External Reliance Studies - How & What to Submit

Reliance Agreement Tables

Commercial Agreements

COMMERCIAL IRB AGREEMENTHOW TO SUBMIT NEW STUDIES TO UCI IRBONLINE PORTALUCI GUIDANCESHORT FORMAMENDMENTSRENEWALSREPORTABLE EVENTS
TO IRB OF RECORDAND TO UCI
WCG IRBGuidance DocumentConnexusInfoDefer to UCI’s Use of Short Form (Policy 31)All changes

1. Personnel changes


2. Changes affecting HIPAA

Submit the Renewal Letter approved by the IRB of Record directly in KR Protocols

Reporting Requirements


Submit ‘Reportable Info Form’ via Connexus

AdvarraGuidance DocumentCIRBIInfo

Reporting Requirements


Guidelines

Other Agreements

OTHER AGREEMENTSHOW TO SUBMIT NEW STUDIES TO UCI IRBONLINE PORTALUCI GUIDANCEAMENDMENTSRENEWALS
UCI AS IRB OF RECORDUCI RELYINGTO IRB OF RECORDAND TO UCI
UC RelianceSMART IRBUCI Relying

UC Reliance Registry


Creating a new study


Relying PI Sign-Off

InfoAll Changes

1. Personnel changes


2. Changes affecting HIPAA

Submit the Renewal Letter approved by the IRB of Record directly in KR Protocols
National Cancer Institute (NCI) Central IRB (CIRB)N/AGeneral InfoCancer Therapy Evaluation Program (CTEP)Info
National Institutes of Health (NIH) single IRB (sIRB) ReviewN/AUCI RelyingN/AInfo
SMART IRBSMART IRBUCI RelyingOnline Reliance SystemInfo
CHOC-MHS-UCI (CMU)SMART IRBSMART IRBN/AInfo
StrokeNetN/AUCI RelyingN/AN/A
NeuroNEXTN/AUCI RelyingN/AN/A
Single Agreements (e.g., Chapman, Fountain Valley, Kaiser)

SMART IRB


IRB Authorization Agreement


Individual Investigator Agreement

UCI RelyingN/AInfo
Online PortalN/AN/ATrial Innovation Network (TINs)N/A
Online PortalN/AN/AIRB Reliance Exchange (IREx)N/A