Articles
Data Management: R.I.P. or Brave New World?
By Timothy Pratt, PhD
Originally published in Applied Clinical Trials, October 2006
The Prime Objectives
Irrespective of the frame of reference and subsequent view of DM (whether as a dedicated or distributed function), the
set of objectives sought can be operationally defined in research as those activities that ensure the data and its database(s) are:
- accurate - it represents the data submitted
- precise - the data are clear, unambiguous, and serve to answer the research question
- compliant - it meets various FDA and ICH requirements
- timely and accessible - assuming the foregoing is addressed, the data are readily available for various degrees of review and analysis.
If the above prime objectives are met, then data quality will be assured, and thus the data will have been well managed.
