Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 4

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.