治験プロジェクト管理 Clinical Trial Project Management

著者名：Peepliwal, Ashok Kumar

Academic Press（2023/11/15発売）

• 言語：ENG
• ISBN：9780443136276
• eISBN：9780443136283

Description

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 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 etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the 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

Table of Contents

1. History of Clinical Trials2. Clinical Research3. Drug Regulatory and its Obligations4. Project Management in Clinical Trials5. Role of Stakeholders6. Clinical Trial Budget Assessment and Preparation7. Clinical Trials: Steps to Conduct8. Clinical Data Management9. Audits and Inspection10. Serious Adverse Event reporting and Compensation11. Randomization, Bias, and Blinding12. Basic Statistical Tools for Clinical Data Analysis13. Advanced Statistical tools for Clinical Data Analysis14. Pharmacovigilance15. Clinical Study Report16. Bioavailability, Bio-equivalence Study Conductance17. Dos, Don't Dos in clinical trials18. List of CROs19. Question Answers20. References