I)
2.4 Importance of Quality Assurance and Quality Control While Looking at Clinical Research Data
2.4.1 Quality Assurance (QA)
2.4.2 Auditability
2.4.3 Audit Cycle and Quality Improvement
2.5 Framework for Basic Research Auditing
2.6 Designing the Procedures and Policies for Data Auditing
2.6.1 Preparation of a Quality Manual for Research Laboratory
2.6.2 Personnel
2.6.2.1 Study Director
2.6.2.2 Quality Assurance and Document Controller
2.6.2.3 Research Staff
2.6.2.4 Laboratory Technician
2.6.2.5 Laboratory Assistant
2.7 Research Design
2.7.1 Conduct of Research
2.7.2 Planning
2.7.3 Standard Operating Procedure
2.7.4 Data Recording Sheets
2.8 Identification of Problems
2.8.1 Source of Information for Identification of Problems
2.9 Corrective Action
2.9.1 Selection and Implementation of Corrective Actions
2.9.2 Monitoring of Corrective Actions
2.9.3 Additional Audits Where Nonconformities/Departures Cast Doubt
2.10 Capacity Building
2.11 Future Directions and Clinical Implications
References
3: Management of Skilled Human Resources by Youth-Oriented Good Laboratory Practices (YOG)
3.1 Introduction
3.2 Best Practices to Manage Skilled Human Resources
3.2.1 Proactive Habits That Can Increase Productivity of the Youth While Working in the Laboratory
3.2.1.1 Planning the Day in Advance
3.2.1.2 Time Tracking
3.2.1.3 Utilization of Spare Time
3.2.1.4 Understand Productive Hours
3.2.1.5 Clutter-Free Environment
3.2.1.6 Maintain an Inventory Management Software
3.2.1.7 Organize and Update Data
3.2.1.8 Divide Tasks into Smaller Steps
3.2.1.9 Teamwork
3.2.1.10 Cleaning and Maintenance of Equipment
3.3 Communication Among the Team Members for Youth-Oriented GLP (YOG)
3.3.1 Advantages of Good Communication Between Team Members
3.4 Organizational Structure and Its Importance in GLP
3.5 Quality Management System and Its Importance in Development of Skilled Human Resource
3.6 Role of Technology in Skill Development Youth-Oriented GLP (YOG)
3.6.1 Laboratory Information Management System for Maintaining GLP
3.7 Importance of Training and Team Building Workshops in GLP
3.8 Imbibing Work Ethical Behavior in Youth
3.9 Zero Effect-Zero Defect Youth Oriented GLP (ZED-YOG)
3.10 Importance of Skill Development in GLP
3.10.1 Benefits to the Individual
3.10.2 Benefits to the Laboratory
3.11 Suggestions for Training and Skill Upgradation
3.11.1 Suggestions for Individuals
3.11.2 Suggestions for the Laboratory
3.12 Role of Yoga and Meditation to Inculcate Values in the Performance and Dedication to Work
3.13 Future Directions and Clinical Implications
References
4: Operationalization of Research SOPs for PhD Scholars
4.1 Introduction
4.2 SOP and Its Attributes in the Quality Management System
4.3 Lifecycle of an SOP
4.4 Regulatory Requirements
4.5 Regulations of the SOP
4.5.1 FDA Guidelines
4.5.2 Health Canada
4.6 Necessity for a New SOP and the Attributes to Create One
4.7 Types and Content Requirements for a Good SOP
4.8 Sections Governing an SOP
4.9 SOP and Work Instructions: What Is the Difference?
4.10 Approval and Commissioning of SOPs
4.11 Benefits of SOPs
4.12 Implementation of SOPs in PhD or Doctoral Studies
4.13 Importance of Validation
4.14 Future Directions and Clinical Implications
4.15 Conclusion
References
5: Creating Data Recording Sheets (DRS) in Quality Management System
5.1 Introduction
5.2 Creating a DRS
5.2.1 DRS in a Research Laboratory Under GLP
5.2.2 DRS in Food and Drug Administration
5.2.3 DRS in NABL Accredited Laboratories
5.2.4 DRS for Toxicity Test
5.3 Recording Data in DRS
5.4 Electronic Recording of Data and eDRS
5.5 Coding, Indexing, and Location of DRS
5.6 Significance of Record Keeping in Scientific Research
5.7 Future Directions and Clinical Implications
References
6: The Value of Master Schedules in Benchmarking Research Productivity
6.1 Introduction
6.2 Master Schedule
6.2.1 Formative Elements of a Master Schedule and Its Formation
6.2.2 Before Preparing a Master Schedule
6.2.3 Preparing the Master Schedule (Format and Contents)
6.3 Utility of Master Schedule in Research Productivity
6.4 Master Schedule and Research Personnel
6.5 Master Schedule and Study Director
6.6 Master Schedule as a Quality Tool: Recording Deviations in Master Schedule
6.7 Tools and Techniques That Go Handy with Master Schedule
6.8 Technology and Master Scheduling
6.9 Future Direction and Implications
References
7: Logsheets and the Academic Progress of Ph.D. Students
7.1 Introduction
7.2 Laboratory Notebook and Logsheet
7.3 Personal Logsheets
7.3.1 Journal Clubs Attended/Journal Clubs Presented
7.3.2 Seminars Attended/Seminars Presented
7.3.3 Research Meetings Attended
7.3.4 Laboratory Meetings Attended
7.3.5 Research Data Presented
7.3.6 Leave Records
7.3.7 Details of Work Done on Different Projects
7.3.8 Doctoral Committee Meetings
7.3.9 Research Papers Communicated/Published
7.3.10 Conferences Participated
7.3.11 Meetings Held with Visiting/Guest Faculties
7.3.12 Discussion with PI
7.3.13 Community Services
7.4 Laboratory Logsheets
7.4.1 Equipment Maintenance and Operation
7.4.2 Laboratory Environmental Monitoring
7.4.3 Microbiology Media/Reagent
7.4.4 Chemical Inventory
7.4.5 Sample (Test Item) and Reference Items
7.4.6 Coding
7.4.7 Data Collection
7.4.8 Disposal
7.4.9 Change Control of Approved Documents
7.5 Future Directions and Clinical Implications
7.6 Conclusion
References
8: Instigation and Adherence to the Quality Assurance Program to Avoid Academic Conflicts
