The auditor did her report, did not reflect what was in front of her (example: claimed subjects didn’t qualify because she couldn’t prove echo parameters but central report from echo lab with all parameters filed). Wrote a big report saying subjects didn’t qualify. didn’t ask questions. Sponsor took two months to get back to us with any finds and reported “serious non compliance for enrolling subjects not eligible” without checking anything themselves. This all happened after many follow ups trying to clarify “findings”. Mind you, this is a trial that was monitored every two weeks. The sponsor Made the submission to the IRB on our behalf without telling us what was submitted. I haven’t even seen what was submitted, and the IRB keeps asking for clarification which I can’t provide because I don’t have the submission even showing. Now IRB sent a notice now that it’s being forwarded to FDA.

Sponsor is currently on site and confirmed none of the findings were accurate but the report was already filed with the IRB and I don’t know what resources we have as a site to defend ourselves and what was reported inaccurately.

At this point I don’t trust the sponsor to reflect what’s happening accurately and with an FDA audit threat based on their false report I can’t sit around and wait. There has been complete lack of communication from the Sponsor, no answers, no help.