Falsified Gynecological Examination Reports

February 3, 2008

The NIH Office of Research Integrity has issued a notice on a finding of research misconduct. As usual, Agent writedit is all over it at Medical Writing, Editing & Grantsmanship, category click for prior findings and discussions. So some lower level employee on a clinical trial falsified a couple of records, eh? Big deal right? Is there more to the story?

Going by the Notice, apparently the answer is, no.

Based on the findings of an investigation conducted by Huntington Memorial Hospital (HMH) and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Scott E. Monte, L.V.N., former Clinical Research Associate, HMH, engaged in scientific misconduct by knowingly and intentionally falsifying and fabricating clinical research records in HMH cancer prevention and treatment protocols supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards U10 CA69651, U10 CA12027, U10 CA32012, and U10 CA86004.
Specifically, Mr. Monte knowingly and intentionally: (1) Entered falsified and fabricated laboratory data or physical examination results on five (5) research protocol case report forms (CRFs); (2) Falsified a gynecological examination report in a physician’s progress note and entered the falsified document in the patient’s research chart; and(3) Fabricated progress notes for four patients and a case report form for one of these patients.

Yeah. That’s it. Now you might say, “Well, of course. Falsifying clinical data on a cancer research protocol is a big deal, DM!” And so it is. But one has to have an appreciation for how rare these findings are relative to the number of employees, frequently in low paying positions, who have the opportunity for falsifying a record or six. In the context of hundreds to thousands of data points, well, as the BM and writedit are discussing in the comments, it is astonishing that this guy got caught. Astonishing that it rose to the level of an ORI inquiry.
One backstory here is that this is one of the more common categories of ORI findings of misconduct. Seemingly to my mental boxscore anyway. Some low level chump is caught making up a few data points for some unknown reason. And they seem so…I dunno, picayune. Like there’s a larger story here. As if the big fish managed to slip off the hook leaving the small fry caught. These things just never seem to add up to me.

2 Responses to “Falsified Gynecological Examination Reports”

  1. suesquatch Says:

    A nurse getting nailed for something the higher-ups had them document? Say it isn’t so.


  2. I’ve been in the clinical research business for a decade and reading this, a more likely possibility occurs to me. Unfortunately, physicians do not chart in complete sentences or even complete words. And they often will not chart normal observations, only abnormal observations. But when you are entering data into a case report form, absence of evidence does not equal evidence of absence. I’ll give a hypothetical.
    I am monitoring the case report form. I am comparing the data in the CRF with the patient’s chart. I see that 9 of the 10 physical examination observations are entered in the CRF as “normal” but the physician charted only point 10 as “abnormal”. I point this out to the study coordinator as being in error because the chart does not match the CRF; the chart has only one data point but the CRF has ten. So the coordinator goes back into the chart to add that the other nine data points were normal. HE knows that no notation by that physician equals normal, but I don’t and an auditor wouldn’t know that (or care) either.
    I’m not saying this fellow is completely innocent, I’m just saying that sometimes these things don’t necessarily happen because a study coordinator thought to himself one day: you know what? I think I’ll just make this up. Especially at research sites where one coordinator is doing data entry for a dozen different trials at the same time, which is often the case at sites I monitor.


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