Daniel Cohen, M.D., Fenway Community Health, Boston, MA, May 16, (CBER).

FDA inspector Karen McNabb-Noon conducted the audit Jan. 20-28 to determine if Cohen's activities as a clinical investigator, involving unnamed investigational devices, complied with applicable FDA regulations.

Several deviations were cited that pertained to the rights, safety or welfare of human subjects.

FDA said Cohen failed to ensure that the investigation was conducted according to the investigational plan, the signed agreement and applicable FDA regulations. For example, Cohen failed to document that subjects enrolled in the study met the health status enrollment criteria. Also, of the 111 subjects enrolled, there were no on-site records documenting medical history for 15 of them.

Furthermore, Cohen failed to maintain accurate and complete records of each subject's case history and failed to document the receipt, use and disposition of devices.

FDA said Cohen also admitted proficiency testing was not done prior to the study opening for enrollment; but in a rebuttal, Cohen stated that for future studies he "will explicitly document study-specific training with signed and dated training logs." The agency found this inadequate, adding that Cohen must "also ensure that all required training and proficiency testing for all personnel occur."

Additionally, Cohen was cited for failure to document temperatures showing proper storage of the investigational device as required by the protocol.

Lastly, FDA noted that Cohen violated protocol by failing to ship samples on the day they were obtained and it was determined that, at times, delays in shipping ranged from one to seven days.

The agency acknowledged receipt of Cohen's Feb. 14 response letter and advised that if the proposed corrections become implemented, the corrective actions would be adequate. BiMo, E-M; Doc. 13499W