There are extensive sources of guidance on study design and statistical analysis from the EU Commission and many others. These, together with a statistician, should be consulted at an early stage. Direct oversight by a statistician is likely to be more effective than reliance on self-education from textbooks and websites, although many of these are excellent. An outline of the stages of the programme should be provided, indicating how each protocol will be used to achieve the objectives. Provision of a flow diagram or process map may be helpful. In addition to those elements described later in PREPARE, the following points should be considered:
- A clear hypothesis and descriptions a priori of primary and secondary outcomes, to avoid HARKing.
- Steps to minimise numbers and suffering of animals by appropriate statistical analysis, including the use of pilot studies.
- Decisions on the power and significance levels to be used.
- Definition of the experimental unit and number of animals in each unit
- Choice of sample size and gender, age and/or developmental stage
- Avoidance of bias, including “blinding” and randomisation (the procedure should be specified)
- Inclusion and exclusion criteria
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