When a protocol is pre-reviewed, the investigator will receive correspondence detailing requests for revisions, clarification, or additional information. When the modifications are made and submitted to the IRB, they are reviewed by administrative staff and the IRB Chair, Vice Chair or member designee.
The investigator has 90 days to respond to the revisions requested. If the investigator does not respond in 90 days, the application is withdrawn and returned to the investigator. If the investigator wishes to conduct a study that has been withdrawn, the investigator must submit a new application, incorporating comments from the prior IRB review.
Please note that this procedure is in effect for ALL studies- regardless of review type.