Prospective Clinical Trials Involving the Consent Process: IRB Decisions/IRBNet Submission Forms

IRB Letter of (approval, deferment and modifications required, etc.) should be on top of each set of submission package forms.

Each package should include the IRBNet forms, such as the

Initial Application, Continuing Review, Amendments, Adverse Events, Protocol Deviations, Close out information, Investigator responses to IRB notifications.  Each package will have its own IRBNet submission forms.  Package submission forms should be kept in this section but separated from each other.

Example: 

• package 1  core data form
• package 2  IRB letter of  modifications required, core data form, basic application 1 basic application 2, supplement L, supplement E,  COI for each study team member.
• package 3  IRB letter of approval, revised core data form, basic application 2.
• package 4  IRB letter of approval, continuing review form, COI for each team member, updated CITI certificates as applicable.

Packages should be stored in reverse chronological order with the most current document first.  

If you have missing documents not available on IRBNet contact the IRB administrative office at 4-4356.

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