I had an interesting question come up today from a research manager whose site has recently switched to an EPIC EMR system. She asked if copies of data that she had printed out of EPIC for source document verification for an upcoming visit would be adequate for purposes of source document verification.
We all know that source documents are the gold standard for data verification. Monitors and auditors ideally should be granted direct access to this information in order to verify study data; however with the plethora of concern surrounding private health information and individual privacy it seems to be getting more difficult to access this information easily.
FDA regulations do not address certified copies or direct access to source data, however these terms are discussed in the ICH E6 Guidelines for Good Clinical Practice and in FDA’s ‘Guidance for Industry Electronic Source Data in Clinical Investigations’ document. ICH E6 1.21 defines direct access as “Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial”. Further ICH E6 5.15.1 directs sponsors to ensure “that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection”. In it’s September 2013 Guidance document on Electronic Source Data, FDA defines certified copy as “a copy (paper or electronic) of original information that has been verified, as indicated by a dated signature, as an exact copy, having all of the same attributes and information as the original “.
In my opinion, the key issue here is the robustness of the data verification process and what written documentation is available to support equivalency of copies of data to the paper or electronic source documents themselves. Is direct access really necessary? Or will review and verification of copies of data be sufficient? What about using certified copies of EMR data for verification purposes? I’d be interested in your thoughts on this important topic.