FDA starts effort to respond to I.G. report on dwindling BiMo audits; Part 11 still a concern.(I.G. Report)(Food and Drug Admini

BOSTON FDA's Human Potential Clinical Steering Committee has recently issued reports and guidance documents in direct response to the unfavorable report issued in October by the HHS Office of the Inspector General (I.G.), which has triggered a congressional inquiry.

This was the first topic addressed by a number of representatives of FDA gathered in an informal conversational setting at the annual Human Research Protection Programs conference held Dec. 3-6, sponsored by Public Responsibility in Medicine and Research (PRIM&R).

The I.G. report, entitled: "The Food and Drug Administration's Oversight of Clinical Trials," found that FDA inspects only 1% of trial sites through its Bioresearch Monitoring (BiMo) program, and that 48% of BiMo inspection records lacked the Centers' final classifications (See October issue, page 1).

The panel began by bringing up the subject of the Human Potential Clinical Steering Committee, some of whose recent reports and guidances were in direct response to the I.G. report and congressional inquiry. "They were right," said Joanne Less, Ph.D., Director, Good Clinical Practice Program, Center for Devices. "We're working now to respond and make improvements." Among the issues were the absence of any single interrelated database and a lack of informed consent guidances.

FDA plans to consolidate some of its informational sheets as a result of the changes made, though when a participant asked when this would happen, Less laughed. "'Soon' in the FDA world," she acknowledged, "means several months."

Another group of questions had to do with the scope of applicability of certain guidance documents - specifically concerning the agency's electronic records/signature rule (21 CFR Part 11) and how it applies to electronic medical records.

Attendees asked some of these questions Are the records maintained in a computerized system subject to 21 CFR 11? Does it apply to a computerized system used only for administrative functions?

FDAers responded that the answers partly depend on underlying predicate regulations and internal policies. The regulation doesn't stand alone - record and signature requirements flow from current good practice guidances that should be in place already for paper data-keeping.

A company's internal policies, the behaviors of system endusers, and other factors may also influence both the scope and the applicability of Part 11. The panel further pointed to the May 2007 guidance that issues FDA's consensus on what to do with Part 11, particularly in the area of access to and security around records.

"What measures do you have in place for paper?" asked Robert Nelson, M.D., Associate Professor of Social Medicine and Pediatrics, Director, Office of Human Research Ethics, University of North Carolina, Chapel Hill. "Electronic measures should be similar. We're not asking you to do any more than you're already doing now."

"There has been this predicate regulation, which is really an emerging field," said Leslie Ball, M.D., Branch Chief, Good Clinical Practice Branch II, Center for Drugs Division of Scientific Investigations. "We're so used to using judgment and discretion, and that's not enough anymore - we really need more definition about the scope of the regulation. In general, though, it's just good data practice."

She pointed to a webinar being offered on that particular day and accessible in the future at the site that will give some clarification to the questions and more fully explain the recent guidance.

A general recommendation was reiterated: People should determine in advance whether they plan to rely on the electronic record or on the paper record to perform regulated activities, and stay consistent throughout the process. The guidance further states that "FDA normally does not intend to object if you decide to archive required records in electronic format to non-electronic media such as microfilm, microfiche, and paper, or to a standard electronic file format, such as PDF."

The panel further noted that hospitals are not part of the 21 CFR Part 11 issues requirements.

Other panel members included David LePay, M.D., Ph.D., Senior Adviser for Clinical Science, Science/Health Coordination and International Programs, Office of the Commissioner; Diane Maloney, Associate Director for Policy at CDER; and Michael Marcarelli, Ph.D., Special Assistant to the Director, Office of Compliance, CDRH.

By Jeannette Cezanne New England Correspondent

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