The Study Start-Up Module

Once you set up the basic configurations and contacts for Study Start-Up, you can now move forwardto operate the module. The Study Start-Up Module comprises the following topics.

1. Accessing the Study Start-Up Module
2. The SSU User Interface
3. Sites
4. Countries
5. IRB/EC
6. Regulatory Review
7. Collecting Required and Non-Required Documents
8. Documents
9. Regulatory Review
10. Communication Log
11. Contacts
12. Steps to Site Activation
13. Amendments
14. Overview Dashboard
15. Reports

Each of these topics with their subtopics is described in detail in the subsequent sections.