MedDRA synonyms
MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology, published by the International Council for Harmonisation, that is used specifically to code and standardize adverse effects (AEs), medical conditions, indications, medical and surgical procedures, pharmacogenetic terms, toxicological issues, and more, in clinical trial reports and pharmacovigilance databases and to facilitate searching in these databases.
In MedDRA, data is usually presented at the Preferred Term (PT) level, but coding is mostly performed at the level of highest granularity, which is the Lowest Level Term (LLT). Depending on the sponsor's SOP/coding convention, both of these may be used when coding terms.
MedDRA synonym is a term that has the same or similar meaning in the context of the Medical Dictionary for Regulatory Activities. MedDRA synonyms are important because they help ensure consistency in the way that terms or data are identified and classified across different clinical trials and pharmacovigilance databases.
In the Pharmacovigilance (PV) application, there is a feature called MedDRA Synonym that is designed to give you complete control over the configuration and management of MedDRA synonyms. With it, you can tailor the MedDRA dictionary to the specific requirements of your clinical trial or pharmacovigilance program.
For example, "headache," "cephalalgia," and "migraine" are all terms that can be used to describe pain in the head. If various terms are used to describe the same AE, it can make it difficult to compare data across different clinical trials and to analyze safety signals. By configuring MedDRA synonyms, you ensure that all AEs are consistently identified and classified using the same MedDRA terminology, making it easier to analyze safety data across multiple studies and databases.
In this section, you will learn how to:
-
Review MedDRA synonyms that have already been added and configured for your clinical trial.
-
Add a new MedDRA synonym if new medical terminology is introduced or if regional or local terms are used to describe a condition.
-
Edit an existing MedDRA synonym if, for example, the verbatim term changes or when the mapping of the synonym needs to be updated to correspond with a different MedDRA term and code.
-
Activate a previously deactivated MedDRA synonym, making it available for use again.
-
Inactivate a MedDRA synonym, preventing it from being used in coding and analysis.
-
Access the audit trail for MedDRA synonyms to view a short summary of any changes made, including who made the change and when.
-
View a complete history of all actions taken on a MedDRA synonym, including when it was created, modified, and deleted, as well as any other relevant details.
-
Export the list of MedDRA synonyms as an Excel file and work with them offline, outside the PV application.
-
Import MedDRA synonyms from a local file to quickly add multiple synonyms to the PV database.
-
Permanently remove a MedDRA synonym from the PV database.