Organisational structure and responsibilities Chief investigator and the clinical trials unit Design and conduct of ICiCLe-ALL-14 Preparation of protocol and revisions Preparing reports to data monitoring committee, funding organisations and  Institutional Review Board (IRB) Maintaining database, data verification, randomisation Organising trial management committee meetings Managing the Clinical Trials Office Publication of study reports Trial Master File management Trial management committee Includes lead trial clinicians from participating sites (ShB, SaB, AT, VR, RS, GN, SS, VS and SK; see title page) Protocol discussions Review of trial operations (enrolment, data capture) Review of adverse events Review of study progress and requirement for protocol modifications Trial monitoring National Cancer Grid Contract Research Organisation