Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 3

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.