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:
- Patient’s 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.
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