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The clinical research community continues to struggle with privacy protections and the subsequent limitations on direct access to electronic health records (EHR) for monitors, auditors and even regulatory authorities. Since these EHRs house the original source data supporting regulatory approvals, some level of source document verification is expected.
We'll discuss the risks and benefits of a number of 'alternative' methods being used to provide access to source documentation. Some examples include the use of source document worksheets, provision of "certified copies" of electronic source documents and using the CRFs as a source. In the spirit of Risk-based initiatives, research sites and sponsors need to work together to ensure accurate, reliable data are obtained and reported. This session will describe the concept of Case Report Form mapping and explain the potential benefits of implementing this procedure early in your clinical study planning activities. Participants should be prepared to engage in interactive discussion of this issue.
Why should you Attend:
Are you concerned that your monitors may not have full access to source documentation when an Electronic Health Record system is being used? Do auditors and regulators get more access than your monitors do? If so, you have a fairly significant risk that your source document verification (which supports your application and impacts your regulatory reporting requirements, i.e. for missed reporting of SAEs or UADEs).
If you are tired of constantly changing data, either when a new Clinical Research Coordinator takes over a study or when a new monitor is assigned, this course may be for you. We will discuss how CRF Mapping can provide a 'road map' for consistent data capture to support the CRC, CRA and auditors/regulators tasked with evaluating the accuracy of the data and the procedures used to obtain it.
Areas Covered in the Session: