Data Collection and Management

EuReDatA Project Report No. 3, Guide to Reliability Data Collection and Management. B. Stevens, Commission of the European Communities, Joint Research Centre, Ispra Establishment, S.P./1.05.E3.86.20... 

Integrated systems using multiple technologies in the areas of communications, data collection, and management have been developed that allow patients to perform and report critical tests at home (Jones et al. [4]). 

Electronic-based data collection and management systems have revolutionized data collection and management. The advantages of such systems over the traditional pure paper-based data collection and management systems... 

Electronic-based data collection and management systems rely heavily on computer hardware and software at both the participating sites and the coordinating centers. The hallmark of the electronic-based data collection and management systems is the elimination of paper data collection forms. Instead of recording data on paper forms, data collectors enter data directly into a computer system where an electronic data record is generated for each form. The method of data transfer to the central location depends on the type of the electronic-based data collection and management system. 

Situations in which proposed trials must await approval and funding before development of the electronic-based data collection and management system can begin present a real challenge to developers in terms of being able to complete the system before the initiation of data collection. Development of a basic system that is easily adaptable will aid in decreasing the time needed for development. 

Electronic-based data collection and management systems use various computer hardware and software technologies. Although some organizations design and develop their own systems, others purchase well-established e-clinical trials software from a wide range of vendors. 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

Web-based data collection and management systems provide a mechanism for remote data entry, where entered data are added to a centralized database once the submit button is pressed. They can be designed to automate the various aspects of clinical trials such as eligibility evaluation, data collection, and tracking specimens. They also serve as a resource site for participating sites to access trial-specific information, facilitate communication, track data queries and their resolutions, and allow administrative management of trials [28, 29]. For these reasons, they play an important role in facilitating the conduct of international clinical trials. 

Various issues must be considered before deciding on the type of the data collection and management system. The wide range of computer programming languages, database management, proprietary software, and hardware provide for the ability to select the most appropriate system design for a trial. 

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