IRB Navigation & Pre-Review Service for Investigators

• Pre-Review of IRB Submissions: Pre-review of documents includes a comprehensive review of all investigator draft documents to assure they are completed correctly and that the information presented is consistent among the study documents. In addition, the protocol review includes analysis of recruitment strategies and procedures, data collection, risks, safety precautions, and protection of confidentiality. This review is done to assist investigators in presenting complete, accurate, and thorough applications to the IRB. Assistance for full board, exempt, and expedited submissions is provided. A Pre-Review typically results in a significant reduction in submission errors to the IRB.
• General information or brief consultation regarding resources and services to support clinical and translational research
• Education and training in meeting regulatory requirements for clinical research

The IRB Navigator is a research service offered to investigators who require Institutional Review Board (IRB) approval for their study. Investigators can enjoy personalized assistance with the IRB process, from guidance with the e-Bridge application through help with amendments and reportable events after IRB approval.

Benefits

• The IRB Navigator acts as a liaison between the investigator and the IRB Coordinator to assist in clarifying areas requiring further explanation prior to the application going to
• the IRB committee, helping to assure the appropriate information is presented to the reviewers and committee chair.
• Tracks and troubleshoots delays as the protocol moves through the review process to promote a smooth,  successful outcome.
• After a study is approved, the IRB Navigator may assist with amendments, continuing progress reports and reportable events.