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At the recent CDISC Europe Interchange in Geneva, I had the honor of presenting the details of a project mapping clinical data into CDISC SDTM, with a twist. It was a small healthy volunteer study run at a single clinic where the site investigator built the data capture system in REDCap.
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I can actually say that I have been working in the Clinical Trials industry since the last century. I started as a database programmer, part of data management in a large (now huge) CRO. In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse. We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us. Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor. With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?
THOUGHT LEADERSHIP
