HSPP Ceded Review Checklists and Forms

The information below is for relying on an external IRB. There is information, guidance and checklists that must be used to customize sponsor template or lead site consent forms so that they include CHLA specific language.

Ceded Review Workflow

Relying on a Central IRB

• Instructions for Making a Submission to a Central IRB for Industry Sponsored Multi-Center Clinical Trials
• Template Document: Key Information Summary Section for Consent Forms
• Template Document: Disclosure of Financial Conflicts of Interest Statement for Consent Forms
• Reference Document: Advarra IRB Getting Started Guide
• Reference Document: WCG IRB Getting Started Guide
• Reference Document: Sterling IRB SilverLink Getting Started Guide
• Presentation: New Connexus Overview for WCG IRB
• Presentation: Initial Review Submissions to WCG IRB
• Presentation: Managing Studies Approved by WCG IRB
• Advarra IRB Resources
• WCG IRB Resources
• Sterling IRB Resources

Relying on Other External IRBs

• Reliance on Another IRB for Review and Oversight
• External IRB Consent Form Checklist
• NMDP IRB Consent Form Checklist
• NCI CIRB Boilerplate for Consent Forms
• CHLA Institutional Profile Information Sheet (CHLA Local Context)