ADVERSE EVENT LOG - UNC Research
ADVERSE EVENT
Make a separate entry for:
➢ All new adverse events
➢ All AEs with increased severity
➢ All AEs with changes in study drug relationship
➢ All medical conditions present at study drug initiation which have worsened |
( if AE meets definition of serious* |
Grade / Intensity
Asymptomatic
Mild
Moderate
Severe
|
Start Date |
End Date
|
Relationship to study intervention
Related
Possibly
Not Likely
Not Related
|
Was Action Taken?
(Circle One)
|
Action(s) Taken^:
|
Outcome:
Recovered
Not Recovered
Recovered
w/Sequelae
Fatal
Unknown |
PI Initials / Date | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | | | | | | | |Yes / No | | | | |
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