5. Investigator and Investigational Product

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

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

10. Roadmap of the submission process of a Clinical Trial

9. Subject considerations

8. Data management

7. Decentralized Clinical Trials

6. Biological specimen

2. General Questions

11. Regulatory Overview - DCT Components

1. Executive Summary