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Compliance In Focus


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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

Posted by Sandra Maddock on Wed, Mar 04, 2015

New FDA Draft Guidance: Electronic Source Data

As technology evolves, it is only natural that there will new ways to consider doing the same task. FDA is catching this wave of the future with the new FDA Draft guidance titled, “Electronic Source Data in Clinical Investigations.” As this draft guidance promotes the electronic age we’re evolving into, FDA hopes this will assist source data overall in clinical research.

Topics: Electronic Source Data, FDA Draft Guidance, Federal Register

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.