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Clinical Trial Project Management
- 1st Edition - November 14, 2023
- Author: Ashok Kumar Peepliwal
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 3 6 2 7 - 6
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 3 6 2 8 - 3
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across… Read more
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Request a sales quoteClinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting clinical trials.
- Covers how to conduct clinical trials in detail
- Present useful, basic, and advanced statistical tools
- Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book
Clinical study Coordinators, Clinical Research Associates (CRA), Clinical Team Leaders (CTL), Clinical Project Managers (CPM), and other Clinical Research Professionals, Courses: MBBS, Bachelor of Science, Bachelor of Pharmacy, Bachelor of nursing, Bachelor of biotechnology, Master of science, Master of Pharmacy, Doctoral Program courses, and Community Medicine courses
- Cover image
- Title page
- Table of Contents
- Copyright
- Foreword
- Preface
- Acknowledgments
- Chapter 1. Historical development of clinical research
- Abstract
- 1.1 Development of clinical trials in world
- 1.2 Nuremberg code, Germany, and ethical concerns
- 1.3 Thalidomide disaster
- 1.4 Declaration of Helsinki-1964
- 1.5 Development of clinical trials in India
- References
- Chapter 2. Clinical research
- Abstract
- 2.1 Types of research
- 2.2 Clinical trials
- References
- Chapter 3. Clinical trial approval in world
- Abstract
- 3.1 Clinical trial approval process
- 3.2 Regulatory agencies in world
- 3.3 United States Food and Drugs Administration (requirement)
- 3.4 Europe and its member states
- 3.5 Japan
- 3.6 Brazil (Agência Nacional De Vigilância Sanitária)
- 3.7 India (Central Drugs Standard Control Organization, CDSCO)
- 3.8 Australia
- 3.9 China
- 3.10 Singapore
- 3.11 Canada
- 3.12 Module 1. Administrative and clinical information
- 3.13 Module 2. Common technical document (manufacturing and chemistry)
- 3.14 Module 3. Supporting quality information for clinical study perspective
- References
- Chapter 4. Project management in clinical trials
- Abstract
- 4.1 Project management
- 4.2 Project management in clinical trials
- 4.3 Responsibilities of clinical trial project manager
- 4.4 Clinical trial project management plan
- References
- Chapter 5. Role of stakeholders
- Abstract
- 5.1 Sponsor
- 5.2 Institutional ethics committee (IEC)
- 5.3 Regulatory
- 5.4 Investigator and team as stakeholder
- 5.5 Medical laboratory and team
- 5.6 Contract research organization
- 5.7 Rights of a patient in a clinical study
- References
- Chapter 6. Clinical trial budget assessment and preparation
- Abstract
- 6.1 Clinical trial budget
- 6.2 Pharmaceutical company or sponsor
- 6.3 Contract research organization
- 6.4 Steps in preparation of clinical trial budget
- References
- Chapter 7. Steps to conduct clinical trials
- Abstract
- 7.1 New drugs: dossier submission to regulatory (United States, Europe, India, Australia, etc.)
