FDA requires documentation to show that the investigator is
qualified to serve as a study investigator based on their training and
experience specifically related to the proposed clinical investigation.
Such documentation generally includes a curriculum vitae or summary of
training. If this information is already included as part of the CSR,
referencing the appropriate section within the CSR is acceptable. For
research involving novel technologies and/or the potential for increased
risk of morbidity and/or mortality, the sponsor or applicant may wish to
include additional documentation identifying the clinical investigator’s
specific experience in this field (e.g., as demonstrated by recent
presentations or publications) and with the test article.
