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

Peepliwal, Ashok Kumar

Academic Press Inc（2023/11発売）

• 製本 Paperback:紙装版/ペーパーバック版／ページ数 350 p.
• 言語 ENG
• 商品コード 9780443136276
• DDC分類 610.724

Full 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. 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.

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