- 7.2 Generic drugs: submission of dossier for bioavailability-bioequivalence study
- 7.3 Clinical study registration in country-specific registry
- 7.4 Feasibility study and site selection
- 7.5 Ethics committee approval
- 7.6 Clinical study site initiation
- 7.7 Study-specific training
- 7.8 Monitoring of clinical trials
- 7.9 Site close-out visit
- 7.10 Clinical trial database-lock and freezing
- References
- Chapter 8. Clinical data management
- Abstract
- 8.1 Introduction
- 8.2 Clinical data management (CDM)
- 8.3 Roles and responsibilities of clinical data management team
- 8.4 Clinical data management and applicable tools
- 8.5 Standard guidance for clinical data management
- 8.6 Clinical data management (CDM) process
- 8.7 Process flow in clinical data management
- References
- Chapter 9. Audits and inspection
- Abstract
- 9.1 Introduction
- 9.2 Audit
- 9.3 Routine audit
- 9.4 For cause audit
- 9.5 System audit
- 9.6 Audit procedure
- 9.7 Close-out by auditor
- 9.8 Preparation of audit report
- References
- Chapter 10. Serious adverse event reporting and compensation
- Abstract
- 10.1 Introduction to serious adverse event
- 10.2 Reporting of safety information on clinical trials in European Union and its member states
- 10.3 Serious adverse event reporting and compensation procedure in India
- 10.4 Safety reporting procedure
- 10.5 Serious adverse event reporting through SUGAM portal
- 10.6 Capturing data for safe reporting (24 hours, 14 days, and 30 days)
- References
- Chapter 11. Randomization, bias, and blinding
- Abstract
- 11.1 Introduction
- 11.2 Bias in clinical trials
- 11.3 Randomization
- 11.4 Randomization methods
- 11.5 Randomization code generation
- 11.6 Blinding
- References
- Chapter 12. Basic statistical tools for clinical data analysis
- Abstract
- 12.1 Introduction
- 12.2 Basic statistical tools for clinical data analysis
- 12.3 Conclusion
- References
- Chapter 13. Advanced statistical tools for clinical data analysis
- Abstract
- 13.1 Introduction
- 13.2 Crossover design and analysis
- 13.3 Linear regression method
- 13.4 Analysis of covariance
- 13.5 Chi-square test
- References
- Chapter 14. Pharmacovigilance
- Abstract
- 14.1 Introduction
- 14.2 United States of America (USA)
- 14.3 European Union and its Member States
- 14.4 India
- References
- Chapter 15. Clinical study report
- Abstract
- 15.1 Introduction
- 15.2 Procedure to develop clinical study report
- 15.3 Structure and content of clinical study reports
- 15.4 Discussion and overall conclusions
- References
- Chapter 16. Bioavailability and bioequivalence study
- Abstract
- 16.1 Introduction
- 16.2 Requirement of bioavailability/bioequivalence studies
- 16.3 Objectives of bioavailability/bioequivalence (clinical Phase-I) studies
- 16.4 When bioequivalence studies are not necessary (biowaivers)
- 16.5 Study design
- 16.6 Determination of washout period between two periods/two sequences
- 16.7 Subject selection
- 16.8 Fasting or fed conditions
- 16.9 Blood sampling schedule
- 16.10 Procedure of bioavailability/bioequivalence study conductance
- References
- Chapter 17. Risk-based monitoring
- Abstract
- 17.1 Introduction
- 17.2 Risk identification and assessment
- 17.3 Risk formulation
- 17.4 Risk analysis
- 17.5 Risk evaluation
- 17.6 Risk treatment
- 17.7 Risk treatment plan implementation
- References
- Chapter 18. Decentralized clinical trials
- Abstract
- 18.1 Introduction
- 18.2 Differences between decentralized clinical trial and digital trials
- 18.3 Data Integration in decentralized clinicaltrial
- 18.4 Indicators for adoption of decentralized clinicaltrial
- 18.5 Management of decentralized clinicaltrials challenges
- References
- Chapter 19. Electronic clinical outcome assessment and electronic patient-reported outcome
- Abstract
- 19.1 Introduction
- 19.2 Clinical outcome assessment (COA) in new drug development
- 19.3 Electronic patient-reported outcomes
- 19.4 Digital platforms for electronic patient-reported outcome (ePRO) data collection
- References
- Chapter 20. Update of ICH-GCP (addendum R2 and R3)
- Abstract
- 20.1 Introduction
- 20.2 ICH E6 (R2)
- 20.3 Essential documents for the conduct of a clinical trial
- 20.4 ICH-GCP (R3)
- References
- Chapter 21. Frequently asked questions
- Abstract
- Index
- No. of pages: 350
- Language: English
- Edition: 1
- Published: November 14, 2023
- Imprint: Academic Press
- Paperback ISBN: 9780443136276
- eBook ISBN: 9780443136283
AP
Ashok Kumar Peepliwal
Dr. Ashok Kumar Peepliwal holds a PhD in Pharmaceutical Sciences, Bachelor of Pharmacy, LLB, MBA (Human Resource Management). He has extensive experience in conducting clinical trials and project management: including regulatory dossier submission, protocol approvals, site selection, site initiation, site monitoring, and site close-out etc. He has more than 19 years of experience in the pharmaceutical industry (clinical research) and academics as well. Currently he is working as an associate professor at the School of Pharmaceutical Management, IIHMR University
Affiliations and expertise
Associate Professor, School of Pharmaceutical Management, IIHMR University, Jaipur, Rajasthan, India