Is the Following Regulatory Documentation Maintained?

Institutional Review Board

FORM L: SELF-ASSESSMENT TOOL

IRB #
PI / Title of Research
Faculty Advisor / Date Completed

Section A: Regulatory Review

A-1 / Are all staff working on the study listed on the IRB submission? / YES / ☐ / NO / ☐ / N/A / ☐ /
If not, was this reported to the IRB? / YES / ☐ / NO / ☐ / N/A / ☐ /
A-2 / Is CITI certification current for all investigators listed on the protocol? / YES / ☐ / NO / ☐ / N/A / ☐ /
If not, please provide details: Click or tap here to enter text.
A-4 / IRB-approved subject size: Click or tap here to enter text.
A-5 / Number of subjects who signed consent (enrolled) to date: Click or tap here to enter text.
A-6 / Is the IRB approved plan for data storage and data security being followed? / YES / ☐ / NO / ☐ / N/A / ☐ /
A-7 / Has study data been disposed of, or will it be disposed of per the approved protocol procedures? / YES / ☐ / NO / ☐ / N/A / ☐ /
If not, please provide details: Click or tap here to enter text.
A-8 / Have all protocol deviations/protocol non-compliance and/or non-compliance with IRB Policies and Procedures, federal regulations, or university regulations been reported to the IRB? / YES / ☐ / NO / ☐ / N/A / ☐ /
A-9 / Have any subjects indicated concern with the study or informed consent procedures or experienced an adverse event? / YES / ☐ / NO / ☐ / N/A / ☐ /
If yes, was this reported to the IRB? / YES / ☐ / NO / ☐ / N/A / ☐ /
In no, please describe the situation and how it was handled: Click or tap here to enter text.

Is the following Regulatory Documentation maintained?

A-10 / Approved IRB Protocol / YES / ☐ / NO / ☐ / N/A / ☐ /
A-11 / IRB Approval Letter / YES / ☐ / NO / ☐ / N/A / ☐ /
A-12 / Annual Renewal Approval Letters / YES / ☐ / NO / ☐ / N/A / ☐ /
A-13 / Modifications to Protocol / YES / ☐ / NO / ☐ / N/A / ☐ /
A-14 / Record of IRB Approval of Modifications / YES / ☐ / NO / ☐ / N/A / ☐ /
A-15 / Evidence of Investigator CITI Training / YES / ☐ / NO / ☐ / N/A / ☐ /
A-16 / Approved Informed Consent Letter / YES / ☐ / NO / ☐ / N/A / ☐ /
A-17 / Approved Recruitment Materials / YES / ☐ / NO / ☐ / N/A / ☐ /

Section B: Documentation Review

Please provide copies of the following documents:

B-1 / Actual Consent Letter that is/was used / Attached / ☐ / N/A / ☐ /
B-2 / Actual recruitment materials that are/were used / Attached / ☐ / N/A / ☐ /

Section C: Additional Comments/Concerns

CC-1 / Please describe any special circumstances encountered during your project that the IRB should be made aware of. Click or tap here to enter text.
CC-2 / Overall, have you found working with the UTC IRB to be a satisfactory experience? Click or tap here to enter text.

Signatures:

Principal Investigator or Student / Date
*Faculty Advisor (for student applications) / Date

* If submitted by a faculty member, electronic (typed) signatures are acceptable. If submitted by a student, please print out completed form, obtain the faculty advisor’s signature, scan completed form, and submit it via email. Only Word documents or PDF files are acceptable submissions.

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