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Compliance In Focus


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Posted by Mary Lewis on Tue, Jun 23, 2015

Direct Access to Electronic Medical Records for Data Verification

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.

Topics: Electronic Source Documentation, EMR, SDV, Direct Access

Posted by John Lehmann on Wed, Mar 04, 2015

FDA Issues Final Guidance on Electronic Source Documentation

The FDA issued its final guidance on electronic source documentation.  Back in January 2012 the FDA published its draft guidance to much criticism and debate. The new guidance broadly follows the second draft of the guidance which was released in November 2012.

Topics: FDA Guidance, Draft Guidance, Electronic Source Documentation

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