In most cases, a brief summary of the IEC actions to approve or
modify and approve the clinical investigation would be sufficient. For
example, it may suffice to provide FDA with the name of the IEC and a
list of IEC actions and dates (e.g., initial approval date, date of approval of
modification, etc.), or alternatively to provide FDA with the approval
letters from the IEC (including those for protocol amendments). If FDA
determines that additional information is necessary to understand the
IEC’s decisions on the clinical investigation, the Agency will request this
information from the sponsor or applicant.
