Center for Spinal Disorders, Thornton, CO, July 3 (Rockville, MD).(Warning Letters)

The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in June 2007. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W, etc.). Copies of responses to the letter, along with any 483s and EIRs, are available from RECORD-RETRIEVE: (703) 779-8777, or SERVICE@FDAINFO.COM.

The firm's activities and procedures during a clinical study failed to comply with applicable FDA regulations. Specifically, the company failed to obtain informed consent requirements by having subjects screened before signing the informed consent form (ICF); also subjects signed a wrong consent form.

The company's response stated that patients completed self-assessment forms during routine office visits prior to signing the ICF and that no evaluations were shared with the study sponsor until the patient signed the appropriate form.

Also, the response said there was an administrative error as to why the wrong form was used. However, the response failed to submit the correct actions that will be taken to prevent this in further studies.

The letter further stated that the company failed to ensure that the investigation was conducted in accordance with the signed agreement, the investigational plan, and applicable FDA regulations.

For example, two subjects enrolled in the study did not meet the study's inclusion criteria; the investigator failed to report adverse events (AE) for eleven of the subjects within the ten working days required by the protocol; and the study protocol required the subjects to be evaluated at prescribed visits during the course of the study, however this was not followed.

The company also failed to prepare and submit a complete and accurate report of an unanticipated adverse device effect within ten working days after first learning of the effect, to the sponsor and the reviewing IRB. Specifically, AEs for seven subjects were not reported within the required timeframes and some were not reported at all.

The company's response stated that it "routinely conducts retrospective review to ensure that all AE's have been captured and reported as required; and, that none of the AEs during the reviews involved the investigational device."

The company further stated that all study personnel have been retrained on the IRB and sponsor reporting requirements, however it failed to provide details on the specific training, the warning letter noted. Doc. 14205W

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