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Every effort will be made to minimise missing baseline and outcome data in this trial, but prior to data analysis, the level and pattern of the missing data will be established and the likely causes of any missingness investigated.
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This will be the ultimate home of the data and will be established in advance of data collection.
Further, the data warehouse will be established in a format that will allow future uses beyond the project as an accessible resource for researchers external to the project.
The IMPACT data platform will be established as a permanent resource enabling other investigators with an interest in AYA cancer to perform their own investigation into AYA cancer.
An independent data monitoring committee will be established, with terms of reference.
Data analysis protocols will be established and performed centrally by a statistical analysis task force.
Owing to the small size of the trial and the relatively short study duration, no data monitoring committee will be established and no interim analyses will be conducted.
A data monitoring committee will be established comprising an external statistician, a clinical expert and an expert in RCTs to check the randomisation and undertake an interim analysis.
An independent data monitoring committee will be established, with terms of reference jointly defined between trial investigators and the independent committee members prior to study commencement.
Also, in this respect, further improvement of the implementation of clinical data and genotype phenotype correlates will be established by the implementation of phenotypic ontology [Köhler et al., 2012], allowing to associate genetic variations with specific clinical characteristics rather than disease diagnoses.
No data safety and monitoring board will be established since the interventions are extremely safe and already delivered to hundreds of millions of individuals each year as part of national deworming programmes.
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