1.1
Study name
1.2
Protocol number (METC/ABR)
1.3
Sponsor
1.4
Subject ID
1.5
Has the participant had any Adverse Events during this study?
An Adverse Event is any undesirable experience occuring to a subject during the study, whether or not considered related to the investigational product, trial procedure or the experimental intervention.
2.1
Description Adverse Event
2.2
Start Date
2.3
Stop Date
2.4
Severity
2.5
Relationship to Study Procedure(s)
2.6
Action taken regarding study procedure(s)
2.7
Outcome of adverse event
2.8
Expected?
2.9
Meets criteria Serious Adverse Event
**If yes, complete SAE form**
2.10
Initials Principal Investigator
Yes/No
Severity
Relationship study intervention
Action taken
Outcome AE