HRPP / Protocol Checklist
sIRB Review / CHK-03H043
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Protocol reviewed: / Review completed by:
Protocol #:
PD: / Name:
Date: / IRB#:
Yes / No / N/A / Protocol Checklist /
Personnel Info: All required personnel have completed CITI training
Personnel Info: If the study meets the definition of a clinical trial, send out “GCP” comment code asking investigators to confirm they have completed GCP training.
Personnel Info: Protocol Director appropriate for the study
Single IRB Information: Check to see if a master agreement exists with the reviewing IRB
Study Location: Stanford University selected
General Checklist: If marked yes to question 1 Tissues and Specimens, sIRB review not accepted at this time
General Checklist: If marked yes to Veterans Affairs (VA), sIRB review not accepted at this time
General Checklist: If Cancer-Related Study, request SRC review date or approval
General Checklist: If Stanford is responsible for registering the study on clinicaltrials.gov, ask for NCT #
General Checklist: If bringing in/sending out identifiable data or specimens AND if there is no contract with sponsor, send DUA and/or MTA comment
General Checklist: If marked yes to APB questions, email Susan Vleck and then assign Susan to reviewGeneral Checklist: If marked yes to Radioisotopes/radiation-producing machines, assign to radiation safety reviewers
Funding: If federally funded and Stanford prime awardee of grant, the federal grant should be attached to section 7. If ‘Other’ is checked as Administrator of grant, ask for clarification.
Funding: Request SPO# and/or confirm the SPO is correct.
eP section 2: Includes all standard of care and research procedures using ionizing radiation
eP section 3 and 4: if IDE or IND held by Stanford Investigator, add SIR admin note and confirm with Senior Compliance Analyst PD has completed SIR training
eP section 4: If the Investigational drug will not be controlled by a pharmacy, the PD has provided a Security and Controlled Access Plan
eP section 5: OPACS completed for all listed Investigators
eP section 5: If COI indicated, action report has been received and attached to section 7 and appropriate language added to consent form.
eP section 6: Confirm reviewing IRB will serve as Privacy Board, if not request Waiver of HIPAA Authorization for Recruitment as applicable
eP section 7: Confirm IRB Reliance Agreement (IAA, MOU, or Waiver of Jurisdiction) has been attached. Agreement to be signed by Katherine Ho. Will need to be signed by both parties (fully executed) before approval of sIRB application.
eP section 7: Stanford site approval from reviewing IRB attached in section 7.
eP section 7: Consent Form includes Stanford required HIPAA Authorization language, in 14 point font and with HIPAA expiration date (unless repository which allows ‘end of study’ as expiration).
eP section 7: Consent Form includes Stanford template ‘Costs’ language as appropriate
eP section 7: Consent Form includes Stanford’s Option 1 or Option 2 Research Related Injury template language. If correct language not included, may require Risk Assessment Committee (RAC) review
CHK03H043 rev1 5/17 Research Compliance Office