10929 REPORTS

10929.1 An investigator shall prepare and submit the following complete, accurate, and timely reports:

1. (a) 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 in no event later than ten (10) working days after the investigator first learns of the effect;
2. (b) An investigator shall report to the sponsor, within five (5) working days, a withdrawal of approval by the reviewing IRB of the investigator's part of an investigation;
3. (c) An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly;
4. (d) An investigator shall notify the sponsor and the reviewing IRB (see 21 C.F.R. § 56.108(a)(3) and (4)) of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than five (5) working days after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, the Department and IRB in accordance with § 10911.1 also is required;
5. (e) If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within five (5) working days after the use occurs;
6. (f) An investigator shall, within three (3) months after termination or completion of the investigation or the investigator's part of the investigation, submit a final report to the sponsor and the reviewing IRB; and
7. (g) An investigator shall, upon request by a reviewing IRB or the Department, provide accurate, complete, and current information about any aspect of the investigation.

10929.2 A sponsor shall prepare and submit the following complete, accurate, and timely reports:

(a) A sponsor who conducts an evaluation of an unanticipated adverse device effect under § 10918.2 shall report the results of such evaluation to the Department and to all reviewing IRBs and participating investigators within ten (10) working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as the Department requests;

(b) A sponsor shall notify the Department and all reviewing IRBs and participating investigators of any withdrawal of approval of an investigation or a part of an investigation by a reviewing IRB within five (5) working days after receipt of the withdrawal of approval;

(c) A sponsor shall notify all reviewing IRBs and participating investigators of any withdrawal of the Department approval of the investigation, and shall do so within five (5) working days after receipt of notice of the withdrawal of approval;

(d) A sponsor shall submit to the Department, at six (6) month intervals, a current list of the names and addresses of all investigators participating in the investigation. The sponsor shall submit the first of such lists six (6) months after the Department approval;

(e) At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a significant risk device, a sponsor shall also submit progress reports to the Department. A sponsor of a treatment IDE shall submit semi-annual progress reports to all reviewing IRBs and Department in accordance with § 10912.6 and annual reports in accordance with this section;

(f) A sponsor shall notify the Department and all reviewing IRBs of any request that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur within thirty (30) working days after the request is made and shall state why the request was made;

(g) In the case of a significant risk device, the sponsor shall notify the Department within thirty (30) working days of the completion or termination of the investigation and shall submit a final report to the Department and all reviewing the IRBs and participating investigators within six (6) months after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRBs within six (6) months after termination or completion;

(h) A sponsor shall submit to the Department a copy of any report by an investigator under § 10929.1(e) of use of a device without obtaining informed consent, within five (5) working days of receipt of notice of such use;

(i) 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 the Department a report of the IRB's determination within five (5) working days after the sponsor first learns of the IRB's determination; and

(j) A sponsor shall, upon request by a reviewing IRB or the Department, provide accurate, complete, and current information about any aspect of the investigation.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).