May 2004

During the life of a research project, certain events/occurrences need to be reported to the Institutional Review Board (IRB). The following is a reminder list for investigators:

Submit for IRB Approval

• Changes to study procedures/materials [protocols/grant proposals, subject population, consent instruments (including translated forms), recruitment procedures/materials, data collection instruments, adverse events and Investigator’s Brochure updates impacting risk/benefit ratio, etc.]
• Change in sponsor
• Changes in study status (closed to new subjects, data analysis only, concluded, withdrawal of project, etc.)
• Changes in personnel

Submit for IRB Review

• Adverse events (investigator-generated and sponsor-generated)
• Investigator’s Brochure updates (no change in risk/benefit ratio)
• Progress reports submitted to, or received from, sponsor
• Protocol deviations
• Site Authorizations

Reporting Requirement Reminder to Advisors/Investigators:

• All IRB-approved projects require continuing review at least annually (see project approval letter for review interval). For completed projects, where all data collection and analysis is finished, a concluding Periodic Review Form must be submitted to the IRB to officially conclude the project (see information at www.irb.arizona.edu/continuereview.html).