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If the UI is the lead institution or coordinating center, additional information must be provided in the HawkIRB application. Investigators should provide detailed information regarding the procedures requested in Section VII.A of the HawkIRB application including the methods used, communication channels, and the process for responding to serious problems occurring at the participating sites.
One responsibility of the lead institution is the ensure IRB approval for the project and any protocol modifications. The lead institution must also ensure that participating sites maintain continuing approval from their local IRB on an annual basis. The investigator should describe plans for tracking documentation of IRB approval for each participating site in Section VII.A of the HawkIRB application.