Adverse Event Tracking Log

Institutional Review Board

CONTINUING REVIEWDEVIATION/WAIVER TRACKING LOG

To provide a history of deviations, violations and subject-specific sponsor waivers for this protocol, maintain an accumulative log. This tracking log should be used for deviations that donot require prompt reporting to the IRB because they do not involve harm or risks for the subject. Using this form, these 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. Deviations that did require prompt reporting to the IRB using the Deviation Report Form should also be added to the log for tracking purposes.

IRB Number:

Protocol Title:

Principal Investigator: Department: Phone: () -

Date of Occurrence / Type of Deviation / Caused by / Brief Description of Deviation / Steps Taken to Prevent Future Occurrence
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther
Eligibility criteriaVisit scheduleDose or dose scheduleUse of meds not allowedLab valuesRecruitment/ConsentOther / Staff ErrorSubject ErrorCircumstanceOther

Internal Cont Review AE/Event Log – 03-09Page 1 of 1