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Questions & Answers of webinar (Feb 2015) on Signal detection methodology: Current and Novel approaches

5th Mar, 2015

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Questions & Answers of webinar (Feb 2015) on Signal detection methodology: Current and Novel approachesThis Questions & Answers Blog are from Signal Detection Webinar conducted in February 2015.

1) Which level of grouping or selection for AE term is used?
Usually the Lowest level term (LLT) that precisely reflects the reporter’s verbatim should be selected. However, the MedDRA coder should also check the hierarchy of the terms selected (i.e., PT, HLT, HLGT and SOC) as it is also important to select the LLT falling under correct hierarchy which otherwise would lead to erroneous coding.
Also, it is equally important to ensure good coding practices by establishing company procedures and having a quality check so as to ensure correct information as is reported goes in the case. In PvNET, when an LLT term is selected, the system automatically enters the related PT term in the data field.
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