8.1 Introduction: Quality Assurance in Academics
8.2 Implementation of QA in Academics
8.3 Scientific Misconduct: A Lesson from the History
8.4 Quality Assurance During Formulation of the Research Question
8.5 Quality Assurance in Research Data Generation
8.6 Quality Assurance and Preventing Conflicts During Research Data Presentation
8.7 Intellectual Property and Conflicts
8.8 Role of Quality Assurance Officer in Ensuring Quality and Avoiding Conflicts in Academics
8.8.1 At Experimental and Academic Levels
8.8.2 To Secure the Inception of the Research Idea
8.9 Future Directions and Clinical Implications
8.10 Conclusion
References
9: Data Fraud and Essence of Data Verifiability
9.1 History
9.2 Types of Scientific Misconduct: Falsification, Fabrication, Plagiarism, and Deception
9.3 Types of Manipulation
9.4 Country-Wise Cases of Data Fraud
9.5 Misconduct in Clinical Trials
9.6 Importance of Data Integrity
9.7 How to Identify Research Misconduct?
9.7.1 Software for Data Verifiability
9.7.2 Internal Audits (Preclinical and Clinical Research)
9.7.3 Electronic Health Record (EHR)
9.8 How to Prevent Data Misconduct?
9.8.1 Guidelines and Measures at the Preclinical Level
9.8.1.1 Universal Code of Ethics for Scientists
9.8.1.2 Regulations and Measures to Prevent Data Misconduct
9.8.1.3 Audit of Data Values
9.8.1.4 Good Laboratory Practices for Data Integrity
9.8.1.5 Preclinical Guidelines (OECDs)
9.8.1.6 Checklist for Preclinical Studies for Data Verifiability
9.8.1.7 Journal Policies
9.8.1.8 Publication Ethics
9.8.1.9 Authorship Consent Form
9.8.2 Guidelines and Measures at the Clinical Level
9.8.2.1 Clinical Guidelines: ICH
9.8.2.2 Clinical Trial Registry
9.8.2.3 Checklist for Clinical Studies for Data Verifiability
9.9 Penalty for Data Fraud or Misconduct
9.10 False Allegation of Research Misconduct
9.11 Future Directions and Clinical Implications
9.12 Conclusion
References
10: The Role of Document Control and Archiving Records in Laboratory Management
10.1 Introduction: Document Control and Archiving
10.2 Standard Operating Procedure [4]
10.2.1 Overview
10.2.2 SOP Content
10.2.3 How Should SOPs Be Used?
10.2.4 Designing an SOP
10.3 Purpose of Record Management
10.4 Best Practices for Record-Keeping and Preservation of Historical Records
10.5 Types of Documents and Their Management
10.6 Resources for Document Management
10.7 Requirements for Electronic Data and Paper Data
10.8 The Role of Education and Training in Document Control and Archival of Records
10.9 Common Problems in Document Control and Archiving Records
10.10 Data Recording Sheet (DRS)
10.11 GLP for Maintaining Records and Document Control
10.12 Electronic Records and Its Management
10.12.1 Prerequisites for Electronic Data
10.12.2 Precautions for Storing Electronic Data
10.13 Archival of Records
10.13.1 Access to the Archive
10.13.2 Records to Be Retained
10.13.3 Procedure to Archive
10.13.4 Format of Archiving
10.13.5 Benefits of Proper Archiving
10.14 Electronic Data Archiving
10.14.1 Standard Operating Procedures of Archiving Electronic Records
10.14.2 Benefits of Electronic Archiving
