Linked Up

EDC provider OmniComm has announced that it has finalized plans to link its TrialMaster EDC with an electronic medical records platform: MS HealthVault.  This plan would allow for those patients or providers using this medical records system to seamlessly upload their records to the EDC system. Sites using paper records are currently stuck in a perpetual battle with ensuring that the information they report about trial participants is accurate and up to date.  Such a connection between electronic records and EDC would eliminate the need for tedious data entry for medical history and allow for the inclusion of more detailed participant history into the trial database.  I imagine there could be all sorts of interesting trends that could be gleaned from the merger of EDC and patient records, likely going above and beyond what is possible today.

The one thing that this merger of EDC and EMR would need to recognize is that patient confidentiality has to be maintained.  There has to be some sort of mechanism to remove confidential patient identifiers from the records before transfer into the EDC system while at the same time allowing for identification of patient in the trial database (by date of birth, initials, etc).  Check out this link for more information: OmniComm

Also, in an unrelated note, I think it's worth mentioning the importance of organization for clinical trial sites.  If a site is audited one of the worst things that can happen is to have files in a state of disarray.  This will frustrate the auditor (amongst other things), and cause he/she to start looking more closely for problems.  Yes, the auditor is there to perform a detailed review of the study files, but it's in the site's best interest to make the auditor's job as easy as possible.  One of the best ways to do this is having everything in order because uniformity, clear labeling, and precise filing can do wonders for a site.  More to come on this later...