Required Time-Sensitive Notification Clause Samples
Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's representative (COR) as follows:
1. 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 days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative within 24 hours of FDA notification.
2. Expedited safety reports of serious and unexpected adverse experiences – 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 the Contracting Officer’s Representative within 24 hours of FDA notification.
3. IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification.
4. Expedited safety reports – shall be sent to the COR concurrently with the report to FDA.
5. Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the COR annually. In case of problems or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.
Required Time-Sensitive Notification. Under the contract, the Contractor must submit to the Contracting Officer’s representative (COR) as follows:
1. 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 days after the IND sponsor’s receipt of the information, must be submitted within 24 hours of knowledge of the event by the Contractor.
Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s representative (COR) as follows:
Required Time-Sensitive Notification. Under an IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s Representative (COR) as follows:
a. IDE reports of unanticipated adverse device effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the COR within [***] of FDA notification.
b. Expedited safety reports: Sent to the COR concurrently with the report to FDA.
c. Other adverse events documented during the course of the trial should be included in the annual IDE report and reported to BARDA annually. In case of problems or issues, the Contracting Officer’s Representative will contact the Contractor within [***] by email or fax, followed within [***] by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.
d. Safety reporting for research not performed under an IDE. Final decisions regarding ongoing safety reporting requirements for research not performed under an IDE must be made jointly by the COR and the Contractor.