miércoles, 13 de julio de 2011

Drug Approvals and Databases > Bioresearch Monitoring Information System (BMIS)

Drug Approvals and Databases > Bioresearch Monitoring Information System (BMIS): "Bioresearch Monitoring Information System (BMIS)

The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs.

Update frequency: Quarterly

The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs. The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission. For example, if an investigator is named in 10 INDs, his/her name will appear 10 times in this file.


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