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Well, the company I was with at the time had (and still has) some *very* high-profile problems, but none that I know of stemmed from consent forms. As far as the consent forms I personally authored, it will be many years before the drug trial results and documentation will go to the FDA for review, so all I can do is hope I did my best for the company *and* the patients.
--- Felice Albala <felice_albala -at- yahoo -dot- com> wrote:
The docs could have no more than a 6th grade Flesch-Kincaid score...The purpose was to make sure participants understood as best they could all the details of the clinical trial, and of course, to protect the Company against lawsuits.
Did that work out during the time you were there?
Milan
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