Adverse Event Tracking Log

Institutional Review Board

INTERNAL CONTINUING REVIEW ADVERSE EVENT/PROBLEM TRACKING LOG

(NON-SERIOUS, POSSIBLY RELATED AND UNANTICIPATED, AS WELL AS DEATHS)

To provide a history of known internal events/problems for this protocol, maintain an accumulative log for the internal events/problems that are not problems that require prompt reporting to the IRB. Using this form, these events/problems should be reported to the IRB with the yearly Application for Continuing Review and at the close of the study. Attach all correspondence concerning the following events that has occurred with the sponsor. Internal events that are anticipated or not related to the research do not need to be recorded on this log except for deaths.

IRB Number:

Protocol Title:

Principal Investigator: Department: Phone: () -

Date of Event / Event’s Identifying Code
(if any) / KEYWORDS for the Event
(10 or less) / Event Frequency/Severity
are consistent
with consent form
(Yes/No) / If a Death choose
Progression of Disease or Unrelated
If not Death choose NA / Unanticipated (Yes/No) / Related/
Possibly Related
(Yes/No) / Date
Submitted
to IRB
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes
YesNo / Progression of DiseaseUnrelatedN/A / NoYes / NoYes

Internal Cont Review AE/Event Log – 08-10 Page 1 of 1