Challenge: ICH GCP Data Handling and Management
Question Number 1

According to ICH GCP when using electronic trial data handling and/or remote electronic trial data systems, the sponsor should ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data. This means keeping which of the following trails

  1. audit trail
  2. data trail
  3. edit trail
A
1 only
B
1 and 2 only
C
1 and 3 only
D
All of them

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