No, the name and address of the research facility is generally not
a sufficient description to meet the requirement in 21 CFR 312.120(b)(2).
Because FDA is generally less likely to be familiar with the research
facilities in which foreign non-IND studies are conducted, greater detail is
usually needed. For example, it would generally be adequate to identify
and briefly describe the academic medical center, hospital, physician’s
office, clinical research unit or other type of facility at which the research
is being conducted. The description should include enough information to
enable FDA to determine the adequacy of the facilities to execute the
protocol requirements (e.g., whether the site is appropriately staffed and
equipped to conduct the proposed research and is able to provide the
appropriate emergent or specialized care, if required).
