Regulations stipulate that a study may be IRB approved for, at most, a period of one year. The IRB will determine, at the time of initial approval, the period of approval, and the investigator will be notified in writing of the expiration date. When a study is nearing its expiration, the IRB office will send a notification electronically to the investigator.
If the study was submitted through the Clinical Research Center:
The research personnel will complete the appropriate application for renewal or closure. Then, the investigator will receive an e-mail notification that his/her signature is required to complete the submission. The investigator will need to log in to iMedRIS, and sign off electronically.
If the study was submitted to the IRB directly:
The investigator will need to log into iMedRIS click on “Research Assistant” and then on “My Projects”, and select the appropriate study. Once opened, a submission form tab will appear and the investigator can select the “Continuing Review Submission Form” or the “Study Closure Form”. The form needs to be completed, signed electronically and then submitted to the IRB.
Applications need to be submitted to the IRB office at least two weeks prior to the meeting date.