Common use of Reporting; Notification of Communications with Regulatory Agencies Clause in Contracts

Reporting; Notification of Communications with Regulatory Agencies. Promptly provide any comments on any draft report to external parties that will be made by the Reviewing IRB/Reviewing IRB Institution pursuant to Section 5.13.1 through 5.13.3 hereof. If the Reviewing IRB/Reviewing IRB Institution requests that the Relying Institution make the report, the Relying Institution will promptly prepare the draft report and provide the Reviewing IRB/Reviewing IRB Institution with the opportunity (no fewer than five (5) business days, whenever possible) to review and comment on the draft report, after which time the Relying Institution may finalize and send the report to external recipients. If the Relying Institution elects to make its own additional report, it will provide a copy of such report to the Reviewing IRB/Reviewing IRB Institution. The Relying Institution will also promptly notify the Reviewing IRB/Reviewing IRB Institution of communications received by the Relying Institution or between the Relying Institution and FDA, OHRP, and/or other regulatory agencies, regarding unanticipated problems, noncompliance, or other compliance concerns regarding the Research, and will require the Overall PI and Site Investigator(s) to do the same with respect to such communications between the Overall PI or Site Investigator(s) and such agencies.