Challenge: Research All-Rounder
Question Number 1

Which of the following statements are contained in ICH E6: GCP?

  1. The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
  2. The primary variable (target variable, primary endpoint) should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.
  3. Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.
A
1 only
B
2 and 3 only
C
1 and 3 only
D
None of them

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