SERIOUS ADVERSE EVENTS LOG by 90pxdVME

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									                           SERIOUS ADVERSE EVENTS LOG
                                                         (SAEs occurring at this site)

Investigator: ______________________________________                       Project: ________________________________________

Study Site:   ______________________________________                       Sponsor: ________________________________________

                Date                                                                       Study SAE            Date Reported to      Date
Date SAE      Learned      Subject                                                           Form                  Sponsor*        Reported to
                                                            Event
Occurred      of Event    Identifier                                                       Completed                                 IRB**
                                                                                              (Y/N)




                      *If required by the Sponsor (see protocol for Sponsor requirements)
                     **If required by the IRB (see IRB requirements on SAE reporting, i.e., definitions & timeframes

                                                                 Compliments of:

                                                                  SMART
                                                Site Monitoring, Auditing and Resource Team
                                                      VA Cooperative Studies Program
                                                              Albuquerque, NM
                                                                                                                                      4/13/05

								
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