How will privacy and confidentiality of clinical data, Biology

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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

 


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