Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute

Zusammenfassung

The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the National Cancer Institute (NCI) and the Food and Drug Administration (FDA) (collectively "the Parties", or individually as a "Party") to develop and implement the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD), which will enable clinical investigators, NCI, FDA, and industry entities sponsoring clinical trials of investigational drugs ("Sponsors of Drugs and Biologics" or "Sponsors") to manage clinical investigator information electronically in a fully secure manner.