Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News
Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News
Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News
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Sponsor Warning Letters<br />
•[21 CFR 312.50]failure to ensure proper monitoring of the<br />
investigation . Overdosing of six subjects at Dr A’s site was<br />
neither recognized nor reported by study monitors in a timely<br />
manner. Ultimately identified by Data Management query five<br />
months after overdosing occurred.<br />
•Response: SOP will be put into place to ensure compliance<br />
with the <strong>FDA</strong> regulations in the future.<br />
•<strong>FDA</strong> Response: We acknowledge your firm’s assurance that<br />
corrective actions will be taken. However, we note that the<br />
response did not contain a detailed outline of procedures or<br />
processes, as well as CRA <strong>and</strong> site staff training, that would be<br />
implemented to prevent the future occurrence of these<br />
observations.
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