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.