TABLE 1: Standardized MedDRA
query terms for identifying potential cases of ILD from clinical and safety databases.
trademark is owned by IFPMA on behalf of ICH.
It may be necessary to conduct hundreds, possibly thousands of tests to discover elevated occurrence of any particular AE from the multitudes of AEs as listed in the medical dictionary for regulatory activities, MedDRA
. And, since the FDA is concerned about identifying potential safety issues, multiple tests at a five percent alpha level are conservative and accepted.
The most important is assigning a standard set of terms contained in a dictionary known as MedDRA
, a hierarchical classification system consisting of four primary levels of specificity and over 20,000 terms.
Now, as part of another contract with AHRQ, she and other KEVRIC staff are matching /mapping MedDRA
And new standardisation of terminology (under an EU-inspired system known as MedDRA
) will become mandatory in the EU from January 2002 for electronic reporting of adverse drug reactions, and January 2003 for all ADR reporting.ICH is already looking ahead.
Medical Dictionary for Regulatory Activities (MedDRA
) preferred terms * that were reported at least twice as frequently as expected for Menveo (compared with all other vaccines) were all associated with administration of only one component of Menveo.
All AEs were reported based on the Medical Dictionary for Regulatory Activities (MedDRA
) system organ classes and preferred terms.
ADRs were coded by MedDRA
with the highest degree of intensity and causality for evaluation including time course and causality.
In this current study, all AEs were mapped using MedDRA
, version 10.1.
Other code systems, e.g., International Classification of Diseases (ICD)-9 (11), International Classification of Diseases for Oncology (ICDO)-3 (12), Systemized Nomenclature in Medicine (SNOMED) (13), MEDCIN (14), and the Medical Dictionary for Regulatory Activities (MedDRA
) (15), provide codes for the answers.
2121 McCloud Consulting Group 502 McGuire Research institute 2041 MedDRA
MSSO 711 Medical Starting Network Healthcare.