10. Roadmap of the Submission Process of a Clinical Trial

5. Investigator and Investigational Product

9. Subject Considerations

7. Decentralized Clinical Trials

4. Regulatory Authority (RA)/ Competent Authority (CA)

3. Ethics Committee (EC)/ Institutional Review Board (IRB)

8. Data Management

6. Biological Specimen

2. General Questions

1. Executive Summary

11. Regulatory Overview - DCT Components