Date: Sat, 28 Jan 2006 12:31:55 -0500
Reply-To: Lou <lpogodajr292185@COMCAST.NET>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: Lou <lpogodajr292185@COMCAST.NET>
Subject: Re: Question on Data cleansing in Clinical Trails
"Bhavani Shankar" <bhavani.shankar@INDIA.BIRLASOFT.COM> wrote in message
> While collecting the data from Clinical research organization. I found
> the Blood Sugar value is 460mg/dL in some cases 570mg/dL in one case (=
> Normal value is 64 to 110 mg/dL).
> How do I know whether it is a Data Error while entering the data value or=
> is it the impact of the drug that was administered.
> Please suggest an idea to solve this
If the data were entered via CRF, check back to the original CRF. If the
CRF was transcribed from a lab report, go back to the original lab report.
If instead the data came from the lab in some electronic format, check the
original transfer file.
If the collected units are not mg/dL, make sure the conversion was done
If all of this checks out, and in the opinion of the appropriate data
management personnel the value is suspicious, a query to the site/lab should
be issued so that the value can be confirmed or changed. Possibly, that's
already happened in the normal course of business.
In the meantime, you use the value you have.