ADVERSE EVENT LOG
____________________________________________________________________________________________________________
Study Title:
Protocol No:
S.No.
Subject
ID
Adverse
Event
Site ID:
Serious1
Yes
No
Yes
No
Yes
No
Severity2
Mild
Moderate
Severe
Lifethreatening
Mild
Moderate
Severe
Lifethreatening
Mild
Moderate
Severe
Lifethreatening
Relationship
to Inv. Agent
Unrelated
Possible
Probably
Definitely
Unrelated
Possible
Probably
Definitely
Unrelated
Possible
Probably
Definitely
Project Code:
Start
Date/Time
(dd/mm/yyyy)
(24Hrs)
Date:
End
Date/Time
(dd/mm/yy
yy) (24Hrs)
Date:
Time:
Time:
Date:
Date:
Time:
Time:
Date:
Date:
Time:
Time:
Investigator
Initial and
Date
NOTE:
Page 1 of 2
Comments3
ADVERSE EVENT LOG
____________________________________________________________________________________________________________
1: If the adverse event is considered serious, complete a Serious Adverse Event Form and Log.
2: The definitions of severity are the following:
Mild – Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required.
Moderate – Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy
required.
Severe – Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations
possible.
Life threatening – Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required
hospitalization or hospice care probable.
3. Treatment or Procedure or Study Discontinuation (Please Specify)
Signature of the Principal Investigator:
Date:
Page 2 of 2