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What incidences require an IND safety report for drug studies?

  1. Change in trial leadership

  2. Serious and unexpected suspected adverse reactions

  3. Minor side effects

  4. Routine updates of trial progress

The correct answer is: Serious and unexpected suspected adverse reactions

INC safety reports for drug studies are necessary for the reporting of any serious and unexpected suspected adverse reactions. This includes any potentially harmful or life-threatening side effects that were not previously documented or expected during the course of the study. A, C, and D are all incorrect because they do not describe events that would require an IND safety report. A change in trial leadership, minor side effects, and routine updates of trial progress may all be important for the overall management of the study, but they do not require the same level of immediate reporting and monitoring as serious and unexpected adverse reactions.