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FDA Part 11 Enforcement Resumes in Clinical Trial Inspections:Does Industry Have To Ride The Audit Trail Again?11 April 2005. ROCKVILLE, MD - Although promising in the August 2003 final guidance on Part 11 to exercise "enforcement discretion", the Agency has apparently resumed enforcement of Part 11 requirements resulting from Clinical Trial Inspections with a Warning Letter issued to a New York physician concerning clinical trial regulation violations. Following the issuance of the Final Guidance, FDA indicated that it had started to re-examine part 11 as it applied to all FDA-regulated industries, and would likely amend the Part 11 regulation sometime in 2005. To date, however, there has been no word out of FDA regarding how far such a re-examination has progressed, and how close or far they and we are to a revision to the regulation. The Warning Letter, issued to Dr. Kenneth J. Rosenthal of Great Neck, NY, largely focuses on Part 812 (Investigational Device Exemption) regulation violations, and on violations from a previous inspection. However, the finale to the letter addresses Dr. Rosenthal's electronic medical record (EMR) system, allegedly used to "maintain medical and other clinical data for ...study subjects." The Warning Letter goes on to state that such as system used to maintain study records must meet Part 11 requirements, and calls for proof of the following Part 11 requirements to be submitted: "documentation of the validation of your EMR system
to ensure accuracy, reliability, and the ability to detect invalid or altered
records; documentation of the ability to
generate accurate and complete copies of records suitable for inspection,
review, and copying by the agency; and documentation
of a secure, computer-generated, time-stamped audit trail that can independently
record the date and time of operator entries and actions that create, modify, or
delete electronic records, and to verify that record changes do not obscure
previously recorded What is deeply troubling is the last submission request, concerning the secure, computer-generated, time-stamped audit trail, which clearly was one of four Part 11 requirements in the August 2003 Final Guidance which FDA indicated they were backing off from. Therefore, the question is: how valid is the Final Guidance now? or put another way: is this Warning Letter the "first shot fired across the regulated industries' bow" since the Final Guidance indicating that the Agency intends to bring the audit trail requirement back when the regulation is revised? To review or obtain your own copy of the Warning Letter, click here. To review or obtain your own copy of the August 2003 Final Guidance on Part 11, click here. To review or obtain the September 2004 draft Guidance on Computerized Systems Used in Clinical Trials, click here. Or, for a more systematic approach, to speak with a CRO Group Part 11 consultant on the relevancy of the Part 11 Final Guidance, the draft Computerized Clinical Trial Systems Guidance, as well as the questions or tests to determine if your electronic system will fall inside or outside the newly defined scope of the regulation, click here. The CRO Group has a well-established program for companies to assess their compliance with the Final Guidance as well as the draft Computerised Clinical Trial Systems Guidance so as to identify potential areas of noncompliance before the next inspection. The CRO Group has a series of services specifically designed to address compliance with the Final Guidance on Part 11, such as our Initial Gap Analysis Audit, and our Comprehensive Remediation services. You can stay ahead of these changes in the USA, EU, Canada, and virtually everywhere on the planet by subscribing to StdsRadar. For a no obligation quote, contact us at stdsradar@crogroup.com.
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