Selecting an Electronic Data Capture System

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Abstract

Introduction:

Investigators encounter numerous challenges when initiating a research project, including selecting an appropriate electronic data capture system. Options range from simple stand-alone spreadsheets to full service, relational databases controlled by certified database administrators. We present an overview of the issues to consider when selecting an electronic data capture system and a survey of available software solutions. We also discuss how to select an electronic data capture system that best meets the data management needs of the study.

Methods:

We compared software solutions based on several regulatory and budgetary issues that should be considered by investigators. Regulatory issues include HIPAA (Health Insurance Portability and Accountability Act), case report forms and adverse event reports. Technology costs, ease of use and expertise of personnel are examples of budgetary matters.

Results:

Stand-alone spreadsheets require extra attention to regulatory matters but are intuitive to investigators. Large-scale relational database management systems can be configured for all regulatory matters but require dedicated effort from a certified database administrator, greatly increasing data management costs. Low cost, server based solutions sacrifice some of the flexibility of a relational database management system in exchange for being extremely easy to design and manage. Software as a service is a scalable third party solution. Cloud based systems are a new solution that are not widely used in institutional review board approved research.

Conclusions:

Due to the extensive resources required to implement an electronic data capture system it is important to carefully analyze and understand what options are available. In this way the most informed choice can be made.

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