This 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 Sarjen’s PvNET, when an LLT term is selected, the system automatically enters the related PT term in the data field.
(more…)
If a Marketing Authorization Holder (MAH) nurtures a molecule and gives it a proper shape in form of a palatable dosage form with various types, i.e., in different strengths and route of administration(s), they also are required to keep a track-record of how the product is behaving in pharmacokinetic, pharmacodynamic and more so, pharmacogenetic pattern, once marketed.
Signal detection and validation by Marketing Authorization Holders is an integral pharmacovigilance activity and should be carried out intermittently because ‘Signal’ may pop up out of the blue necessitating appropriate evaluation or justification, as the case may be.
Well-defined pharmacovigilance systems and transparent data analysis need no deeper diggings and is self-explanatory!