Funded by the NIH Naonal Center for Advancing Translaonal Sciences through its
Clinical and Translaonal Science Awards Program, grant number UL1TR001102-04S1.
www.smarrb.org
Harmonized: This document underwent a review and input process from December 2020 to April 2021 and has now been nalized.
SAMPLE AUDIT CHECKLIST

A. REGULATORY DOCUMENTATION
1. Is the approved protocol on le? (Original and all previously approved versions?) □ Yes □ No
1.1 Is the IRB Approval Leer(s) on le? □ Yes □ No
1.2 Is this an FDA regulated study? (If no, go to 1.3) □ Yes □ No □ N/A
1.2.1 Is there a signed FDA 1572 on le? □ Yes □ No
1.2.2 Are all versions of the Invesgator Brochure or package insert on le? □ Yes □ No
1.2.3 Are all versions of the package insert or device manual on le? □ Yes □ No
1.2.4 Is all correspondence to and from the FDA on le? □ Yes □ No
1.3 CVs of PI/Co-PI and all study sta on le? □ Yes □ No □ N/A
1.3.1 For all CVs on le, are they current in alignment with applicable requirements? □ Yes □ No
1.3.2 For all CVs on le, are they signed and dated, if required? □ Yes □ No
1.3.3 Is there a sta training log? □ Yes □ No
1.3.4 Is the sta training log complete and up-to-date? □ Yes □ No
1.4 Is there a subject enrollment log? □ Yes □ No
1.4.1 Is the subject enrollment log complete? □ Yes □ No
1.5 Is/will the site (be) monitored? □ Yes □ No
1.5.1 Who is the monitoring body?
1.5.2 How oen?
1.5.3 Is there a monitoring log? □ Yes □ No
1.5.4 If yes, is the monitoring log complete? □ Yes □ No
1.6 Is there a sta signature and delegaon of responsibilies log? □ Yes □ No □ N/A
1.6.1 Is the sta signature and delegaon log complete and up-to-date? □ Yes □ No
1.7 Is all correspondence to and from the sponsor on le? □ Yes □ No □ N/A
1.8 Are lab tests required? □ Yes □ No □ N/A
1.8.1 If yes, is a copy of normal lab values on le? □ Yes □ No
1.8.2 Is a copy of the lab cercaon on le? □ Yes □ No
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Funded by the NIH Naonal Center for Advancing Translaonal Sciences through its
Clinical and Translaonal Science Awards Program, grant number UL1TR001102-04S1.
www.smarrb.org
Harmonized: This document underwent a review and input process from December 2020 to April 2021 and has now been nalized.
REGULATORY DOCUMENTS COMMENTS/ISSUES:
B. SUBJECT RECRUITMENT PROCEDURES
2. How are parcipants idened for the study?
2.0.1 Are there recruitment materials for this study? □ Yes □ No
2.0.2 Are all recruitment materials IRB approved? □ Yes □ No
2.0.3 Are all currently approved recruitment materials on le? □ Yes □ No
SUBJECT RECRUITMENT PROCEDURES COMMENTS/ISSUES:
C. INFORMED CONSENT PROCESS
□ Secon not applicable (consent waived)
3. Is wrien consent required to be obtained by the IRB approved protocol? □ Yes □ No
3.1 If yes, how many versions of the consent form are there?
3.2 Have any eligible subjects been enrolled in this study? □ Yes □ No

For the consent forms and documentaon reviewed, complete the following quesons:
3.3 How many subjects are/were enrolled to date?
3.4 How many subjects is/was the site approved to enroll?
3.5 How many subjects were chosen for review?
DATE APPROVED EXPIRATION DATE
MASTER COPY OF APPROVED
CONSENT FORM ON FILE? (Y/N)
2
Funded by the NIH Naonal Center for Advancing Translaonal Sciences through its
Clinical and Translaonal Science Awards Program, grant number UL1TR001102-04S1.
www.smarrb.org
Harmonized: This document underwent a review and input process from December 2020 to April 2021 and has now been nalized.
3.6 Did each subject or their LAR sign his/her own consent form? □ Yes □ No
3.7 Did each subject date his/her own consent form? □ Yes □ No
3.8 Was the current approved consent document used for each subject? □ Yes □ No
3.9 Are any parcipants minors?  □ Yes □ No
3.9.1 Is there evidence of assent? □ Yes □ No
3.9.2 Did the parent(s) or guardian sign and date properly? □ Yes □ No
3.10 Did the study sta sign the consent? □ Yes □ No
3.11 Did the signing study sta date the signed consent? □ Yes □ No
3.12 Did anyone not approved by the IRB to consent subjects sign as study representave? □ Yes □ No
3.12.1 If yes, who?
3.13 Does the signature date prior to all approved research procedures? □ Yes □ No
3.14 Did each subject receive a copy of the signed and dated consent form? □ Yes □ No
3.15 Is subject’s receipt of a copy of the signed consent form documented? □ Yes □ No
3.16 If consent was revised were subject re-consented or noed as required by the IRB? □ Yes □ No
INFORMED CONSENT PROCESS COMMENTS/ISSUES:
D. SUBJECT SELECTION
□ Secon not applicable (no subjects enrolled)
4. Is there documentaon of subject eligibility (note format used)? □ Yes □ No
4.1 Did all subjects meet eligibility criteria? □ Yes □ No
4.2 If no, were they excluded appropriately? □ Yes □ No
4.2.1 If no, was a protocol deviaon submied to the IRB? □ Yes □ No
SUBJECT SELECTION COMMENTS/ISSUES:
3
Funded by the NIH Naonal Center for Advancing Translaonal Sciences through its
Clinical and Translaonal Science Awards Program, grant number UL1TR001102-04S1.
www.smarrb.org
Harmonized: This document underwent a review and input process from December 2020 to April 2021 and has now been nalized.
E. IRB REPORTING AND OVERSIGHT
5. Were study procedures conducted following inial IRB approval? □ Yes □ No
5.1 Were changes to study procedures only implemented aer IRB approval was received? □ Yes □ No
5.2 Were study procedures conducted during a period of expiraon or suspension? □ Yes □ No
IRB REPORTING AND OVERSIGHT COMMENTS/ISSUES:
F. STUDY CONDUCT
6. Were study assessments/evaluaons performed according to protocol? □ Yes □ No
6.1 Were study tests/procedures completed at the me intervals described in the protocol? □ Yes □ No
STUDY CONDUCT COMMENTS/ISSUES:
G. ADVERSE EVENTS
7. Were adverse events monitored and recorded as described in protocol and Reviewing IRB’s
policies and assessed by appropriately qualied and delegated individuals in a mely manner? □ Yes □ No
ADVERSE EVENTS COMMENTS/ISSUES:
H. DATA MANAGEMENT & SECURITY
8. Is source documentaon and data collecon accurate, complete and appropriately transcribed? □ Yes □ No
8.1 Is the data store and transmied (if applicable) securely? □ Yes □ No □ N/A
8.2 Does documentaon support that the DSMP is being followed and that safety/data reviews
are occurring according to the approved schedule? □ Yes □ No
DATA MANAGEMENT & SECURITY COMMENTS/ISSUES:
4
Funded by the NIH Naonal Center for Advancing Translaonal Sciences through its
Clinical and Translaonal Science Awards Program, grant number UL1TR001102-04S1.
www.smarrb.org
Harmonized: This document underwent a review and input process from December 2020 to April 2021 and has now been nalized.
SUMMARY OF COMMENTS AND ADDITIONAL ISSUES:
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