[Answered]: Under ICH E6(R3), which of the following…

Question 4 Under ICH E6(R3), which of the following statements is true regarding shipping an investigational drug directly to a participant’s home and having a home health nurse administer it? geoquad Investigational drugs must always be dispensed at the investigator’s site and cannot be shipped to a participant’s home. geoquad Investigators can ship investigational drugs directly to participants’ homes without additional oversight or documentation. geoquad Home administration of investigational drugs is permitted under ICH E6(R3) but requires documentation of proper shipping, storage, and administration. geoquad FDA regulations mandate that all investigational products (IPs) be administered personally by the investigator at the trial site.