ENCePP Guide on Methodological Standards in Pharmacoepidemiology

6.2. Timing of the statistical analysis plan

The study protocol will have specified the questions to be addressed in the study and will contain a generic description of the study type and the statistical techniques. However, the statistical analysis plan is likely to be the document in which the statistics to be calculated and tabular and graphical presentations are fully described. Since the decision criteria for the study are specified in terms of the observed values of these detailed statistics, it is worth formulating the statistical analysis plan at an early stage and, in particular, before any informal inspection of aspects of the data or results that might influence opinions regarding the study hypotheses. Ideally the statistical analysis plan will be developed as soon as the protocol is finalised.

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