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Coordinating trial center: Administrative, technical and material support: F Carrat, L Canini, P Ferrari, R D'Angelo, F Chau (UMR-S 707), M Lafaye, L Rouxel, L Piazza, A Bergera (DRRC AP/HP).
Feasible patients are assessed by the participating study centers and registered to the coordinating trial center.
Four coordinating trial centers (Bochum/Dortmund, Mainz, Düsseldorf/Köln and Bad Mergentheim) organized the recruitment activities in the diabetological trial centers located in their vicinity.
*11 additional babies born to staff at AVERT Central (the central coordinating trial site) were not included because the staff did not recruit patients.
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The logistical problems relate to the rapid identification of the extra resources required to allow continued excellence in day-to-day management and monitoring of trial governance (both in participating centres and in coordinating trials units).
ITR is non executive director of the North Wales Clinical Trials Unit which will coordinate trial management and scrutiny.
ME and JR designed the questionnaires, coordinated trial field-work, acquisition of data and follow-up.
Our pilot has also demonstrated feasibility through our ability to recruit patients efficiently; investigator compliance with key aspects of the protocol; maintenance of data quality; maintenance of high follow-up rates; and the research team's ability to organize and coordinate trial procedures in a multinational trial.
The Wales Cancer Trials Unit, a Cancer Research UK core funded and National Cancer Research Institute accredited Clinical Trials Unit, is coordinating the trial.
The critical lessons were the need for excellent communication between all parties in the chain: from CRN to pathologist to the central laboratories to the coordinating trials unit.
All respondents who preferred patients to receive results by post were also asked if, in principal, they thought ICR-CTSU as the coordinating trials office, should in future hold addresses so they could send results directly to patients' homes.
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