Tuesday, April 17, 2007

The squeaky wheel gets asked to please provide grease

All last week one of my most time-consuming projects was going through database updates. As of Monday it was up and running again and I got to go play with the new system. Wow they messed things up. A basic example: Height and Weight values that didn't contain a decimal place of ".0" were flagged as non-conformant data. This means every value has to be re-opened, verified w/ the source documents, re-entered, re-saved, and re-checked for accuracy by the monitor. I have no problem with entering a decimal place generally, but retroactively deciding this is necessary for 56 patients who have been in our office up to 9 visits each tends to add a bit to the workload. There were 12-15 data points affected by the changes made (*56, *up to 9 occurences for each data point), plus an untold number of Con Med and Adverse Event entries. My personal favorite involved the Physical Exam page...the "Dentition" (do they have teeth?) values were changed from Normal vs. Abnormal to Unremarkable vs. Clinically Significant. Everything that had been entered previously, Normal or Abnormal, was therefore lost and must be re-entered.

Being the meticulous person I am, I typed up a couple emails to the site director detailing how much was being asked of us and how long these changes would take me (between 10-90 min/patient, depending on different things). These weren't whiny diatribes about "waaaaa, don't wanna!!!," these were informative details of what was going on. See, we get paid by sponsors based on how much of our time their study takes, so me spending an extra hour+ getting each of the 56 data sets up to where the new system requires makes a difference in our contract and therefore site revenue. Apparently these emails were forwarded, discussed at length internally and w/ the sponsor, and today I received instruction to stop scrambling to make the fixes.

Turns out they're going to take back a lot of the questions their system asked, see what they can fix on that end, negotiate an addendum to the contract, and then do some sort of phased rollout of datapoint queries/updates. This is great news...but then they decided that since I provided such careful feedback the Denver site will basically be a beta-test site throughout this process. I guess that's flattering :-P The more positive bit is that my site director was happy with me and people further up the food chain know who I am now apparently. Now I have to work up the courage to ask for more money!

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