Challenge: ICH GCP Committees
Question Number 1

According to ICH GCP the sponsor may consider establishing an independent data-monitoring committee to assess the progress of a trial. This includes safety data and critical efficacy endpoints. What is the purpose of the IDMC?
A
To ensure the trial will deliver a positive outcome
B
To recommend to the sponsor whether to continue, modify or stop a trial
C
To ensure that the protocol is being adhered to
D
To recommend changes to the protocol to ensure the safety of patients

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