Provision Language
Attachment 4: Reporting Requirements
Clinical Reporting Requirements
The section below includes Clinical reporting requirements if applicable. All reports should be submitted to the CARB-X Chief of R&D, CARB-X Alliance Lead, and CARB-X Research Compliance Lead (see attachment 3A), unless indicated otherwise below.
Clinical Studies Status Updates: Portfolio Company shall provide the CARB-X Chief of Research and Development with a status update of clinical studies that are actively enrolling patients to include by study site: cumulative enrollment; new enrollments; screen failures; patients dropped from study; AE and SAEs; activation or inactivation of study sites; investigator appointments or changes; and status of IRB/IEC review/approval/renewal. Status update shall also include a report of all changes in the status of any ongoing clinical study protocols. Portfolio Company shall provide such status updates on a monthly basis.
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Required Time Sensitive Notifications on FDA safety reports of serious adverse events: Under an IND or IDE, Portfolio Company must provide FDA safety reports of serious adverse events. Portfolio Company must submit copies of such FDA safety reports to the CARB-X Chief of Research and Development, as detailed below. a. Expedited safety report of unexpected or life-threatening experience or death: A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) calendar days after the IND sponsor’s receipt of the information, must be submitted to CARB-X and BARDA within 24 hours of FDA notification. Under an IND or IDE, Portfolio Company must provide FDA safety reports of serious adverse events. Portfolio Company must submit copies of such FDA safety reports to the CARB-X Chief of Research and Development, as detailed below.
a. Expedited safety report of unexpected or life-threatening experience or death: A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) calendar days after the IND sponsor’s receipt of the information, must be submitted to CARB-X and BARDA within 24 hours of FDA notification.
b. Expedited safety reports of serious and unexpected adverse experience: A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to CARB-X and BARDA within 24 hours of FDA notification.
c. IDE reports of unanticipated adverse device effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to CARB-X and BARDA within 24 hours of FDA notification.
d. Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to CARB-X and BARDA.
FDA or EMA Audits
In the event of an FDA or EMA inspection which occurs that relates to products under this Agreement, or for any other FDA or EMA inspection that has the reasonable potential to impact the performance of this Agreement, Portfolio Company shall provide CARB-X with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) (or the corresponding forms from the EMA). Portfolio Company shall provide CARB-X with copies of the plan for addressing areas of non-conformance to FDA or EMA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plan’s execution and a copy of all final responses to the FDA or EMA.
a. Portfolio Company shall notify CARB-X within 5 business days of a scheduled FDA or EMA audit or within 12 hours of an ad hoc site visit/audit if the FDA or EMA does not provide advanced notice.
b. Portfolio Company shall provide copies of any FDA or EMA audit report received from sub-recipients that occur as a result of this agreement or for products funded hereunder within three (3) business days of receiving correspondence from the FDA or EMA.
c. Within five (5) business days of audit report, Portfolio Company shall provide CARB-X with a plan for addressing areas of nonconformance, if any are identified.
d. For the purposes of this Attachment, “EMA” includes all constituent national drug regulatory authorities.
Regulatory Submissions and Correspondence
a. Draft Clinical Study Report: submit to Managing Entity at least 20 business days prior to the anticipated FDA or other regulatory authority submission date, for submission to BARDA by Managing Entity. If corrective action is recommended, Portfolio Company will use reasonable efforts to address, in writing or by corrective action, all concerns raised by BARDA prior to FDA or other regulatory authority submission.
b. Draft Regulatory Meeting Briefing Packets: submit to Managing Entity at least 15 business days prior to anticipated submission to the regulatory authority, for submission to BARDA by Managing Entity. If corrective action is recommended, Portfolio Company will address in writing its considerations of all concerns raised by BARDA. Portfolio Company will consider revising documents to address BARDA’s concerns and/or recommendations prior to submission to regulatory authorities.
c. Final FDA or other regulatory submissions: submit to Managing Entity concurrently or no later than 2 business days after submission to FDA or other regulatory authority, for submission to BARDA by Managing Entity.
d. Managing Entity may request that Portfolio Company provide any regulatory correspondence (FDA, EMA, etc.) for products supported under this Agreement.
Non-Routine Reports and Notifications
The section below includes non-routine (Ad hoc) reporting requirements. These reports are event driven and are due contingent upon such events occurring. All reports should be submitted to the CARB-X Chief of R&D and Alliance Lead (see Attachment 3A). Additional report recipients are as indicated below.
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QA Audits and Reports
Managing Entity reserves the right to participate in QA audits at the Portfolio Company. Upon completion of the audit/site visit the Portfolio Company shall provide a report capturing the findings, results and next steps in proceeding. If action is requested of the Portfolio Company, detailed concerns for addressing areas of non-conformance to FDA or EMA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to Managing Entity. The Portfolio Company shall provide responses from the site to address these concerns and plans for corrective action execution.