ADVERSE EVENT TRACKING LOG STUDY TITLE PRINCIPAL INVESTIGATOR STUDY

Definitions 100 Series Avoid Adverse Impacts Means to
0 REPORT ON ADVERSE DRUG REACTION 1 REPORTER (DOCTOR
A DVERSE EVENT NOTIFICATION FORM CHAPTER 7056 ADVERSE HEALTH

ADVERSE EVENT (AE) REPORTING FORM INSTITUTIONAL REVIEW BOARD (IRB)
ADVERSE EVENT FORM STUDY NAME SITE NUMBER PTID
ADVERSE EVENT REPORT SGU IRB APPLICATION REFERENCE ADVERSE EVENT

SERIOUS ADVERSE EVENT TRACKING LOG (SITE)

ADVERSE EVENT TRACKING LOG


Study Title:


Principal Investigator:


Study Coordinator:




Subject ID

Start Date

of Event

*Date Event

Resolved

Description of Event

Severity of

Event

Nature of

Event

Relationship

of Event

Action with study drug

1- No Action

2- Interrupted

3- Discontinued


Is this a UP involving risks to subjects or others?

**Date Report

Sent to HRPP


1












2












3












4












5












6












7












8












9












10












* All events should be resolved or noted as unresolved at the time of subjects discontinuation in the study (i.e. study complete or subject withdrawal)

** Report all adverse events in accordance with HRPP Guidelines.



ADVERSE EVENT REPORTING FORM SECTION I INSTRUCTIONS FORMS
ADVERSE EVENT SUMMARY V 50 N (INCLUDE NUMBER
ADVERSE EVENT TRACKING LOG STUDY TITLE PRINCIPAL INVESTIGATOR STUDY


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