The Fundamentals of Clinical Research - P. Michael Dubinsky

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8.4 Composition, Functions, and Operations 8.5 Procedures 8.6 Records 8.7 Noncompliance by IRB/IECs – Areas of Risk 8.8 Summary References 9 Investigator and Sponsor Roles and Responsibilities 9.1 Introduction 9.2 Objectives 9.3 Summary References 10 The Research Volunteer 10.1 Introduction 10.2 Objectives 10.3 Summary Reference 11 Regulatory Authority – Roles and Responsibilities 11.1 Introduction 11.2 Objectives 11.3 Definition and Overview 11.4 Trial Approval – Submission of Applications 11.5 Communication, Reporting, and Oversight 11.6 Inspections and Oversight 11.7 Summary

      10  Part IV: Individual Clinical Trial 12 Individual Clinical Trial Overview 12.1 Introduction 12.2 Objectives 12.3 Summary Reference 13 Risk Assessment and Quality Management 13.1 Introduction 13.2 Objectives 13.3 Risk Assessment 13.4 Summary Reference 14 Trial Management; Start‐up, On‐Study, and Close‐Out 14.1 Introduction 14.2 Objectives 14.3 Summary Reference 15 Trial Resourcing and Outsourcing 15.1 Introduction 15.2 Objectives 15.3 Summary Reference 16 The Investigator's Brochure 16.1 Introduction 16.2 Objectives 16.3 Summary Reference 17 The Investigational Product (Clinical Supplies) 17.1 Introduction 17.2 Objectives 17.3 Manufacturing and Labeling Requirements 17.4 IP Accountability and Management 17.5 Factors to Consider in the Overall Trial Risk‐Assessment 17.6 Summary References 18 The Clinical Trial Protocol and Amendments 18.1 Introduction 18.2 Objectives 18.3 Summary References 19 Informed Consent and Other Human Subject Protection 19.1 Introduction 19.2 Objectives 19.2.10 Summary of Study Records Related to Human Subject Protection 19.3 Summary Reference 20 Data Collection and Data Management 20.1 Introduction 20.2 Objectives 20.3 GCP Responsibilities for Data Quality 20.4 Data Flow in a Clinical Trial 20.5 Source Data and Source Documents 20.6 Development and Implementation of the Case Report Form (CRF) 20.7 Database Development 20.8 Data Management Processes 20.9 Database Lock 20.10

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