Well, here we are again, trying to get the last blog in before we go back to school!

Hope everyone had a wonderful summer….the Octagon team here has been hard at work trying to perfect our current ViewPoint FUSE system while planning for our next major release at the end of the 4^th Quarter. With all the excitement surrounding this next release, it got us thinking of how exciting EDC really is!  I mean, to be able to have data at your fingertips once entered and for it to be so clean because edit checks fire upon entry is amazing.

Of course, over the past few years we have not seen as many people embrace EDC in the industry as we originally thought. So, the question is why has it taken EDC so long to over take paper-based trials and why are people still unhappy with EDC?  After speaking with some of our associates in the industry, we realized that there are many reasons why EDC is not as “on fire” as it should be.  One reason we are focusing on today is process.

EDC is meant to be an Electronic means of capturing clinical trial data.  Electronic is the key here….this means a change in process and procedures for all those involved. No longer is the primary onus on Data Entry staff to enter the data, now the study coordinator acts as the DE staff. They enter the data into the EDC screens and edit checks “fire” online indicating possible entry or transcription errors. So the work which DE staff would manually do is already done.

This does not mean that Data Management goes away completely. Staff still needs to clinically review forms for overall accuracy. They still need to check those things which a computer is never going to find, like an exacerbation of a Medical History which should be recorded as an Adverse Event. But, the highlight here is a change in paradigm…a shift in responsibilities.

And lets not forget about the all-important CRA role. They still need to source doc verify 100 % of all forms, however, they are not spending their time highlighting blank values, or values outside of the range because the system does it for them. So, they can spend most of their time performing true CRA tasks:  Reg Doc Review, Drug Accountability and Monitoring Reports.

The take home message of this installment is that to force an antiquated process on a new shiny product like EDC is not fair. Times are a changing….process needs to as well.

Blog you later…………D & D