PN1 Console/External Systems/CIRBI Platform

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IRB Portal · Advarra

CIRBI Platform

Submit protocol amendments, continuing reviews, deviations, and safety letters; receive approval documentation.

Submit Amendment

Amendment # *Summary of changes *Risk to subjects *Target approval

Simulation only — saved locally to this browser, never sent to the vendor

Training notes

· Prompt reporting: unanticipated problems within 10 business days.
· Continuing review submission is due ≥30 days before approval expires.
· IRB acknowledgement is a required eTMF artifact (04.01 series).

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CTMSVeeva
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