Investigator Reports. The reports for which the Investigator has responsibility to generate are shown in the table below. The table also shows who should be the recipient of the report and timeframe for submitting it. While some of these reports will be developed by or with the assistance of Xxxxxxx, the final responsibility for them rest with the Investigator. Type of Report Prepared by Investigator For: Time Constraints of Notification Unanticipated Adverse Effect Sponsor As soon as possible but no later than 10 working days after knowledge of the event. Withdrawal of IRB Approval Sponsor Within 5 working days. Progress Report Sponsor / IRB Submitted at least annually. Protocol Deviations to protect the life or physical well-being of the subject in an emergency Sponsor / IRB Within 5 working days. Informed Consent Not Obtained prior to device use Sponsor / IRB Within 5 working days. Final Summary Report Sponsor / IRB Within 3 months of study completion/termination.
Investigator Reports. All study investigators shall prepare and submit the following complete, accurate, and timely reports.
Investigator Reports. Investigators are required to prepare and submit to the Sponsor the following complete, accurate, and timely reports on this investigation when are required. These reports, which are listed below, are required by 21 CFR §812.150; additional reports may be requested by the Sponsor: • The investigator will notify the Sponsor of a subject death occurring during the investigation, as soon as possible, preferably within 24 hours of learning of the subject’s death, but in no event later than 48 hours. The investigator will notify the reviewing IRB or EC of a subject death as specified by the IRB or EC. • The investigator will notify the Sponsor of any unanticipated adverse device effects within 48 hours after learning of the effect. The investigator will notify its reviewing IRB or EC of any unanticipated adverse device effects, as soon as possible, but no later than 10 working days after learning of the effect. • The investigator will notify the Sponsor of the withdrawal of IRB or EC approval, as soon as possible, but no later than five working days after learning of the withdrawal. • The investigator will provide current progress reports to the Sponsor and reviewing IRB or EC at regular intervals and at least on an annual basis. • The investigator will notify the Sponsor and reviewing IRB or EC of any deviation from the investigational plan to protect the life and physical well-being of a subject in an emergency, as soon as possible, but no later than five working days after the emergency occurred. • The investigator will notify the Sponsor and reviewing IRB or EC that an informed consent was not obtained from a subject, as soon as possible, but no later than five working days after such an occurrence. • The investigator will provide a final summary report to the Sponsor and reviewing IRB or EC within three months after termination or completion of the study. • The investigator will provide any other information upon the request of an IRB or EC, FDA, or the Sponsor.
