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What is a key responsibility of an investigator regarding investigational product (IP) in a device trial according to 21 CFR 812?

  1. To store devices until the trial ends

  2. To ensure that the IP is not a device

  3. To administer IP or supervise staff who do

  4. To sell the device post-trial

The correct answer is: To administer IP or supervise staff who do

The key responsibility of an investigator regarding investigational product (IP) in a device trial is to administer the IP or supervise staff who do. This involves making sure that the IP is being properly used and documented, as well as ensuring that all staff involved are properly trained and following the guidelines set forth by the FDA. Options A and D are incorrect because investigators do not store or sell devices in a device trial, but rather use them for the trial under the supervision of the sponsor. Option B is also incorrect, as investigational product in a device trial is, by definition, a device.