Clinical trials data collection/management

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]. 

Systems audits in this late phase in clinical trials aim at assessing related procedures to ensure that capable procedures exist for managing and cleaning clinical trial data, for conducting statistical analyses and for preparing the final study report which represents properly the data collected and reported in the clinical trial. Such systems audits are performed across functional boundaries. Such systems audit can be combined with a database audit and/or an audit of the final study report. 

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. 

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. 

Abdellatif M, Reda D. A Paradox-based data collection and management system for a multi-center randomized clinical trials. Comput Methods Prog Biomed 2004 73 145-64. 

Abdellatif A, Motyka D, Williams D, Reda D, Kucmeroski D, Fye C, Clegg D. A data collection and management system for clinical trials in osteoarthritis. Clin Trials 2005 2 S71. 

Table 2.8. Typical issues addressed when designing a clinical trial protocol. The trial objectives should clearly define what questions the trial should answer. The study design section should contain comprehensive information detailing trial size, criteria used to choose the study population, and enrolment procedures. Description of intervention section should give the background to the intervention itself, its therapeutic rationale and how it is to be administered. Measurement of response should detail the data to be collected, how it will be collected and analysed. The organization and administration section should give full details of all the investigators, where the trial is being run, and its project management details...

An Interactive Voice Response-System (IVRS) is a communications platform based upon the telephone network used to coordinate key clinical trial activities and provide real-time information for study managers. By utilizing the telephone network, the system provides for a direct connection between the clinical trial patient and the central study-specific database. This permits the collection of data in response to preprogrammed prompts from the system, ensuring the recording of key trial events and the provision of information critical to the successful conclusion of the trial. Most IVR systems are individually tailored to each specific study based upon requirements defined by the Sponsor. 

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