Awhile back, I was talking to a friend of mine who is also an environmental consultant. He was telling me about a time he hired a subcontractor to tag static water levels. He provided the sub with a map of the site and monitoring well locations and advised him to call him if there were any problems.

About a week later, my friend received the water level data. It was at this time he realized that the map he provided to the sub was a couple years old, and some of the wells had since been abandoned. Apparently, by some miracle, the sub managed to gauge these wells anyway.

?It was good fake data,? my friend told me. ?When I mapped it, all the data points made sense.?? Evidently, the sub had put a lot of thought into it.

What I can?t understand is, why go to all the trouble of making up plausible data as opposed to just calling and saying that you?re having a problem finding the well? Needless to say, the wells were gauged again (for free) by a different technician.

Making Up Data
Making up data is bad, very bad. Even making up data that doesn?t really matter (if there is such a thing) is bad. It calls into question the ethics of the scientist and of the entire company.

I?m sure everyone has read the case of Cetero Research. Six research chemists at the Cetero laboratory in Houston were found intentionally entering inaccurate date/time data as to when tests were being run. Why? So they could claim overtime pay! As Cetero conducted its own investigation, the FDA (informed by a concerned employee) arrived on the scene. Two federal investigations followed, along with a third party audit.

The result of this was that the FDA ruled that there was ?widespread misconduct? and ?if the foundation of the laboratory is corrupt, then data generated will be also.? The FDA ruled that tests run during a 5-year period (April 2005 – June 2010) would need to be repeated and confirmed.

Cetero was quick to point out that the FDA ?has not questioned the safety or efficacy of drugs already approved, marketed and based on data generated.? Lenders were still concerned, though, and Cetero filed for bankruptcy this past March.

Could Electronic Data Collection Help?
If someone is making up data, you want to be able to spot it quickly. So the question is, if you are collecting data electronically, does it help?

Time Stamping
With electronic data collection, you have the ability to see when a record is created and when it was last altered. Obviously, an altered record doesn?t automatically mean data was fabricated (there are legitimate reasons for needing to edit a record). However, if you are having suspicions, it provides a good place to start looking.

Validation Controls
When data are collected electronically, validation can be built in depending on what program is used for its collection.? For example, if pH data are collected, a validation range can be created so that if a technician enters 15, he/she isn’t permitted to save the record. Data fields can be made mandatory so that they aren’t left blank.

Data Available for Review Sooner
I had some sites in Florida where I used a system called Environpro, built using our Adesso software. It collected data offline, then when I was in a wireless hotspot, all the data were automatically uploaded to the central server and were available for review by my supervisor.

I don?t know how the folks at Cetero were recording date/time data.?Regardless, those who want to make up data are going to make up data, no matter how its recorded.?Electronic data collection could make it easier and faster to uncover problems — like what happened at Cetero — before the lives of so many are negatively affected.
 


Written by: Chris Hollinger

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