Warning Letter: Inadequate records (ucm271583)

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Ofni Systems

Failure to maintain adequate drug disposition records raises concerns about subject safety and data integrity. We acknowledge that your written response states that upon your discovery of both the lack of drug accountability and the missing vials, pharmacy and research SOPs were evaluated and revised; and that future studies at your site will be conducted under the umbrella of US Oncology Research, which has an electronic drug accountability system. However, as the clinical investigator, it was your responsibility to ensure that adequate records of the disposition of the drug were maintained; and US Oncology Research’s policies, procedures, and activities do not negate your responsibility as the clinical investigator.

View the original warning letter.


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