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 812.43(c)]Failure to obtain a signed agreement from<br />
each participating investigator, which must contain a<br />
commitment from the investigator to promptly update the<br />
financial disclosure information if any relevant changes occur<br />
during the course of investigation <strong>and</strong> for one year following<br />
the completion of the study.<br />
•Response: SOPs instituted to monitor investigator financial<br />
involvement<br />
•<strong>FDA</strong> Response: Provided SOPs inadequate; do not include<br />
provision of monitoring, whereby investigators are required to<br />
provide a financial interest update following changes in their<br />
financial interests in the company for one year following the<br />
completion of the study.
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