Challenge: ICH GCP Test
Question Number 1
Which of the following is the ICH GCP definition of Essential Documents?
A
Documents to provide evidence of compliance to the applicable guidelines and local regulatory requirements.
B
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of data produced.
C
The minimum documentation required to legally allow subjects to be recruited into a study.
D
Documents to demonstrate compliance with the protocol, the relevant guidelines and applicable local regulatory requirements.

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