GCP - UKM Medical Centre - Universiti Kebangsaan Malaysia
GCP - UKM Medical Centre - Universiti Kebangsaan Malaysia
GCP - UKM Medical Centre - Universiti Kebangsaan Malaysia
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Recent FDA Enforcement Letters<br />
To Clinical Investigators<br />
Most common findings<br />
Failure to follow the protocol<br />
Failure to personally conduct or supervise the<br />
study<br />
Failure to prepare and maintain adequate<br />
and accurate case histories<br />
Failure to maintain drug accountability records<br />
Failure to obtain valid informed consent
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