Appendix C. Sample Protocol Deviation Log Protocol Name:________________________________________________________________________ Protocol Participant Initials Participant Date Deviation Date Protocol Contact Person Deviation Code: ID# Occurred: Deviation Form (if applicable) mm/dd/yyyy Completed: mm/dd/yyyy SAMPLE PROTOCOL DEVIATION CODES Consent Form: reporting a serious complication within 24 hours; Missing or not obtained not kept up to date Not signed and dated by participant and/or treatment occurs prior to IRB Does not contain all required signatures approval or during period when on hold” “on Outdated, current IRB-approved version not used serious adverse events not reported to IRB Not protocol-specific Participant Does not include updates or information required by the wrong treatment IRB occur outside expected follow-up window Randomization: into another study Ineligible participant enrolled and/or randomized Study Data and/or Forms Participant randomized prior to determining whether data and/or forms eligible for study radiology and/or operative reports Occurs outside protocol window or data not sent from clinical site to coordinating IRB: center
Appendix C. Sample Protocol Deviation Log Protocol Name:________________________________________________________________________ Protocol Deviation Code: Participant Initials Participant ID# Date Deviation Occurred: mm/dd/yyyy Date Protocol Deviation Form Completed: mm/dd/yyyy Contact Person (if applicable) SAMPLE PROTOCOL DEVIATION CODES Consent Form: Missing or not obtained Not signed and dated by participant Does not contain all required signatures Outdated, current IRB-approved version not used Not protocol-specific Does not include updates or information required by the IRB Randomization: Ineligible participant enrolled and/or randomized Participant randomized prior to determining whether eligible for study Occurs outside protocol window IRB: reporting a serious complication within 24 hours; not kept up to date and/or treatment occurs prior to IRB approval or during period when on “on hold” serious adverse events not reported to IRB Participant wrong treatment occur outside expected follow-up window into another study Study Data and/or Forms data and/or forms radiology and/or operative reports or data not sent from clinical site to coordinating center
MOP_NCCIH_ver1_07-17-2015.docx