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Medtronic plc Message Board

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  • ma45342312 ma45342312 Jul 1, 2011 12:14 PM Flag

    Ty Webb/Mitch Cumstien


    It just dawned on me what you meant in your last post. "therefore I do not have to fill out an adverse event form"

    For you and other readers I apologize for making a poor assumption The assumption was that you understood the basics of clinical trial research. The physician in the hypothetical scenario that I spoke of earlier does not have the right to make the call "therefore I do not have to fill out an adverse event form" If an infection occurred during a clinical trial the investigator or commonly know as the physician has an obligation to report an infection that occurred as a result of a surgery when an investigational product was used that adverse event form then goes to an adjudication committee which is a team of experts and they decide if the infection is the result of the investigational product.

    This is how investigational medical device trials work. The physician or investigator that was unduly influenced by the fact that he is getting paid millions by the sponsor is considered severly biased in the clinical trial world. So therefore his research is suspected to be biased and not of sound clinical science.

    I should have explained that in the post of the hypothetical patient. An adverse event form definitely should have been filled out in that scenario.

    Sorry for the poor assumption I made

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