Clinical Trial Impartial Witness

A Clinical Trial Impartial Witness is a person who is independent of and cannot influence a clinical trial, but who can read an informed consent form or any other written information supplied to a clinical trial participant.

• Example(s):
  • …
• Counter-Example(s):
  • Historical Control Subject,
  • Healthy Control,
  • Cohort Group,
  • Placebo Group,
  • Treatment Group.
• See: Retrospective Cohort Study, Placebo-Controlled Clinical Trial, Crossover Clinical Trial, Parallel Clinical Trial, Multi-Arm Clinical Trial, Dynamic Clinical Trial.

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References

2022

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-02-06.
  • A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. (ICH E6)

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