NON-COVID-19 Human Subjects Research (Pediatrics)

Submit this form to request local approval for non-COVID19 human subjects research initiation or resumption per the guidance in the Cardinal Recovery Handbook, for Stage 3 Clinical Human Subjects Research (https://cardinalrecovery.stanford.edu/research/research-recovery/). The Pediatrics Restart Research Committee will review and provide approval / denial. Please email Crystal Botham (cbotham@stanford.edu) with any questions regarding this process.

Protocol Director (PD) / Principal Investigator (PI) Name

PD / PI Email

PD / PI Division

Is this an activation of a new study or re-activation of a previously open study?

Activation of new study

Re-activation of a previously open study

IRB e-protocol number

Study title

Estimated open to enrollment date or next research visit date

Are patients eligible for this study already coming to SHC or LPCH for clinical care such that the research activities/visit would piggy-back off of their clinical visit?

Yes

Will in-person human subjects research associated with a clinical visit in the clinical setting (SCH/SHC) take place in another SoM or non-SoM building on the same day or different day as the clinical visit?

If yes, note SoM or non-SoM buildings in the study description or patient-facing questions below.

Yes

Brief study description

Is this a clinical trial?

Yes

Describe your research subject sample (e.g., infants, children, younger adults, older adults).

Describe the nature and frequency of required downstream basic lab-based research and/or non-patient facing clinical research activities at Stanford.

List all Stanford buildings where downstream basic lab-based research and/or non-patient facing clinical research activities will take place.

List names and job titles required for all basic lab-based research and/or non-patient facing clinical research activities.

If approved, will patient-facing clinical research staff be required?

Submitter email address, if different from PD / PI

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