Reporting Flashcards
812: Withdrawal of FDA Approval: A sponsor shall notify all reviewing IRB’s and participating investigators of any withdrawal of FDA approval of the investigation within
5 working days after receipt of notice of the withdrawal of approval
812: Significant Risk Device Determination: If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB’s determination within
5 working days
812: Informed consent: If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within
5 working days after use
812: Final Report: An investigator shall submit a final report to the sponsor and the reviewing IRB within
3 months after termination or completion of the investigation or the investigator’s part of the investigation
812: Unanticipated Adverse Device Effects: A sponsor who conducts an evaluation of an unanticipated adverse device effect under §812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB’s and participating investigators within
10 working days
812: Unanticipated Adverse Device Effect : An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation
As soon as possible but no later than 10 business days after investigators learn of the effects
812: Recall and Device Disposition: A sponsor shall notify FDA and all reviewing IRB’s of any request that an investigator return, repair, or otherwise dispose of any units of a device within
30 working days
812: Deviation from Investigational Plans: An investigator shall notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency no later than
5 working days
312: IND Safety Reports: Sponsor must report to FDA and all investigators in an IND safety report of potential serious risks no later than
As soon as possible but no later than 15 calendar days
312: The sponsor must also notify FDA of any unexpected fatal or life-threatening suspected adverse reaction
As soon as possible but no later than 7 calendar days
312: Annual Report: A sponsor submits a brief report of the progress of the investigation within
60 days of the anniversary date that the IND went into effect
312: An IND goes into effect…
30 days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold
ICH E2A : Fatal or Life-Threatening Unexpected ADRs
ASAP, no later than 7 calendar days, full report within 8 calendar days
ICH E2A : All Other Serious, Unexpected ADRs
ASAP, no later than 15 calendar days
Investigators: All SAEs should be reported…
immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator’s Brochure) identifies as not needing immediate reporting.
