Has the subject experienced any adverse events
Adverse Event Log
Has the subject experienced any adverse events? YES NO (Complete at End of Study)
Record all Adverse Events that occur during the study period (may be defined as ‘from signing consent to conclusion of study participation’. Elicit adverse event information by asking open-ended questions, e.g. ‘What unusual symptoms or medical problems have you experienced since the last study visit?’ Record any new or change in ongoing signs and/or symptoms as well as any event that has resolved since the last evaluation. IF EVENT IS A SERIOUS ADVERSE EVENT (SAE), you may need to complete additional reporting and/or documentation for the IRB or Sponsor. Consult approved protocol and applicable policies to determine reporting responsibility.
AE # |Adverse Event Description |Start/Stop Dates |Severity |Action taken with Study Drug |Outcome |Relation To Study Drug (to be completed by Investigator) |Is this a Serious Adverse Event? |Investigator Signature and Date | |1 | |
___/___/____
Start
___/___/____
Stop
|
Mild ___
Moderate ___
Severe ___ |
None ___
Discontinued ___
Interrupted ___
|
RECOVERED w/o sequela ____
RECOVERED w/ sequela ____
Ongoing ____
Fatal ____
UNK ____ |
Definite ___
Probable ___
Possible ___
Not Likely ___
Unrelated ___ |
□ Yes *
□ No
| | |2 | |
___/___/____
Start
___/___/____
Stop
|
Mild ___
Moderate ___
Severe ___ |
None ___
Discontinued ___
Interrupted ___
|
RECOVERED w/o sequela ____
RECOVERED w/ sequela ____
Ongoing ____
Fatal ____
UNK ____ |
Definite ___
Probable ___
Possible ___
Not Likely ___
Unrelated ___ |
□ Yes *
□ No | | |3 | |
___/___/____
Start
___/___/____
Stop
|
Mild ___
Moderate ___
Severe ___ |
None ___
Discontinued ___
Interrupted ___
|
RECOVERED w/o sequela ____
RECOVERED w/ sequela ____
Ongoing ____
Fatal ____
UNK ____ |
Definite ___
Probable ___
Possible ___
Not Likely ___
Unrelated ___ |
□ Yes *
□ No | | |
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