10.15 Future Directions and Clinical Implications
10.16 Conclusion
References
11: Academic Social Responsibility and Quality Assurance in the Developing World: A Framework for Implementation
11.1 Introduction
11.2 Role of United States in Steering Academic Social Responsibility (ASR)
11.3 Global Status of ASR in the Developing World
11.4 ASR in India: More in Policies than in Practice?
11.5 Framework for Implementation of ASR in Indian Academics
11.6 Steps in ASR Implementation
11.7 ASR as Part of a Strategic Planning Process
11.8 Integrating ASR in the Strategic Planning Process
11.8.1 Understand How the Organization Views ASR
11.8.2 Understand Stakeholders’ Strategic Needs and Desires
11.8.3 Determine How ASR Is Vital to the Organization’s Vision and Mission
11.8.4 Recognize and Utilize Quality Management Methods
11.8.5 Commit to Internal Assessment Methods to Know the Effectiveness of Actions
11.8.6 Embrace a Framework or Management System Regarding Tactical Planning for ASR
11.9 Need for Quality Assurance in Implementing ASR
11.10 Future Directions and Clinical Implications
References
12: Good Laboratory Practices: Lab Orientations, Meetings, and Value of Communication
12.1 Introduction
12.2 Lab Orientations
12.3 Different Models of Skill Acquisition
12.4 Communication
12.5 Activities to Improve Communication Skills
12.6 Naming and Categorization of a Communication Medium
12.6.1 Types of Communication
12.6.2 Categorization of Communication
12.6.2.1 PI and Student
12.6.2.2 PI and QA
12.6.2.3 Student and Doctoral Committee
12.6.2.4 Student and Student
12.6.2.5 Junior and Senior Student
12.7 Value of Communication
12.8 Lab Meetings
12.8.1 Meetings Matter-Effects of Team Meetings on Team and Organizational Success
12.8.2 How to Run a Successful Meeting
12.8.3 How to Make the Most Out of a Lab Meeting
12.8.4 Importance of Lab Meetings
12.9 Challenges and Opportunities in Operationalizing Periodic Lab Communication Activities
12.10 Interactions That Help in Training the Students to Practice Their Skills
12.10.1 Formal Presentations
12.10.2 Abstract/Poster Session
12.10.3 Journal Clubs
12.10.4 Progress Update
12.11 Role of Yoga in Better Understanding and Communication
12.12 Future Directions and Clinical Implications
12.13 Conclusion
References
13: Role of Data Digitization on Data Integrity
13.1 Introduction
13.2 Data in a GLP Lab
13.3 Life Cycle of Data
13.4 Principles of Data Integrity
13.5 Need of Digital Transformation
13.6 Efficient Digital Data Management Infrastructure
13.7 Paper to Bits: Conversion of Paper Documents into Digital
13.8 Steps of Digital Transformation
13.9 Digitization Systems/Equipment’s/Components
13.10 Data Security
13.11 Expenses in Digitization Process
13.12 Data Integrity Through Data Auditing
13.13 Digital Data Archive and Data Backup
13.14 Challenges in Data Collection, Digitization, and Maintaining Data Integrity
13.15 Implementation of Data Digitization in a GLP Research Lab to Ensure Data Integrity
13.16 Building the Lab of the Future
13.17 Future Directions and Clinical Implications
13.18 Conclusion
References