Bioresearch Monitoring Program

Initial planning under the Bioresearch Monitoring Program called for each testing facility to be inspected yearly. It was later decided that a biennial inspection would suffice to ensure that all 2-year studies would be inspected at least once while in progress. 

First, the people responsible for FDA s bioresearch monitoring program are encouraged by the results of the GLP inspection seen in terms of industry s growing acceptance of the GLPs as a means of establishing a level of reliability for scientific testing. 

FDA conducts the following three types of inspections through its Bioresearch Monitoring Program (Information Sheets, 1998) ... 

The FDA stepped in to assist this evolution after the trial monitoring program in 1972 to 1974. The FDA launched its Bioresearch Monitoring Program in... 

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Bioresearch Monitoring (BIMO), Good Laboratory Practice, Compliance Program 7348.808. 

US FDA. Compliance Program Guidance Manual, Program 7348.808, Chapter 48, Bioresearch Monitoring, Good Laboratory Practice, Completion Date 09/03/93. http //www.fda.gov/ora/compliance ref/bimo/7348 808/48-808.pdf... 

Compliance Program 7348.811 - Bioresearch Monitoring - Clinical Investigators, FDA, 1997. http //www.fda.gov/ora/com-pliance ref/bimo/7348 811/defanlt.htm http //www.fda.gov/ ora/ftparea/compliance/48 811.pdf... 

FDA (1992) Bioresearch monitoring—institutional review boards. In Compliance Program Guidance Manual, Program 7348.809, January, Chapter 48. 

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