Hormone replacement study

Reference no: EM133626292

Question

A 50-year-old woman is a subject in a hormone replacement study. During her participation in the study she develops strep throat and is prescribed an antibiotic by her primary care physician. Three days after beginning the antibiotic she experiences a respiratory arrest. The EMTs take her to the local hospital where she remains in the intensive care unit on life support. The investigator learns of this series of events one day after the subject was admitted to the hospital. He is not sure what caused the event, although, he believes there is a reasonable possibility that a relationship between the study drug and the event exists. The Investigator's Brochure does not reference respiratory arrest or strep throat as known, observed effects. In the scenario above, once the sponsor learns of these events what should the sponsor do with the information?

Reference no: EM133626292

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