SOP11v5 SOP for identifying, recording and reporting adverse by 8ZuEVs

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									             ADVERSE EVENT FLOWCHART – REPORTING
                         From time participant is consented:
               ADVERSE EVENT REPORTING REQUIREMENTS
                AE observed (as defined in ACCORD SOP CR005/CR006).



                         Is it serious (according to seriousness criteria
                         described in ACCORD SOP CR005/CR006)?



                          YES                                        NO


      It is a Serious Adverse Event                            It is an Adverse Event
         (SAE). All SAEs must be                             (AE). This does not require
     reported on an SAE Form and                                 expedited reporting.
       faxed to +44 (0)131 242 9447                             Record on CRF only.
      within 24 hours of becoming
             aware of the event.



             Is the event related to the IMP? For trials involving NIMPs, is the
            event related to an interaction between the IMP and NIMP, or is the
                event linked to either the IMP or NIMP and cannot be clearly
                              attributed to either one of these?


                       YES                                                NO


       Is the event expected                                    It is a Serious Adverse Event
        (i.e. is it listed in the                                  (SAE). All SAEs must be
        summary of product                                     reported on an SAE Form and
           characteristics)?                                     faxed to +44 (0)131 242 9447
                                                                within 24 hours of becoming
                                                                       aware of the event.
    YES                             NO


It is a Serious Adverse                    The event is a SUSAR. This must be
  Reaction (SAR). All                    reported on an SAE Form and a SUSAR
      SARs must be                        Form and both should be faxed to +44
  reported on an SAE                         (0)131 242 9447 with 24 hours of
Form and faxed to +44                          becoming aware of the event.
(0)131 242 9447 within
 24 hours of becoming
   aware of the event.
                                         SUSARs will be reported by ACCORD on
                                         behalf of the investigator to the MHRA and
                                         main REC within 7 days for life threatening
                                         or fatal SUSARs and within 15 days for all
                                                        other SUSARs.

                                         CR005-T02v2.0

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