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MONITORING AND SUPERVISING A DIETARY INTERVENTION TRIAL USING MODERN DATA PROCESSING SYSTEM

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MONITORING AND SUPERVISING A DIETARY INTERVENTION TRIAL USING MODERN DATA PROCESSING SYSTEM

M. J. Koski

1

, J. P. Krischer

2

1

Institute of Clinical Medicine, University of Helsinki, Helsinki, Finland,

22

DMU, H. Lee Moffitt Cancer Center Research

M

M Institute, University of South Florida, Tampa, United

States

Introduction: The recruitment for TRIGR started May 2002 and will continue until spring, 2006. Present status of TRIGR: 71 participating centers from 15 countries on 3 continents, by June 29, 2004 2398 families have been registered and 2028 infants have been randomized, 868 infants continue in the intervention after HLA screening from cord blood.

Methods: The Data Management Unit (DMU) established an electronic web- based data capture system for TRIGR. Study data is collected world wide using on-line web-based forms. The Oracle (internet) database is open continuously and the data can be entered round the clock. The data entry forms are linked to on-line logical controls and checks to reduce input errors. The TRIGR staff members have their own User Id and Password and the system is monitoring and keeping track of data entry and editing constantly. The laboratory data are captured to the DMU database using the FTP technique (File Transfer Protocol) via Internet. The tracking system for interviews, visits and blood samples is also available. Study Centers are asked to use it to report whether the scheduled contacts with the participating families have occurred. The tracking system has been designed to facilitate the monitoring of the Study Centers' compliance efforts. The Sametime videoconferencing program offers TRIGR Study members an inexpensive and effective alternative to e-mail, telephone calls and in person meetings on real time basis. To be able to design such a system, to get it ready on time, you need to have experienced staff with special knowledge and previous experience of similar trials. The management of an international multicentre intervention trial would be extremely complicated and challenging without modern technique.

Conclusions: The current system has proven its efficiency in monitoring, recruitment and compliance in study centres within TRIGR.

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