Yes. The names and addresses of each of the study sites should be identified in Section
#3. However, if the protocol specifies that the investigative product can be administered
at a subject’s home (for example, the protocol allows for daily injections to be
administered by a registered nurse in the subject’s home), the subjects’ home addresses
do not have to be listed on the 1572. Study records should reflect that the test article was
administered at subjects’ homes per the protocol.
