Sponsors and other regulated entities are responsible for meeting the regulatory
requirements. Moreover, sponsors are responsible for assessing the authenticity and
reliability of any data used to support a marketing application for a medical product.
Thus, the sponsor is ultimately responsible for the clinical investigation and for ensuring
that all records and data required to adequately perform and document the clinical
investigation are obtained and available to FDA upon request and in a timely and
reasonable manner (21 CFR 312.57, 312.58, 312.62, 312.68, 812.140, and 812.145).
