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25 August, 13:39

An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following?

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  1. 25 August, 15:37
    An investigator's Agreement or Commitment


    Notice of the dedication of the investigator to:

    perform the investigation in compliance with the agreement, the investigation plan, the IDE and other relevant FDA regulations, and the conditions of approval imposed by the IRB or FDA inspection, supervise all testing of the product involving human subjects.
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