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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 Mary Lewis on Wed, Mar 04, 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.

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

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