Warning Letter: Failure to capture electronic data (ucm399364)

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Ofni Systems

AMKS TRL monitoring failed to identify and correct a clinical investigator’s failure to collect study subjects’ data on protocol-specific case report forms (CRFs), as required by Protocol [redacted]. We note that during the inspection, you indicated that AMKS TRL did not use any paper CRFs or electronic data capture to record study subjects’ data.

View the original warning letter.

 

 


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