External Reliance Studies - How & What to Submit

Reliance Agreement Tables

COMMERCIAL IRB AGREEMENT	HOW TO SUBMIT NEW STUDIES TO UCI IRB	ONLINE PORTAL	UCI GUIDANCE	SHORT FORM	AMENDMENTS		RENEWALS	REPORTABLE EVENTS
					TO IRB OF RECORD	AND TO UCI
WCG IRB	Guidance Document	Connexus	Info	Defer 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
Advarra	Guidance Document	CIRBI	Info					Reporting Requirements Guidelines

OTHER AGREEMENTS	HOW TO SUBMIT NEW STUDIES TO UCI IRB		ONLINE PORTAL	UCI GUIDANCE	AMENDMENTS		RENEWALS
OTHER AGREEMENTS	UCI AS IRB OF RECORD	UCI RELYING	ONLINE PORTAL	UCI GUIDANCE	TO IRB OF RECORD	AND TO UCI	RENEWALS
UC Reliance	SMART IRB	UCI Relying	UC Reliance Registry Creating a new study Relying PI Sign-Off	Info	All 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/A	General Info	Cancer Therapy Evaluation Program (CTEP)	Info
National Institutes of Health (NIH) single IRB (sIRB) Review	N/A	UCI Relying	N/A	Info
SMART IRB	SMART IRB	UCI Relying	Online Reliance System	Info
CHOC-MHS-UCI (CMU)	SMART IRB	SMART IRB	N/A	Info
StrokeNet	N/A	UCI Relying	N/A	N/A
NeuroNEXT	N/A	UCI Relying	N/A	N/A
Single Agreements (e.g., Chapman, Fountain Valley, Kaiser)	SMART IRB IRB Authorization Agreement Individual Investigator Agreement	UCI Relying	N/A	Info
Online Portal	N/A	N/A	Trial Innovation Network (TINs)	N/A
Online Portal	N/A	N/A	IRB Reliance Exchange (IREx)	N/A