The Fraud and Abuse Control Information System (FACIS™) Level I report includes a search of the sanction information as taken by the Office of Inspector General (OIG), the General Services Administration (GSA) and other federal agencies. This report meets the government’s minimum requirements for sanction screening as set forth in the OIG’s Compliance Program Guidance. This service also includes a search of FDA lists containing the names of clinical investigators who have been disqualified or “totally restricted” by the FDA from conducting studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices. The FDA may disqualify a clinical investigator if that person has repeatedly or deliberately failed to comply with applicable regulatory requirements, or has submitted false information to the sponsor or, if applicable, to the FDA.

