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07:48 Jul 1, 2007
This question was closed without grading. Reason: Other
English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / Clinical trials
Explanation: Safety reporting in clinical trials
A **narrative*** presentation of the data is written by a healthcare professional to put the parameters ***of the case*** into the proper context.
Integrity occurs as the regulatory report is generated and the case is reviewed for quality. A medical doctor ensures that the diagnosis is plausible; the event is coded properly; the classification of the event as it relates to seriousness, expectedness and causality is appropriate; and the narrative is a complete and accurate description of the case.