The Fundamentals of Clinical Research - P. Michael Dubinsky

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The Data Management Plan 20.11 Quality‐by‐Design Considerations Regarding Clinical Trial Data Collection and Management 20.12 Summary Reference 21 Safety Monitoring and Reporting 21.1 Introduction 21.2 Objectives 21.3 Summary References 22 Monitoring Overview 22.1 Introduction 22.2 Objectives 22.3 Summary Reference 23 Investigator/Institution Selection 23.1 Introduction 23.2 Objectives 23.3 Summary Reference 24 Investigator/Institution Initiation 24.1 Introduction 24.2 Objectives 24.2.4 The Investigator/Institution Initiation Visit 24.2.5 Consequences of Inadequate Investigator(s)/Institution(s) Initiation 24.3 Summary Reference 25 Investigator/Institution Interim Monitoring 25.1 Introduction 25.2 Objectives 25.3 Summary Reference 26 Investigator/Institution Close‐out 26.1 Introduction 26.2 Objectives 26.3 Summary Reference 27 Study Design and Data Analysis 27.1 Introduction 27.2 Objectives 27.3 Clinical Trial Phases and Study Designs in Drug Development 27.4 GCP Considerations for Study Design and Analysis 27.5 Statistical Analysis Plan 27.6 Preparation of Study Data for Analysis 27.7 Analyzing and Reporting Study Data 27.8 Summary References 28 The Clinical Study Report 28.1 Introduction 28.2 Objectives 28.3 Context for a Clinical Study/Trial Report in a Clinical Trial and in Clinical Development 28.4 Summary References 29 Essential Documents 29.1 Introduction 29.2 Objectives 29.3 Summary Reference

      11  Part V: Quality in Clinical Trials 30 Quality Systems in Clinical Research 30.1 Introduction References 31 Quality Responsibilities 31.1 Introduction Reference 32 Standard Operating Procedures 32.1 Introduction 33 Quality Assurance Components 33.1 Introduction 33.2 Objectives 33.3 Audit Plans 33.4 Audit Implementation 33.5 Corrective and Preventive Action – CAPA 33.6 Summary 34 Regulatory Authority Inspections 34.1 Introduction 34.2 Objectives 34.3 Scheduling and Conducting GCP Inspections 34.4 Inspection Readiness – Preparation, Hosting, and Follow‐up 34.5 Summary

      12  References for all Chapters

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