Frequency and plans for auditing trial conduct {23}
fever
ADVERSE REACTIONS, EVENTS, SECONDARY, RECRUITMENT
The CRA is a person independent of the research team who is not involved in patient recruitment and follow-up.The local CRA makes a start-up and closing visit to each site. A first visit will take place in each center 30 days after the inclusion of the first patient. Subsequently, 4 to 6 visits will be performed per site, with a frequency of 1 visit every 4 months.During the monitoring visits, 100% of the informed consents form, selection criteria, events and adverse reactions, and main and secondary variables (neutrophil counts, fever, study treatment, stored samples) will be reviewed. The remaining the variables will be reviewed every 5 patients.