Minor Deviations/Violations Tracking Log

Protocol violations are any deviations from the IRB-approved protocol that are not approved prospectively by the IRB. Major protocol violations are deviations from the IRB approved protocol that impact subject safety, compromise the integrity of the study/data, and/or affect the subject's willingness to participate in the study. Minor protocol violations are those that do not. Minor violations include, but are not limited to, protocol deviations such as out of window visits, missing tests/labs, missing original/signed consent form (copy exists), missing PI signature on consent form(s), use of expired/outdated consent form that includes all relevant information, over-enrollment, failure to submit continuing review prior to expiration of IRB approval. For more information, refer to PHRC policy Protocol Deviations, Exceptions, and Violations.

Instructions: This log is to be used for tracking and reporting minor deviations/violations. The log must be submitted at continuing review for review by the
IRB. Minor deviations/violations are to be reported ONLY at continuing review. NOTE: Entries in the log must be typed. PI: Dr. Srdjan Nedeljkovic Protocol # 2010p000000 Title: Bold Study- RCT Sponsor: AHRQ Date Date Subject Deviation Deviation Study ID Discovered Occurred 8/2/2011 4/21/2011 32-00005

Description of Deviation

Description of Corrective Action

Date Sponsor Notified

Date Recorded Sponsor by / Date Approved 8/3/2011

Patient did not complete part of the questionnaire

Reemphasize on the fact that patient questionnaires are verified by the study staff after completion and any missed questions are answered to. Timely reminder to the subject to complete the diary and provide assistance when required. Record all the items of the screening process on to the sreening form.

8/2/2011

5/31/2011 32-00013

The study diary handed over to the subject came back partly incomplete One of the questionnaires in the Screening form was left blank.

8/3/2011

8/3/2011

6/10/2011 32-00037

8/3/2011

8/5/2011 exception8/9/2011 8/5/2011

32-00042

Patient having a procedure outside the Can be made an exception window period for her 6 week injection. considering the condition of the Window closes 8/8/2011 patient and physician availability Patient supposed to have her 6 week Monitor INR again, contacr other procedure in the morning did not satisfy attending Physicians of the patient, one of the pre-requisites as she was confirm and schedule a procedure having an INR of 1.4 and the cut-off was 1.3 Patient had his week 3 treatment 5 days earlier than the window in which he was supposed to get his treatment. He had it on 6/17/2011 when the window opened on 6/22/2011 Schedule the patient visits in their windows considering Physicain availaility and the choice of the patient.

8/8/2011

8/5/2011 32-00042

8/8/2011

8/5/2011

6/17/2011 32-00023

8/8/2011

Minor Deviations/Violations Tracking Log

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8/5/2011

7/8/2011 32-00023

Patient had his week 6 treatment 12 Schedule the patient visits in their days earlier than the window in which he windows considering Physicain was supposed to get his treatment. He availaility and the choice of the had it on 7/20/2011 when the window patient. opened on 7/8/2011

8/8/2011

Minor Deviations/Violations Tracking Log

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