In clinical research, if it isn't documented, it never happened. Many site owners mistake a competent team for a compliant one—a mistake that leads to disastrous FDA inspections and lost sponsor contracts. In this KLF Deep Dive, Darshan Kulkarni reveals the specific training SOPs, log templates, and contract clauses required to protect your site. Learn how to bridge the gap between "doing the work" and "proving the work" so you can demonstrate a culture of readiness that sponsors trust.
www.kulkarnilawfirm.com
Episode Transcript
So, how do I staff and train my team?
So, sponsors expect your staffto be trained in good clinical
practices, protocol adherence,safety reporting.
If your staff training is notdocumented, inspections can and
have gone very poorly, even ifyour team is competent.
I help create training SOPs andtemplates for logs, so staff
training is fully documented.
I also review contracts withcoordinators, sub-investigators,
(00:22):
and other staff to clarify rolesand liabilities.
Additionally, I provide coachingfor handling protocol deviations
and escalation procedures.
This way, when the FDA orsponsors review your records,
your site demonstrates a cultureof compliance and readiness.
Called, click, or email.
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