Monthly Archives: May 2009

CRF Annotation: A boring Necessity or a part of the QA process ?

Automated creation of an Annotated CRF, and including meta information, can make it a useful part of the QA process. Continue reading

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Minimizing Number of Queries

Proper Edit Check programming can avoid sending needless queries to Sites. Continue reading

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From DataFax to CDISC/SDTM

One of the more recent projects for a client was to export all data from DataFax into CDISC’s Standard Data Tabulation Model (“SDTM”). In this Blog, I want to share some of our experiences with this SDTM export.

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Quality is in the Person, not in the SOP

Having supported DataFax for over 15 years, it sometimes looks as if SOPs are used as an excuse NOT to focus on Quality. If I am convinced of one thing, it is that SOPs are not a guarantee for Quality.

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