Standardised MedDRA queries: their role in signal detection.
Standardised MedDRA (Medical Dictionary for Regulatory Activities) queries (SMQs) are a newly developed tool to assist in the retrieval of cases of interest from a MedDRA-coded database. SMQs contain terms related to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiological test data etc, that are associated with the medical condition of interest. They are being developed jointly by CIOMS and the MedDRA Maintenance and Support Services Organization (MSSO) and are provided as an integral part of a MedDRA subscription. During their development, SMQs undergo testing to assure that they are able to retrieve cases of interest within the defined scope of the SMQ. This paper describes the features of SMQs that allow for flexibility in their application, such as 'narrow' and 'broad' sub-searches, hierarchical grouping of sub-searches and search algorithms. In addition, as with MedDRA, users can request changes to SMQs. SMQs are maintained in synchrony with MedDRA versions by internal maintenance processes in the MSSO. The list of safety topics to be developed into SMQs is long and comprehensive. The CIOMS Working Group retains a list of topics to be developed and periodically reviews the list for priority and relevance. As of mid-2007, 37 SMQs are in production use and several more are under development. The potential uses of SMQs in safety analysis will be discussed including their role in signal detection and evaluation.
Mozzicato
Patricia
P
MedDRA MSSO, Reston, VA 20190-3285, USA. patricia.mozzicato@ngc.com
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000465:Algorithms; D006801:Humans; D007256:Information Systems / Q000458:organization & administration*