Maier slapped with 3-citation 483 for case history flaws, not reporting AEs.(Clinical investigators)

William Maier, M.D., Eugene, OR, received a 483 with three citations because he failed to maintain accurate case histories. Also, the researcher did not report to the sponsor adverse events (AEs) that may have been caused by the investigational drug, FDA records show.

Investigator Astrida Mattson from the Bothell, WA, District Office conducted the investigation for the agency.

The 483 stated that a review of the site's records revealed that some subjects reported allergies to various drugs but the CRFs did not contain this information.

The EIR added that the clinical trial enrolled 13 subjects who claimed to be allergic to undisclosed drugs or substances that could be exclusion criteria.

"The sponsor did not that there was a substantial number of questions for clinical investigators regarding the enrollment of subjects who are allergic and/or sensitive to [undisclosed] and addressed the issue in a newsletter. [It stated] that subjects could enroll if the researcher could ensure that the subject's side-effects were not an allergic reaction and that the reported sensitivity was circumstantial and did not have clinical significance and would not adversely affect the safety of the subject."

Regarding AEs, the report stated that two days after the randomization visit, one subject "reported experiencing nausea, vomiting, dizziness, sleepiness and headache ... [but] nausea was the only adverse event reported on the CRF for this time period."

The EIR stated that the FDAer performed a review of 26 subject records that included subject eligibility to participate in the study, which is when the non-reporting of AEs was discovered.

The report noted: "Each subject record contained information on the condition of the subject at the time of entry into the study, records of exposure to the test article, information on the condition of the subject throughout the study and signature/initials of the person obtaining information from the subject."

The EIR also noted that other unreported AEs included myocardial infarction, flu and constipation.

Next, FDA documents stated that the investigation was not conducted in accordance with the signed statement of the investigator. The protocol was not followed in that before and during study participation, one subject was taking an undisclosed drug that was disallowed by the protocol.

The EIR also noted that subject records "were well organized, bound together with metal fasteners, complete and legible."

In the study, the data was entered directly onto the CRF by the investigator, study coordinator and subject. "The original copy remained at the site and a carbonless paper-type copy was retrieved by the monitor," the document stated. William Maier, M.D., Eugene, OR, 10/10-20/06, Doc. 115381, $14 plus retrieval.

William Maier, M.D., Eugene, OR, Bothell, WA, District

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