Provision of statistics and data management services to Irish Clinical Oncology Research Group Limited by National University of Ireland, Galway

In order to fulfil the regulatory and quality control requirements for high-quality statistics and data management for cancer clinical trials activities ICROG and the HRB have contracted National University of Ireland, Galway to provide this service. Initial data management activities including protocol input, development of a Case Report Form (CRF) and Clinical Data Management System (CDMS) and plan, along with guidelines, validation specification and testing, and training materials for the HRB-CRFG staff, to ensure that cases can be logged, tracked and reviewed. Once established, data management activities will also include patient registrations and tracking, and the development and maintenance of a Data Cleaning Plan, logging of adverse events and the provision of data for any interim analyses, or trial reporting required to Trial Steering Committee (TSC), Independent Data Monitoring Committee (IDMC), Safety Management Committee (SMC). Statistical activities will consist of activities such as the provision of advice on objectives, outcomes, design, data collection, and sample size; consideration of the rationale for any interim analyses along with the stopping rules and provide of the statistical section of the protocol; advise on, review, and sign off on the CRF and database validations; During clinical trials the statistical activities will include processing and analysis of data for any interim analyses and compilation of reports and accrual reports to the sponsor and funders; advise and review of protocol amendments and provision of reports to the Commitees as required e.g. IDMC, SMC; and in close out period liaise with the data manager on data cleaning and data handover and with the CL and sponsor on the technical report; undertake final technical report, advise on presentation and interpretation of results for publication and document and archive derived datasets, computer code, and results.

Award Date
26 June 2015
Award Value
€1,283,839
Principal Investigator
Professor Martin O'Donnell
Host Institution
National University of Ireland, Galway
Scheme
ICORG Statistics and Data Management