Articles
Data Management: R.I.P. or Brave New World?
By Timothy Pratt, PhD
Originally published in Applied Clinical Trials, October 2006
Over the past year many data managers have expressed concern about their ongoing roles and livelihoods with the increasing adoption of EDC/eClinical. Add to this concern the following statement: "A wired planet will destroy the need for data management on a project-by-project basis. [EDC] will obviate the need for data management,"1 which was made by a workshop leader at the 2006 Annual DIA meeting. The workshop leader also suggested that massive data manager overstaffing exists at various pharmaceutical companies, and added that radical reform is warranted.
Certainly statements such as these do little to allay the concerns of data managers, and may be based on the false assumption that technology eliminates jobs; often, in fact, technology merely changes the nature of work, largely in an emancipatory fashion. Data managers can and should play a pivotal role in continuing to add value to their companies by helping them transition to the "Brave New World" of EDC/eClinical and realize the promise of these new technologies in overall cost reduction.
Today's Data Management
Data management (DM) has been defined at a high level as encompassing all the disciplines related to managing data as a valuable resource, including acquisitions, database administration, storage, backup, security, and quality assurance. Significantly more complex definitions exist and encompass elements such as reporting and even analysis. What is common is that DM as a discipline may be said to have data quality assurance as its primary function.
Within any given organization, these activities may be performed by a dedicated group or by various individuals within distributed, disparate groups - usually as a secondary function. It is important to note that DM activities are generally performed across all quality research projects, even if the role or department of "data management" does not formally exist. Thus, two frames of reference exist with respect to DM: dedicated and distributed - which will have important ramifications for successful EDC/eClinical implementation.
