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The reasons for performing risk assessments may vary, but common to all is that they are done to provide input to decisions. It is therefore important that the study team understands the decision alternatives and gives clear and specific answers that can be used in the decision‐making process. If the objective of the risk assessment is not clear from the beginning, it is not likely that the assessment will answer the questions that need to be answered to support the actual decision‐making.

The study team needs to know who the users of the results are and their knowledge about risk assessment. The users may influence both how the risk assessment should be carried out, and particularly, how the results should be presented. If the users are risk assessment experts, the presentation of results and the use of terminology may be different compared to if the users have no or little experience with risk assessment.

If risk acceptance criteria for risk evaluation have been established, these must be known to the study team such that the results from the risk assessment are given in a format that enables comparison with the criteria (see Chapters 5 and 6). A good understanding of these criteria and how they should be interpreted is essential.