Question 1:
What are the requirements you need to satisfy for internet usage and remote data capture under 21 CFR parts 11 in a clinical trial?
- Define 21 CFR parts
- Mention requirements for internet usage and remote data capture as per 21 CFR parts
Question 2:
How will Privacy and Confidentiality of Clinical Data (including Subject information) be maintained in a clinical trial?
- Show importance of Privacy and Confidentiality of Clinical Data
- Describe various methods to maintain Privacy and Confidentiality of Clinical Data be maintained in a clinical trial