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Fig. 4 | Trials

Fig. 4

From: Protocol for ICiCLe-ALL-14 (InPOG-ALL-15-01): a prospective, risk stratified, randomised, multicentre, open label, controlled therapeutic trial for newly diagnosed childhood acute lymphoblastic leukaemia in India

Fig. 4

Overview of the clinical trial management structure in ICiCLe-ALL-14. A Trial Management Committee oversees the daily operations of the clinical trial and includes the chief investigators, principal investigators at participating centres (centres 1–5), the laboratory leads for the specialised diagnostic studies, the trial statistician and the coordinating clinical trials unit. The Trial Management Group reports to the institutional review boards at participating centres and to an independent Data and Safety Monitoring Committee (DSMC). Patients are enrolled at six sites, including two sites at centre 1. Centre 3 functions as the nodal centre for the trial, serving as sponsor and housing the coordinating clinical trials unit. An independent contract research organisation monitors participating centres for adherence to Good Clinical Practice (GCP) standards for clinical trials

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Trials

ISSN: 1745-6215