Office of the Associate Vice Chancellor for Compliance

News Archive

 

July 20, 2006
Adverse Events

The KUMC Human Subjects Committee announces new guidelines for reporting external adverse drug events in multi-center clinical trials. The new guidelines apply when the adverse events in a multi-center drug trial are being reviewed by a central monitoring entity, such as a data and safety monitoring board, a data monitoring committee or other central safety monitoring arrangement. A revised External Problems Form and instructions are posted at: http://www2.kumc.edu/researchcompliance/hscforms.htm.