Adverse Event Form
STUDY NAME
Site Number:
Pt_ID:
Has the participant had any Adverse Events during this study? Yes No (If yes, please list all Adverse Events below)
Severity
1 = Mild
2 = Moderate
3 = Severe
Study Intervention
Relationship
1 = Definitely related
2
=
Possibly re
lated
3 = Not related
Adverse Event Last updated 14JUN2019
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Action Taken Regarding Study
Intervention
1 = None
2 = Treatment Stopped
3 = Treatment Interrupted
4 = Reduced Dose
5 = Increased Dose
6 = Delayed Dose
Outcome of AE
1 = Resolved, No Sequel
2 = AE still present- no treatment
3 = AE still present-being treated
4 = Residual effects present-not treated
5 = Residual effects present- treated
6 = Death
7 = Unknown
Expected
1 = Yes
2 = No
Serious
1 = Yes
2 = No
(If yes,
complete SAE
form)
Adverse Event
Start Date
Stop Date
Severity
Relationship to
Study Treatment
Action
Taken
Outcome
of AE
Serious
Adverse
Event?
PI
Initials
& Date
1.
2.
3.