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Siebel Life Sciences Guide > Investigating Adverse Events and Complaints > Creating Product Issue Assessment TemplatesThe purpose of the assessment is to quantify an evaluation of the product issue. The assessment template is made up of a series of questions about the product issue with an associated list of possible answers. Each question and each answer is assigned a weighting from which a single score is calculated. This value can be used to indicate the risk associated with the issue or whether the issue should be reported to the regulatory agency. This task is a step in Process of Adverse Events and Complaints Investigation. |
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