What documents are required for submission to the AIRB? 

Required Documents for Review by the AIRB: 

• Final signed protocol with unique protocol #, protocol title and name of principal investigator on the cover page 

• Principal Investigator’s current CV 

• Informed Consent(s) / Informed Assent(s) (for all studies involving minors) 

Additional Supporting Documents (if applicable): 

• Product description

• Formula (if not yet FDA approved yet) 

• Safety data – summaries from previous preclinical or clinical studies  

• Recruitment Materials 

• Data Collection & Screening Materials 

• Instructions for Use (IFU) 

• Device manuals 

• Notification of any special conditions of the local population (ie: prison populations, special needs subjects, language barriers, etc.)