You are here

Home » Pre-Submission

Submission Requirements

Submission Type CITI Training Protocol1 Faculty Advisor Review2 Supporting Documents3
Initial Application Exempt Y Y Y Y
  Expedited/Full Y Y Y Y
Continuing Review Exempt Renewal no longer required.
  Expedited/Full Y Y Y S
Amendment Exempt Y Y Y S
  Expedited/Full Y Y Y S
Response Exempt Y S S S
  Expedited/Full Y S S S
Study Closure Exempt N n/a n/a n/a
  Expedited/Full N n/a n/a n/a
Deviation ALL TYPES Y n/a Y S
Reportable Event ALL TYPES Y n/a Y S

 

Legend: Y = Yes, required N = No, not required S = Somtimes required n/a = Not applicable

Helpful Tips

  1. Protocol Document - Click here to download a the latest version of the protocol document template.Other useful documents are located on the Forms & Templates tab.
     
  2. Faculty Advisor Review is required for submissions created by student researchers. Both undergraduate and graduate level students must route their submission to a faculty advisor for approval before sending it to the IRB office.
     
  3. Supporting Documents - To avoid delays in the review process, include all documents to be used in the study. In order for our reviewers to adequately assess the risk a participant may be exposed to, we need to have all the information. Examples of such documents vary widely by study, but may include Informed Consents, Flyers, Surveys, Interview Questions, Phone Scripts, Recruitment Emails, etc. All documents must be submitted in final version before approval can be provided. For studies operating under IND(s), the most recent Annual Report to the FDA must be included in the Continuing review submission.