The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort.
This advance understanding does not authorize BARDA to share financial information outside HHS.
BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trial of licensed products; and clinical research of any type involving more than minimal risk to volunteers.
They must also provide BARDA initial and annual documentation of continuing review and approval and federal wide assurance number.
BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary.