Tuesday, April 28, 2015

Examining the Clin Ops Tool Belt: A Discussion on EMR and eTMF

By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

During the final day of #PCTUS, in the session, “What’s in Your Clin Ops Tool Belt? Weave New Technology into Clinical Development” a panel discussed different systems that optimize and affect clinical operations, revolving around two in particular: electronic health or medical records (EHR/EMR) and electronic trial master files (eTMF). Moderator Joe Popowicz of Emergent Clinical Consulting facilitated a panel made up of Manny Lazaro of Forum Pharmaceuticals, Catherine Dawson of Aesculap, and Elizabeth Brooks of Decision Driver Analytics.


The panel first discussed the advantages and disadvantages of EMR. Utilizing it for site feasibility and patient recruitment can be useful, as sites can figure out how many people they already have in this system with a certain condition, and can even use it for planning (e.g., find hot spots in the country where certain procedures are done). Yet, there are inconsistencies across hospital in codes and definitions that could really skew results.

The next issue the panel looked at was access to EMR. The panel’s experience seemed to be that about half of sites let monitors go in and access their EMR. Getting monitors access to medical charts – whether they’re certifying copies, or the CRA is sitting next to the CRC working through it would be ideal, but if institutions can’t set it up so that the CRA has access to isolate specific patients, they won’t give them access at all.

Another realization is that EMR is only as good as the data that’s entered into the system. There can be many inconsistencies, incorrect codes, errors, missing info, etc., and it would be dangerous to rely solely on it. There is an obvious need for interoperability between EMRs. We’re victims to the fragmentation of our health care system, as each hospital is so different. It seems there are as many limitations as there are opportunities at the present moment, but with a lot of refinement, we can tap into EMR.


eTMF offers access to do ongoing QC there, and there are obvious benefits to this over having the CRA jump on a plane to spend three days sitting in a dark room going through stacks of documents. It’s helpful for the sponsor – using less resources and time on-site and helps with transparency between sponsor and CRO, but the site’s experience is not enhanced. The general concensus was that eTMF is good during the course of trial, but when the call comes in for audit, you might as well just hit the ‘Print’ button. It ends up being counterproductive if you have to print out the entire TMF for any reason.

These technologies will never fully replace the human factor, but have the potential to support and improve the way we run trials, so long as they’re being used as intended. What’s true with any system is garbage in is garbage out, so adoption and proper training is crucial. These technologies will come and go, so it’s interesting to think what the next tool in the belt will be.

About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems​. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015. 

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