The Fundamentals of Clinical Research. P. Michael Dubinsky

      14  End User License Agreement

      List of Tables

      1 Chapter 13Table 13.1 Documentation of information gathered during risk identification.

      2 Chapter 14Table 14.1 Functions of the sponsor.Table 14.2 Functions of the investigator.

      3 Chapter 18Table 18.1 Example of phase 2 study objectives, endpoints, and study assessm...

      4 Chapter 19Table 19.1 Descriptions of minimum elements for adequate informed consent of...Table 19.2 Essential documents pertaining to the protection of the rights, s...

      5 Chapter 22Table 22.1 GCP principle and associated trial monitoring application.

      6 Chapter 23Table 23.1 Investigator/institution selection checklist.

      7 Chapter 24Table 24.1 Investigator/institution iniiation checklist.

      8 Chapter 25Table 25.1 Investigator/institution interim monitoring checklist.

      9 Chapter 26Table 26.1 Investigator/institution closeout checklist.

      10 Chapter 31Table 31.1 Overview of expectations which fall to the sponsor.

      11 Chapter 32Table 32.1 Expectations for written procedures (constructed from ICH E6(R2)...Table 32.2 The most common issues arising from SOPs.

      List of Illustrations

      1 Chapter 2Figure 2.1 The clinical trial regulatory matrix.

      2 Chapter 7Figure 7.1 Players interaction.

      3 Chapter 11Figure 11.1 Regulatory Authority’s interaction with other players.

      4 Chapter 12Figure 12.1 Milestones for a clinical trial.

      5 Chapter 14Figure 14.1 Example of items tracked in a clinical trial management system f...Figure 14.2 Examples of other operational items tracked for a specific trial...Figure 14.3 Example of table of contents for trial operations plan.Figure 14.4 Milestones for a clinical trial.

      6 Chapter 22Figure 22.1 Extent and nature of monitoring based on trial characteristics....Figure 22.2 GCP principle and associated trial monitoring application.

      7 Chapter 23Figure 23.1 Investigator/institution responsibilities to review for selectio...Figure 23.2 Process for investigator selection.

      8 Chapter 24Figure 24.1 Investigator/institution responsibilities to review for initiati...

      9 Chapter 25Figure 25.1 Investigator/institution responsibilities to review for interim ...

      10 Chapter 26Figure 26.1 Investigator/institution responsibilities to review for closeout...

      11 Chapter 30Figure 30.1 A quality management system.

      12 Chapter 33Figure 33.1 CAPA system inputs.

      Guide

      1  Cover Page

      2  The Fundamentals of Clinical Research

      3  Copyright

      4  Preface

      5  About the Authors

      6  About the Authors

      7  Table of Contents

      8  Begin Reading

      9  References for all Chapters

      10  Index

      11  The Fundamentals of Clinical Research

      12  WILEY END USER LICENSE AGREEMENT

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