Composition of the coordinating center and trial steering committee {5d}
DEL, RECRUITMENT
The coordinator center is based at the Università del Piemonte Orientale and includes Rosanna Vaschetto (principal investigator), Nello De Vita (research physician), Eduardo Rocca (research physician), Alberto Dal Molin (research nurse) e Lorenza Scotti (methodologist). Coordinator center tasks will consist in preparing protocol and revisions; designing CRFs; organizing steering committee meetings; managing and controlling data quality; designing, testing, and maintaining the electronic data capture system; assisting the steering committee; managing the research centers; selecting and training the research centers; helping the centers prepare all the necessary documents to be submitted to research ethics boards (REBs) and assisting centers with submission; monitoring recruitment rates; sending study materials to the research centers; complete statistical analysis; and writing and publication of study protocol and final manuscript.The trial steering committee is composed by Cesare Gregoretti (lead investigator), Annalisa Carlucci (lead investigator), Andrea Cortegiani (lead investigator), Claudia Crimi (lead investigator), Alessio Mattei (lead investigator), Raffaele Scala (lead investigator), Federico Longhini (lead investigator), Gianmaria Cammarota (lead investigator), Giovanni Misseri (lead investigator), and Paolo Navalesi (senior lead investigator). The trial steering committee responsibilities will be agreement on the final protocol, recruitment of patients and liaising with the principal investigator, reviewing the progress of the study, and if necessary agreeing on changes to the protocol and/or investigators brochure to facilitate the smooth running of the study, agreement on the final manuscripts.