SafetyGlossary Term
An internationally standardized medical terminology developed by ICH to facilitate the electronic exchange of regulatory information for medical products throughout their lifecycle.
MedDRA provides the standardized terminology that enables consistent coding of adverse events, medical history, and other clinical observations across clinical trials, post-marketing surveillance, and regulatory submissions worldwide. Developed under the auspices of ICH and maintained by the MedDRA Maintenance and Support Services Organization, this hierarchical dictionary ensures that safety data can be aggregated, compared, and analyzed across different studies, sponsors, and regulatory jurisdictions using a common vocabulary.
The MedDRA hierarchy comprises five levels of increasing specificity. System Organ Classes represent the highest level, grouping terms by etiology, manifestation site, or purpose. High Level Group Terms and High Level Terms provide intermediate groupings that facilitate data retrieval and review. Preferred Terms represent distinct medical concepts used for clinical data entry and analysis, while Lowest Level Terms provide the most specific terminology available. This hierarchical structure allows safety data to be analyzed at multiple levels of granularity, from broad system organ class comparisons to specific preferred term frequencies.
Medical coding using MedDRA occurs as part of the data management process, with trained coders assigning appropriate terms to verbatim adverse event descriptions reported by investigators. The selection of the most appropriate term requires clinical judgment and adherence to coding conventions, as inconsistent coding can obscure true safety signals or create artificial patterns. Regular version updates to MedDRA necessitate careful management to ensure that coding within a study remains consistent while also incorporating important new terms that may better represent observed events.
Adverse event coding
"The investigator reported "stomach pain" as a verbatim adverse event term, which the medical coder mapped to the MedDRA Preferred Term "Abdominal pain" within the Gastrointestinal disorders System Organ Class."
Safety signal detection
"Aggregating adverse events at the High Level Term level revealed an unexpected clustering of "Hepatic enzymes increased" events in the treatment group, prompting a comprehensive review of all hepatic-related Preferred Terms."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
An internationally standardized medical terminology developed by ICH to facilitate the electronic exchange of regulatory information for medical products throughout their lifecycle.
MedDRA provides the standardized terminology that enables consistent coding of adverse events, medical history, and other clinical observations across clinical trials, post-marketing surveillance, and regulatory submissions worldwide. Developed under the auspices of ICH and maintained by the MedDRA Maintenance and Support Services Organization, this hierarchical dictionary ensures that safety data can be aggregated, compared, and analyzed across different studies, sponsors, and regulatory jurisdictions using a common vocabulary.
The MedDRA hierarchy comprises five levels of increasing specificity. System Organ Classes represent the highest level, grouping terms by etiology, manifestation site, or purpose. High Level Group Terms and High Level Terms provide intermediate groupings that facilitate data retrieval and review. Preferred Terms represent distinct medical concepts used for clinical data entry and analysis, while Lowest Level Terms provide the most specific terminology available. This hierarchical structure allows safety data to be analyzed at multiple levels of granularity, from broad system organ class comparisons to specific preferred term frequencies.
Medical coding using MedDRA occurs as part of the data management process, with trained coders assigning appropriate terms to verbatim adverse event descriptions reported by investigators. The selection of the most appropriate term requires clinical judgment and adherence to coding conventions, as inconsistent coding can obscure true safety signals or create artificial patterns. Regular version updates to MedDRA necessitate careful management to ensure that coding within a study remains consistent while also incorporating important new terms that may better represent observed events.
Adverse event coding
"The investigator reported "stomach pain" as a verbatim adverse event term, which the medical coder mapped to the MedDRA Preferred Term "Abdominal pain" within the Gastrointestinal disorders System Organ Class."
Safety signal detection
"Aggregating adverse events at the High Level Term level revealed an unexpected clustering of "Hepatic enzymes increased" events in the treatment group, prompting a comprehensive review of all hepatic-related Preferred Terms."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.