Reliance System

Introduction

• Logging in to the Reliance System
• Overview of the reliance request and decision-making processes
• Introduction to the Reliance System
• Privacy Policy and Terms of Use
• Documenting SMART IRB reliance arrangements made prior to launch of the Reliance System
• Participating Institution contact information

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Registering for an account

• Who can use the SMART IRB Reliance System?
• Create an account to submit a request for reliance
• Create an account as the Point of Contact (POC) for an institution

System Roles

• Adding Users to a Request
• Understanding System roles
• Submitter role
• Reliance POC role
• Reliance POC Backup role
• Designating multiple Reliance POCs

Submitting a request for reliance

• Information needed to submit a request for reliance
• Can the Reliance Point of Contact create and submit a reliance request?
• Making changes to a Reliance Request
• Participating Institution not listed in the Reliance System

Reliance Determination Process

• Issuing the Site Specific Determination Letter
• Indicating willingness to rely on the Reviewing IRB
• Identifying a Reviewing IRB
• Local Considerations
• HIPAA privacy review
• Communications from the Reviewing IRB

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Adding new sites to a request

• Multiple Amendments
• Adding additional sites to a request
• Why can't I amend my request with additional sites?

Post-Determination Processes

• Next steps for a study after a reliance determination
• Integration with local IRB applications

User Management

• The User Management Dashboard