In this episode, Darshan Kulkarni dives into the terrifying reality of compliance failures at clinical trial sites. While most directors worry about standard fines, the true danger lies in the "off-the-book" penalties and the looming threat of criminal prosecution for employing excluded physicians. If you aren't auditing your lists correctly, you aren't just risking a citation—you're risking your entire career.
www.kulkarnilawfirm.com
Episode Transcript
If you are a clinical trial site, you must
have a process of checking theselists to ensure that you are not
employing or retaining orcontracting with physicians who
are on any of these lists.
Then there are civil penaltiesand criminal prosecution, all of
which needs to be considered.
SPEAKER_01 (00:21):
It's also important to recognize that there are some
other alternatives, otherpenalties that may be imposed
that are not strictly by thebook.
And what I mean by that is
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