The following refers to procedures AFTER agreement between CMB and the projects concerning how projects should proceed with respect to project design and statistical analyses.

Implementation of statistical results analysis.

The project must be designated a “statistician” at the design phase, who will organise for the statistics to be carried out and indicate costs designated for this purpose. The designated statistician will be registered with CMB as part of the Statistician Net.

Implementation of clinical or experimental studies.

(a) Projects must indicate to CMB if there are major changes to the agreed clinical or experimental design, which occur after consultation and agreement with CMB.