Clinical investigator re-inspection nets clean inspection report.

A re-inspection of clinical investigator Timothy Chuter, M.D., San Francisco, CA, resulted in a clean report with no deviations noted.

Investigator Marie Kinkade from the Irvine, CA, District Office conducted the investigation. The EIR stated that the doctor conducts clinical studies of endovascular stent-graft implants for the treatment of an undisclosed condition.

The previous investigation noted numerous deficiencies that required Chuter to make improvements. Changes noted during this audit included:

* Draft data collection SOP, draft informed consent SOP--both SOPs for data collection and informed consent were examined and found to be satisfactory.

* Hire a study monitor/supervisor--This was done on Oct. 11, 2004. The new hire told the FDAer that before she was appointed, "the Division of Vascular Surgery clinical studies did not have appropriate regulatory compliance regarding record keeping and data management. She said that staff had not been trained in regulatory compliance issues that not all ADEs were reported and that consent forms were not organized."

* Write and implement monitoring procedures monitoring procedures were found to have been written "in a cursory form." In the future, procedures for monitoring will be expanded in much more detail, the establishment stated.

* Establish enrollment book--The new study monitor provided the FDAer with enrollment names of the subjects on one study IDE. "I viewed the consent forms, witness signatures, dates and did a rough check for missing informed consent data," the FDAer stated. They were found to be adequate.

* Establish adverse event log--"they now are maintaining a separate adverse event binder, with ADE filed under a separate tab. An AE summary log is kept as part of the binder, as well as a copy of any report to FDA."

Regarding the informed consent log, the EIR stated that the research staff after the first audit tried to locate all missing consents, and subjects from three studies were missing consent forms. After the inspection, the staff was able to find some subjects to resign their consents. Some however were not able to be located.

Regarding the adverse event log, the new monitor noted that since they had fired the database manager, "she personally went through every chart, comparing it to the newly created enrollment log. She made sure she could account for every clinical patient contained within the list. Her work covered two or three years of filing found in boxes," the EIR stated.

Timothy Chuter, M.D., San Francisco, CA, 12/14-16/05, Doc. 110002M, $4 plus retrieval.