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The IRB is responsible for reviewing reports of any adverse events or unanticipated problems involving risks to subjects or others. The following must be reported immediately, within 7 calendar days, except where "within 24 hours" if the protocol deviation was made in order to eliminate an apparent immediate hazard to a participant:
  • Patientís coded ID number
  • Date of Report
  • Kind of report ( i.e. Initial, FU#1, etc.)
  • Adverse event
  • Opinion of Investigator whether or not protocol related

It is very important to write your opinion about the adverse events that are probably or possibly related to the study drugs and what steps, if any they are going to take to minimize risk to your patients.