Clinical Research trials Auditing forms
Raymond B. Weiss, MD, FACP, is a clinical professor at Georgetown University Medical School, Washington, DC, and a practicing medical oncologist with extensive experience in monitoring cancer clinical trials. Both Dr. Weiss and Susan S. Tuttle, RN, CCRP, are with the Cancer and Leukemia Group B (CALGB) Data Audit Committee, at the CALGB Central Office, University of Chicago, Chicago, Illinois.
In the mid-1950s, the National Cancer Institute (NCI; Bethesda, Maryland) began funding the Cooperative Group Program. Throughout the next 25 years, there was no on-site verification of protocol compliance and validation of the data submitted by participating members of these cooperative groups. In contrast, the US Food and Drug Administration (FDA; Washington, DC) required that pharmaceutical companies perform on-site validation of the clinical trial data involving testing of investigational new drugs. In 1979, it was discovered that scientific fraud had occurred at one institution that was a prominent member of a major NCI-funded cooperative group. As a result of that event, in 1981 the NCI implemented a requirement that all entities funded by the NCI must have a system in place for on-site auditing of clinical trial data and protocol compliance. Verification of administrative requirements, such as oversight by an institutional review board (IRB) and documentation of written informed consent, was also implemented as part of this auditing process.
Over the subsequent 25 years, the process has been refined and supplemented with additional requirements such as the auditing of consent form contents and the handling of investigational drugs in institutional pharmacies. Audits by various entities (the NCI, the FDA, pharmaceutical firms, etc) are a fact of life, and fortunately, the process has rarely uncovered instances of scientific fraud. The more important benefit of auditing is that the scrutiny applied by external review of those involved in clinical investigation often results in better compliance with trial requirements and greater accuracy in data collection, to the benefit of all clinical research. Audits also serve as a hands-on educational process for both physicians as well as clinical research associates (CRAs), both when being audited and when invited to be the auditor at another site in their cooperative group.
The announcement that an audit will be conducted in the near future always creates dread and anxiety in those persons to be visited, especially in those closest to the data collection process—the CRAs. In this article, we provide some hints for audit preparation and ways to avoid deficiencies. We draw on our experience with the Cancer and Leukemia Group B (CALGB) audit process for our frequently asked questions. Because all NCI-funded cooperative groups have similar audit programs, the information can be generalized for any such audits, though there may be minor variations depending on the cooperative group involved.
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