Common use of External Reporting Clause in Contracts

External Reporting. With respect to Research under Ceded Review, a Relying Institution will notify the Reviewing IRB/Reviewing IRB Institution in advance if the Relying Institution determines under applicable federal human subjects protection regulations or under the terms of the Relying Institution’s Assurance that a Report is required. With respect to Research that is the subject of an Exemption Determination, such notification will be limited to a determination that a Report is required of serious and/or continuing noncompliance with the Federal Policy or with the terms of the Exemption Determination that disqualifies the Research from the relevant exemption. A Relying Institution will promptly provide any comments on any draft Report that will be made by the Reviewing IRB/Reviewing IRB Institution pursuant to Section 5.13.1 hereof; 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. If the Reviewing IRB/Reviewing IRB Institution and a Relying Institution will make a joint Report pursuant to Section 5.13.2 hereof, they will work collaboratively to prepare and timely submit the Report and will not make independent Reports unless they cannot ultimately or timely agree on the content of the Report. If the Relying Institution will make the Report pursuant to Section 5.13.2 hereof, the Relying Institution will promptly prepare the draft Report and will provide the Reviewing IRB/Reviewing IRB Institution with the opportunity (no fewer than five (5) business days, whenever possible and consistent with any applicable federal regulations or requirements) to review and comment on the draft Report, after which time the Relying Institution may finalize and send the Report to external recipients (such final Report will also be copied to the Reviewing IRB/Reviewing IRB Institution). Regardless how Reports are handled, the Relying Institution will make and be solely responsible for any and all other reports or notifications in accordance with Section 5.13.3 hereof.

External Reporting. With respect to Research under Ceded Review, a Relying Institution will notify the Reviewing IRB/Reviewing IRB Institution in advance if the Relying Institution determines under applicable federal human subjects protection regulations or under the terms of the Relying Institution’s Assurance that a Report is required. With respect to Research that is the subject of an Exemption Determination, such notification will be limited to a determination that a Report is required of serious and/or continuing noncompliance with the Federal Policy or with the terms of the Exemption Determination that disqualifies the Research from the relevant exemption. A Relying Institution will promptly provide any comments on any draft Report that will be made by the Reviewing IRB/Reviewing IRB Institution pursuant to Section 5.13.1 hereof; 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. If the Reviewing IRB/Reviewing IRB Institution and a Relying Institution will make a joint Report pursuant to Section 5.13.2 hereof, they will work collaboratively to prepare and timely submit the Report and will not make independent Reports unless they cannot ultimately or timely agree on the content of the Report. If the Relying Institution will make the Report pursuant to Section 5.13.2 hereof, the Relying Institution will promptly prepare the draft Report and will provide the Reviewing IRB/Reviewing IRB Institution with the opportunity (no fewer than five (5) business days, whenever possible and consistent with any applicable federal regulations or requirementspossible) to review and comment on the draft Report, after which time the Relying Institution may finalize and send the Report to external recipients (such final Report will also be copied to the Reviewing IRB/Reviewing IRB Institution). Regardless how Reports are handled, the Relying Institution will make and be solely responsible for any and all other reports or notifications in accordance with Section 5.13.3 hereof.