The EMA has added a new Q&A (#13) regarding requirements for Principal Investigator (PI) review and sign-off of data.
The investigators are responsible for data entered into eCRFs and other data collection tools under their supervision (electronic records). Those data should be reviewed and signed-off.
It is important that the PI reviews the data on an ongoing basis in order to detect shortcomings and deficiencies in the trial conduct at an early stage, which is the precondition to undertake appropriate corrective and preventive actions.
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