CHECKLIST: External IRB review of UC Davis Human Subject ResearchNUMBER DATE PAGEHRP-442 06/18/2019 1 of 2

The purpose of this checklist is to provide support for IRB staff conducting Pre-review. This checklist or equivalent is to be completed by the IRB staff, signed, dated, and retained.

IRB Number:

Protocol Name:

Investigator:

Funding

Reviewing IRB:

Pre-Review ☐ A current, executed Reliance Agreement exists and, as applicable is uploaded to submission and an electronic archive. ☐ The human subject research is minimal riskOr☐ The human subject research is greater than minimal risk and reviewing IRB is accredited by AAHRPP or equivalent bodyOr☐ The human subject research is greater than minimal risk and reviewing IRB has an internal quality review process to ensure compliance with ethical principles, applicable law and guidance and Director or Associate Director has agreed to cede review. ☐ Confirm billing information for IRB review fees as applicable.☐ N/A☐ The UC Davis Investigator is not Restricted and has completed required training.☐ The package includes the following items:

Abbreviated initial review application Protocol Subject facing materials Investigator Brochures Local ancillary approval determinations and any other approved documents Approval letter of the external, reviewing IRB The reliance agreement (when necessary and/or not on file with IRB Administration)

Initial Administrative Review ☐ The protocol is complete and understandable. ☐ The protocol is consistent with UC Davis requirements and applicable law. ☐ If consent is not waived or consent alteration granted, the consent document and process is consistent with UC Davis SOP HRP-090-091

(with the exception of HRP-091 5.1.2.1.2), when applicable. ☐ If consent is altered or waived, the requirements for an alternation or waiver of consent are met consistent with UC Davis SOP HRP-410-411.☐ N/A - Consent is not altered or waived.☐ If documentation of consent is waived, the requirements for a waiver of documentation of consent are met and the research does not include

a “medical experiment” as defined by California law. ☐ N/A - Documentation of consent is not waived.☐ If there is a local COI, the consent document is consistent with the management plan.☐ N/A - No COI reported.☐ The research is acceptable; there is no apparent error or omission in the approval of the reviewing IRB based on regulatory criteria for

approval of human subjects research.☐ This study is greater than minimal risk and/or subject to FDA regulations and will undergo at least annual review.☐ N/A - Study is minimal risk and not subject to FDA regulations.☐ The study involves an exception from the requirement for informed consent under 21 CFR 50.24, it has been reviewed by the IRB Director

and the Chair of Committee A or B. ☐ N/A – There is no exception from the requirement for informed consent under 21 CFR 24

Administrative Review of Active Research ☐ There is a modification/report involving an exception from the requirement for informed consent under 21 CFR 50.24 and it has been

CHECKLIST: External IRB review of UC Davis Human Subject ResearchNUMBER DATE PAGEHRP-442 06/18/2019 2 of 2

reviewed by the IRB Director and the Chair of Committee A or B. ☐ N/A – There is no exception from the requirement for informed consent under 21 CFR 24☐ There is a report of an unanticipated problem involving risk to subjects or others or serious or continuing noncompliance. (Read and follow

SOP 058 to ensure reporting requirements are met.) . ☐ N/A – There is no report an unanticipated problem involving risk to subjects or others or serious or continuing Comments:

☐ Acknowledgement sent to Relying Investigator (the automated message from IRBNet regarding protocol status is adequate)

OR

☐ Any deficiency in documentation or other item that precludes acknowledgment is conveyed to the PI for reconciliation with criteria for approval